Pursuant to section 7208(k) of the Intelligence Reform and Terrorism Prevention Act of 2004 (IRTPA), 118 Stat. 3638, as amended by section 565 of the Consolidated Appropriations Act, 2008, 121 Stat. 1844, codified at 8 U.S.C. 1365b, the Department of Homeland Security (DHS) published a notice of proposed rulemaking (NPRM) in the Federal Register on November 19, 2009, proposing to establish an international trusted traveler program called Global Entry. See 74 FR 59932. As described in the NPRM, the Global Entry program is modeled after the Global Entry pilot program, which has operated since June 6, 2008. For more information about the pilot and CBP's other trusted traveler programs, please refer to the Global Entry pilot notice published on April 11, 2008 (73 FR 19861) and the Global Entry NPRM published on November 19, 2009 (74 FR 59932). As explained in the NPRM, CBP published several Federal Register notices that established the pilot, expanded the Global Entry pilot to include additional airports, and expanded eligibility for participation to include certain citizens of the Netherlands who otherwise satisfy the requirements for participation in the pilot. See 73 FR 19861, 73 FR 30416, 73 FR 47204, 74 FR 18586, and 74 FR 39965. Additional details regarding the growth of the pilot and the proposed rule also may be found on the Web sites www.globalentry.gov and www.cbp.gov.

This final rule adopts, with some changes, the NPRM published in the Federal Register on November 19, 2009, which proposed establishing Global Entry as an ongoing voluntary regulatory program. This final rule addresses all of the public comments received and provides Global Entry participants with all the relevant information. There were several minor changes made to the NPRM ( see Section III B). The only significant change is that minors under the age limit of 14 are now permitted to apply to the Global Entry program. This change will allow more families to enjoy the benefits of the program and is in direct response to feedback from the public.

After publication of the Global Entry NPRM, CBP published an additional Federal Register notice on December 29, 2010, to expand eligibility for participation in the Global Entry pilot to include qualified Mexican nationals who have been vetted by both CBP and the Government of Mexico and satisfy the program's eligibility requirements. See 75 FR 82200. This expansion implements the Joint Declaration between DHS and the Secretariat of Governance of the United Mexican States, through the National Migration Institute. Since the publication of this Federal Register notice, CBP has been accepting applications from Mexican nationals who are interested in participating in the Global Entry pilot program. As of March 25, 2011, CBP has enrolled 396 Mexican nationals into the Global Entry pilot program. As explained in Section III A4, this rule announces that Mexican nationals who meet eligibility requirements can enroll in the Global Entry program. It further specifies that the rule serves notice that upon its implementation, Mexican nationals who are existing participants in the Global Entry pilot will be automatically enrolled in the ongoing Global Entry program.

In another Federal Register notice published on December 29, 2010 (75 FR 82204), CBP expanded the NEXUS and Secure Electronic Network for Travelers Rapid Inspection (SENTRI) trusted traveler programs to allow participants of those programs use of the Global Entry kiosks. This rule does not change that. After implementation of this rule, participants in NEXUS and SENTRI will still be allowed to use the Global Entry kiosks.

Below is a table outlining when various provisions of the rule were introduced into the program:

CBP solicited public comments to the Global Entry NPRM and the individual Federal Register notices pertaining to the pilot, including the most recent notices involving the expansion of eligibility to Mexican nationals and allowing SENTRI and NEXUS members to use the Global Entry kiosks. This final rule addresses all comments received in response to the NPRM and the individual Federal Register notices.

CBP received four comments in response to the Federal Register notice announcing the pilot, one comment in response to the Federal Register notice expanding eligibility to Mexican nationals, and ten comments in response to the NPRM. In total, CBP received 15 comments on the NPRM and three notices.

Of the fifteen total comments, ten are favorable, two are neither favorable nor unfavorable, and three were unfavorable. The favorable comments include both positive statements regarding the program and suggestions of various avenues in which CBP might expand Global Entry. For example, two of the favorable comments recommend that Global Entry include a role for the private sector. The two neutral comments include suggestions for expansion of the program but include neither positive nor negative statements regarding the program itself. Only three comments can be categorized as generally unfavorable, in that they focus primarily on possible problems that might arise.

The following section groups the comments, along with CBP's responses, by category.

Comment: Several commenters made general comments about how the Global Entry pilot expedites or will expedite the entry process for participating travelers. One commenter stated that Global Entry is one of the most successful service initiatives taken by CBP in recent years and has the potential to significantly improve the entry process for returning citizens and legal residents, improve the productivity of CBP's gateway teams, and ease restrictions on the flow of international travel (through reciprocal arrangements with other countries) upon which our economy depends. Another commenter stated that Global Entry has the potential to facilitate and expedite the arrival of international travelers while enhancing security by allowing CBP to focus its inspection resources on passengers who have not been previously vetted. Another commenter, a frequent user of Global Entry, has found the pilot to be easy to use, reliable, and accessible, and a huge advantage in clearing customs upon re-entry into the United States, especially during times of peak volume.

Only one commenter criticized any aspect of the day-to-day operation of the program. In an otherwise favorable comment, the commenter asserted that its organization has received some feedback from Global Entry pilot enrollees regarding sporadic problems experienced involving confirmation of the individual's identity at Global Entry kiosks and that some CBP officers did not possess the requisite knowledge to assist with the problems.

Response: CBP agrees with and appreciates the favorable comments regarding the current benefits of the Global Entry pilot and the future benefits of the Global Entry program, which include the expedited processing of low- risk international travelers.

The Global Entry pilot is operating successfully. As of June 6, 2011, over 198,000 applications were filed and over 148,000 participants were enrolled. The automated kiosks are working smoothly with no current major technical issues or problems. The kiosks have been used over 1,014,000 times. The increased volume of traffic to the kiosks by proven low-risk travelers allows CBP officers more time and resources to address higher risk security concerns. CBP is approving applications for participation more quickly than was initially expected. The average approval time for each application has been less than one week—better than the initial estimates of ten to fourteen days.

DHS has conducted an analysis of wait times for Global Entry pilot participants based on data for 1,575 flights with at least one Global Entry passenger onboard from November 19, 2008 to January 9, 2009. That analysis indicates that participation in Global Entry may reduce a passenger's wait time by up to seventy percent—or an estimated seven minutes on average. It further demonstrates that participation in Global Entry reduces the variability of wait times. Less than one percent of Global Entry passengers wait longer than twenty minutes while approximately ten percent of all U.S. citizens and U.S. Lawful Permanent Residents (LPR) wait longer than twenty minutes. The analysis shows that Global Entry participation varies by airports, airlines, and the region from which the flight originates.

Regarding the comment concerning sporadic operational problems at kiosks, CBP is continuously sending guidance to its field personnel regarding operational issues. CBP incorporates the comments, complaints, and inquiries regarding the program that it receives from the public into this guidance to improve operations. When a pilot participant is unable to successfully use the kiosk, CBP's backend Information Technology (IT) system automatically generates and sends an email to that participant. The email invites the participant to provide feedback and the details of his or her experience. CBP reviews this input and, whenever possible, responds to the participant with information about why the difficulty has occurred. CBP then uses this information to make operational improvements.

Regarding the part of one comment about some CBP officers not having the requisite knowledge to provide assistance to Global Entry participants, CBP is committed to the ongoing training and education of its personnel. As the pilot has expanded, CBP officers have become increasingly familiar with the procedures for processing Global Entry participants, which has, based on informal feedback received by CBP, led to improved participant satisfaction.

Comment: CBP received two comments suggesting that CBP should expand marketing and outreach for the program and include airports, airlines, and other entities in its outreach plans.

Response: CBP agrees that the marketing of Global Entry should be expanded, and CBP has begun that process. CBP has been engaged in public outreach to promote the Global Entry program and has started an extensive marketing campaign to increase Global Entry enrollment. CBP has enlisted the services of a marketing firm to assist in developing a marketing strategy. The firm has created a new Global Entry logo and tag line (“Trusted Traveler Network”). The marketing firm has also redesigned Global Entry brochures and is working with CBP to improve the layout of the program's Web site. CBP will increase public outreach efforts by placing advertisements in prominent and travel-related publications. The advertisements will outline the program's purpose, requirements, and benefits.

During the operation of the pilot, CBP has worked with airlines, airport operators, and other private sector companies and organizations to perform public outreach and will continue to do so. Promotion of Global Entry involves the use of various methods, such as advertisements, informational videos, and brochures, to increase awareness of the program and to encourage people to apply to join the program. One major airline published a Global Entry advertisement in its in-flight magazine. A major airport authority printed its own signs for Global Entry and strategically placed them throughout the airport. In addition, CBP has worked with the private sector by coordinating on-site enrollment events for various companies and trade shows.

Comment: Many of the commenters would like CBP to expand Global Entry. Several commenters praise CBP's efforts thus far to expand Global Entry participation through arrangements with foreign countries. Two commenters would like CBP to expand the program to more airports. One commenter stated that CBP should expand the program to include “private aircraft used for recreation purposes” similar to the current I-68 program for recreational boaters. Another commenter would like CBP to expand the program to include domestic flights. One commenter sets forth many ideas as to how the Global Entry program might be expanded and integrated with other programs, including expansion of eligibility to Mexican nationals. That commenter also welcomed CBP's ongoing efforts to expand Global Entry participation to qualified individuals from foreign countries. One commenter would like CBP to expand the program to include travelers from the United Kingdom. Another commenter would like CBP to expand Global Entry to include children under 14 so that families can take advantage of the program. Finally, the one commenter that responded to the notice announcing the expansion to Mexican nationals states that the expansion would be “too risky” and that “the addition would increase the risk greater than the benefit” but does not explain what risks are being referenced or offer any basis for the statements.

Response: CBP agrees with the majority of the commenters that the Global Entry pilot should be expanded.

While the Global Entry program will initially be limited to the twenty airports that comprised the Global Entry pilot, CBP intends to expand the Global Entry program to additional airports. When CBP is ready to expand to additional airports and has selected the airport or airports for expansion, this information will be announced to the public by Federal Register notice and on the Web site, www.globalentry.gov. In addition, once the final rule is published, CBP intends to expand the Global Entry program by adding more kiosks at airports where the Global Entry pilot is currently operational (subject to the availability of funds). This will accommodate new Global Entry participants as enrollment increases.

CBP is also open to the suggestion of making Global Entry available to passengers and crew on private (recreational) aircraft who are Global Entry participants. In fact, CBP has already installed a kiosk at one private aircraft terminal as part of the Global Entry pilot. A kiosk is currently operational at the General Aviation Facility (GAF) at the Ft. Lauderdale Hollywood International Airport. Pilot participants who are passengers or crew on private aircraft at Ft. Lauderdale Hollywood International Airport, and arrive at the GAF private aircraft terminal, can use the Global Entry kiosk operating at that terminal. CBP decided to make Global Entry available to private aircraft at the GAF at the Ft. Lauderdale Hollywood International Airport due to the large number of private aircraft, mostly recreational, that utilize that airport and terminal. The availability of the Global Entry program will continue at the Ft. Lauderdale Hollywood International Airport after the Global Entry pilot becomes an ongoing program under this final rule. As Global Entry progresses, CBP will determine whether it is feasible to expand the program to additional private aircraft locations. It should be noted that private aircraft must comply with all applicable reporting and inspection processes.

Regarding the comments asking CBP to expand Global Entry to persons from other countries, this final rule contains a provision to permit certain nonimmigrant aliens to participate in the program. Under the final rule, the government of a foreign country must enter into and operationalize a joint arrangement with CBP concerning the expedited entry of air travelers in order for travelers from that country to apply for and, if found eligible, participate in Global Entry. The final rule provides that CBP will announce such arrangements by publication in the Federal Register . Additionally, under these arrangements, active members of Global Entry may be eligible to apply for membership in the other foreign government's trusted traveler program. Where consistent with U.S. security requirements, CBP has worked, and will continue to work, with interested countries that operate comparable international trusted traveler programs, or have plans to operate such programs, to enter into arrangements for the purposes of expanding eligibility for Global Entry and making U.S. citizens eligible to join those countries' trusted traveler programs.

For example, under the Global Entry pilot, CBP has entered into an arrangement with the Netherlands to allow citizens of the Netherlands who participate in Privium, an expedited travel program operated by the Government of the Netherlands, to participate in the Global Entry pilot. Several commenters specifically applauded the arrangement with the Netherlands. This arrangement will continue under the Global Entry program. As with all other participants in the Global Entry pilot, currently participating citizens from the Netherlands will be automatically enrolled in Global Entry when Global Entry becomes an ongoing program.

CBP has also allowed Canadian and Mexican members of SENTRI and NEXUS to use Global Entry kiosks at pilot Ports of Entry. CBP will continue to allow SENTRI and NEXUS members to use this service when Global Entry becomes an ongoing program.

Recently, CBP has further expanded eligibility for joining the Global Entry pilot to include qualified Mexican nationals who otherwise satisfy the requirements for participation in the pilot. Mexican nationals may only utilize the Global Entry kiosks upon successful completion of a thorough risk assessment by CBP and the Mexican Government. Currently participating Mexican nationals will be automatically enrolled in Global Entry when Global Entry becomes an ongoing program.

CBP does not agree with the commenter who indicated that the expansion of Global Entry pilot to Mexican nationals is too risky. As noted above, Mexican nationals may only use the Global Entry kiosks upon successful completion of a thorough risk assessment by CBP and the Mexican Government. Moreover, no applicant is accepted for participation in Global Entry if CBP determines that the individual presents a potential risk for terrorism, criminality (such as smuggling) or if CBP cannot otherwise sufficiently determine that the applicant meets all the program eligibility criteria. CBP vets participants in Global Entry on a recurring basis and can suspend or terminate membership if derogatory information arises about an enrollee that makes him or her no longer eligible. In addition, if circumstances indicate that a country cannot meet its vetting or other obligations under its arrangement with CBP, CBP can modify, suspend, or discontinue the joint arrangement if necessary based on the arrangement's particular terms.

CBP will announce any further expansions of the Global Entry program (including adding airports, extending eligibility to additional populations, or expanding reciprocal eligibility for U.S. citizens to foreign governments' trusted traveler programs), as well as any retractions ( i.e., cancellations of such arrangements) by publication of a notice in the Federal Register .

CBP does not agree, at this time, with the commenter who suggested that Global Entry should be expanded to include domestic flights. Global Entry is designed to allow expedited screening and processing of pre-approved, low-risk international air travelers into the United States. CBP, in coordination with the Transportation Security Administration (TSA) and other stakeholders, remains open to developing proposals to apply the trusted traveler concept to domestic commercial aviation security.

With regard to the age limit, CBP has reconsidered and agrees that it would be beneficial to expand Global Entry to allow children under the age of 14 to participate, as this would allow more families to enjoy the benefits of the program. Persons under the age of 18 who meet the general eligibility criteria and have the consent of a parent or legal guardian will be eligible to participate in Global Entry. As is the case for all applicants, CBP must be able to conduct the requisite vetting of the applicant, including collection of the required fingerprints needed to conduct the biometric based background checks and participate in an interview at an enrollment center.

Comment: One commenter would like CBP to minimize the costs to airports and airlines.

Response: The infrastructure and daily operation costs of the Global Entry program are the responsibility of CBP. These costs have been, and will continue to be, funded by user fees. There are no direct costs to the airlines or airports. In fact, airport authorities and airlines benefit from their customers enrolled in Global Entry receiving an enhanced travel experience. Airlines also benefit from the expedited processing of their crew members who enroll in the program.

Comment: One commenter states that the Global Entry program may be vulnerable to forged documents, although no arguments are provided to support this comment.

Response: CBP disagrees with this comment. The Global Entry program includes many protections against forgery and fraud. Global Entry applications are submitted online and go directly to a central CBP vetting center. Then, if conditionally approved, the application moves forward to the enrollment center, where CBP addresses, among other things, any unresolved issues or potential derogatory information regarding the applicant. During the enrollment center interview, all of the information provided by an applicant is verified. An applicant's travel documents are physically examined by CBP officers to validate authenticity and identity. CBP can also validate documents against the Department of State and U.S. Citizenship and Immigration Services databases. The interconnectivity and automated nature of these processes result in operational efficiencies and a high-level of security surrounding personal information.

Comment: Two commenters suggested that CBP should ensure that there is adequate private sector involvement in the operation of Global Entry. They maintain that certain functions, such as enrollment, marketing, and customer service could be performed by the private sector.

Response: CBP considers many functions of Global Entry to be governmental due to privacy concerns and issues of national security. For example, as part of the enrollment process, CBP officers must review the citizenship or immigration status of Global Entry applicants to make sure that they are admissible under the complex admissibility requirements under the INA. Global Entry has successfully demonstrated the efficiencies of its current process in the pilot phase. The fact that applicants can deal directly with the government allows CBP to keep the Global Entry fee low.

As noted elsewhere in this document, CBP is currently working with, and will be increasing our collaboration with, several private entities in the marketing of Global Entry, including airlines, hotels, travel and tourism companies, national business travelers groups, major companies, airports, and marketing firms.

Comment: One commenter stated that “industry standards” should be utilized when operating a “self-service terminal environment” and attached to the comment a document said to describe these standards. The document attached to the comment pertained to Automated Teller Machines. This commenter states that CBP must be able to remotely support the terminals and to know when those terminals are available or are having component problems.

Response: CBP has operating procedures in place that are appropriate to the kiosks used in the Global Entry program. Under these procedures, when a kiosk (or terminal) encounters a problem or is not operational, the IT system automatically notifies CBP personnel to troubleshoot the problem. These protocols allow CBP to make modifications to individual terminals without disrupting the entire network.

One commenter addresses several privacy concerns that the commenter perceives to exist in the Global Entry Program and the Global Enrollment System (GES) that supports Global Entry and other CBP trusted traveler programs. We address these comments in turn:

Comment: The commenter states that the Global Entry Program contravenes the intent of the Privacy Act (5 U.S.C. 552a) through CBP's assertion of the exemptions found at sections (j)(2) and (k)(2) of the Privacy Act for information retained in the GES. (Section (j)(2) allows the head of any agency to exempt from certain sections of the Privacy Act any system of records that is maintained by an agency or component with a principal function of law enforcement; section (k)(2) allows an agency head, to a limited extent, to exempt from certain sections of the Privacy Act investigatory material compiled for law enforcement purposes.)

Response: CBP disagrees with this comment. Exempt information in GES is limited to information derived from law enforcement databases or investigative files. The exemption statement for the GES System of Records Notice clearly states that no exemption will be claimed for information obtained from an application or otherwise submitted by an applicant.

The exemptions found at (j)(2) and (k)(2) are asserted to protect information compiled from background checks performed to assist CBP in determining whether to approve a trusted traveler application. The purpose of a decision to approve an applicant for a trusted traveler program, including Global Entry, is to allow for expedited clearance ( i.e., to permit pre-approved, low risk travelers to obtain admission to the United States more quickly) in circumstances where the person seeking admission has volunteered and met the program's eligibility requirements. CBP, consistent with its border security and trade facilitation missions, performs a law enforcement background check prior to making a decision to approve or deny a trusted traveler application. These background checks include information obtained from law enforcement databases and investigative files and may contain information relating to criminal or civil violations. Consistent with the Privacy Act, CBP asserts these exemptions on a case- by-case basis where access to a responsive record is sought.

Comment: The commenter states that the Global Entry applicant is afforded only limited Privacy Act protections as the exemptions for GES create the potential for CBP to “use the information with little accountability.”

Response: CBP disagrees with this comment. Exempt information in GES is limited to information derived from law enforcement databases or investigative files. Each request for access to exempt information will be reviewed on a case-by-case basis. After conferring with the appropriate component or agency, CBP may waive applicable exemptions in circumstances where it would not interfere with or adversely affect the law enforcement purposes of the systems from which the information is either recompiled or contained. Information submitted by or on behalf of the applicant as part of her or his application may be sought pursuant to the Privacy Act or Freedom of Information Act.

Additionally, the applicant may seek redress through the several avenues provided in the Global Entry program including at the enrollment center where that individual's interview was conducted, the DHS Traveler Redress Inquiry Program (DHS TRIP), or the CBP Trusted Traveler Ombudsman to address concerns or agency actions to which they attribute CBP reliance upon information that they believe to be erroneous or to have an inappropriately derogatory affect upon CBP's decision concerning their participation in the program.

Comment: The commenter states that the Global Entry program creates a significant security risk as the applicant's personally identifiable information (PII), including biometric data and employment history, in GES may be disclosed to any government agency beyond the “routine use” provisions of the Privacy Act.

Response: CBP disagrees with this comment. CBP abides by the requirements of the Privacy Act in determining whether to share information derived from GES, pursuant to a routine use. CBP takes reasonable measures to ensure that information that is shared consistent with its authority is appropriately protected. Before any information is disclosed, CBP considers whether the disclosure and use of the data are consistent with the purpose for collection and are consistent with the terms of a statutory or published routine use.

Comment: The commenter states that CBP failed to publish a Privacy Impact Assessment (PIA) for Global Entry.

Response: CBP disagrees with this comment. Global Entry, as a trusted traveler program, is included and covered by the PIA for the GES published on April 20, 2006. While the GES PIA refers to Global Entry under its former name (USPASS/International Registered Traveler (IRT)), the particulars of the program, its collection of information, the system in which it maintains that information, and the uses to be made of the information, are described within that document.

Comment: The commenter states that the lessons learned from a previous Government agency-operated registered traveler program weigh against the establishment of the Global Entry program.

Response: CBP disagrees with this comment. The comment refers to a registered traveler concept that the Government originally tested but was later transferred to the private sector. In certain cases, the private entities that captured and maintained biographic and biometric data allegedly failed to secure PII in their own databases that were not connected to, and did not interact with, Government systems. In contrast, the Global Entry program has sufficient systems and safeguards in place to ensure the security and privacy of the individuals' records. CBP and its predecessor agencies, the Immigration and Naturalization Service and the United States Customs Service, have many years experience successfully operating and protecting PII for trusted traveler programs such as NEXUS, SENTRI, and FAST.

After consideration of the comments received, and based on the success of the Global Entry pilot, CBP has determined that Global Entry should be established as an ongoing program. The Global Entry program, like the Global Entry pilot, will facilitate the movement of pre-approved, low-risk air travelers arriving in the United States. The Global Entry program will provide an expedited inspection and examination process for pre-approved, low-risk air travelers by allowing them to proceed directly to automated Global Entry kiosks upon their arrival in the United States at Global Entry-equipped Ports of Entry. This ongoing Global Entry program, along with the other trusted traveler programs that CBP operates, is consistent with CBP's strategic goal of facilitating legitimate travel while securing the homeland.

Accordingly, this final rule adopts, with the changes described in Section III B, the ongoing Global Entry program as proposed in the NPRM. Current participants in the Global Entry pilot, including those citizens of the Netherlands and Mexican nationals who participate through joint arrangements with those countries, will be automatically enrolled in the Global Entry program for five years from the date of their initial enrollment in the pilot. Participation in Global Entry will remain voluntary and subject to the enrollee continuing to satisfy the program's entry requirements. The existing Global Entry pilot will continue to operate until the effective date of this final rule.

CBP anticipates that the Global Entry program eventually will be expanded to operate at most major international airport locations within the United States. The program, however, initially will be limited to the twenty airports that have participated in the Global Entry pilot. The airports chosen for Global Entry are those facilities which typically experience the largest numbers of travelers arriving from outside of the United States.

The Global Entry pilot currently operates at the following twenty airports: John F. Kennedy International Airport, Jamaica, New York (JFK); George Bush Intercontinental Airport, Houston, Texas (IAH); Washington Dulles International Airport, Sterling, Virginia (IAD); Los Angeles International Airport, Los Angeles, California (LAX); Hartsfield-Jackson Atlanta International Airport, Atlanta, Georgia (ATL); Chicago O'Hare International Airport, Chicago, Illinois (ORD); Miami International Airport, Miami, Florida (MIA); Newark Liberty International Airport, Newark, New Jersey (EWR); San Francisco International Airport, San Francisco, California (SFO); Orlando International Airport, Orlando, Florida (MCO); Detroit Metropolitan Wayne County Airport, Romulus, Michigan (DTW); Dallas Fort Worth International Airport, Dallas, Texas (DFW); Honolulu International Airport, Honolulu, Hawaii (HNL); Boston—Logan International Airport, Boston, Massachusetts (BOS); Las Vegas—McCarran International Airport, Las Vegas, Nevada (LAS); Sanford—Orlando International Airport, Sanford, Florida (SFB); Seattle—Tacoma International Airport-SEATAC, Seattle, Washington (SEA); Philadelphia International Airport, Philadelphia, Pennsylvania (PHL); San Juan—Luis Munos Marin International Airport, San Juan, Puerto Rico (SJU); and Ft. Lauderdale Hollywood International Airport, Fort Lauderdale, Florida (FLL). A Global Entry kiosk is also available at the private aircraft terminal, General Aviation Facility (GAF), at Fort Lauderdale Hollywood International Airport. This final rule serves notice that, upon the effective date of the Global Entry program, the program will continue to operate at these same 20 airports and at the private aircraft terminal, GAF, at Fort Lauderdale Hollywood International Airport.

CBP will announce expansions to new airports in a Federal Register notice and on the Web site www.globalentry.gov, just as CBP has announced them for the pilot. An updated list of all the airports at which Global Entry is operational will be available at www.globalentry.gov.

The United States has entered into an arrangement with the Netherlands concerning Global Entry. Pursuant to this arrangement, qualified citizens of the Netherlands who participate in Privium, an expedited travel program in the Netherlands, may apply for participation in the Global Entry program. Applicants who are citizens of the Netherlands will be required to complete the Global Entry on-line application, pay the non-refundable $100 applicant processing fee, and satisfy all the requirements of the Global Entry program. Based on the terms of the existing arrangement with the Government of the Netherlands, these citizens will be permitted to participate in Global Entry only upon successful completion of a thorough risk assessment by both CBP and the Government of the Netherlands.

CBP is currently accepting applications from eligible citizens of the Netherlands for the Global Entry pilot and will continue to accept such applications as Global Entry becomes an ongoing program. This final rule also serves notice that, upon its implementation, citizens of the Netherlands who are existing participants in the Global Entry pilot will be automatically enrolled in the Global Entry program. The time period of their enrollment will be five years beginning from the date of their enrollment in the pilot.

The Netherlands is also a participant in the Visa Waiver Program (VWP). The VWP enables citizens and nationals from participating countries to travel to and enter the United States for business or pleasure purposes for up to 90 days without obtaining a visa. VWP travelers are required to obtain a travel authorization via the Electronic System for Travel Authorization (ESTA) prior to traveling to the United States under the VWP. ESTA is accessible online at https://esta.cbp.dhs.gov. The ESTA requirements will continue to be applicable to Global Entry applicants who are VWP travelers. Global Entry applicants from the Netherlands who wish to travel to the United States under the VWP must have an approved ESTA when applying for Global Entry. CBP will explore ways to integrate the ESTA process with the Global Entry application process.

Pursuant to the arrangement with the Government of the Netherlands, U.S. citizens who participate in Global Entry will have the option to also apply to join Privium. Privium is an automated border passage system in the Netherlands that provides expedited entry and exit at Amsterdam Airport Schiphol. It uses iris scans to provide quick and secure biometric confirmation of a traveler's identity. Enrollment includes an eligibility assessment by the Dutch border police. Upon a positive determination of eligibility, pictures of each iris are taken and stored on a personalized smart card. Upon entry and exit, Privium members place their Privium smart card into a reader and a passport validity check is performed with the Dutch authorities and valid membership is verified. The individual's iris information is then compared against the iris information stored on the card. This border passage process takes approximately twelve seconds.

Additional fees and information sharing beyond CBP's Global Entry requirements are needed for U.S. citizens who wish to participate in Privium through Global Entry. If approved, U.S. citizens would be able to take advantage of expedited travel into, and out of, the Netherlands at Amsterdam Airport Schiphol. More information about how to apply for Privium membership is available at www.globalentry.gov.

DHS, through CBP, has issued a Joint Declaration with the Secretariat of Governance of the United Mexican States, through the National Migration Institute, concerning Global Entry. Pursuant to this Joint Declaration, qualified Mexican nationals may apply to join the Global Entry program. Mexican nationals will be required to complete the on-line application, pay the non-refundable $100 per person applicant processing fee, and satisfy all the requirements of the Global Entry program. Based on the terms of the Joint Declaration, Mexican nationals will be permitted to use the Global Entry kiosks only upon successful completion of a thorough risk assessment by both CBP and the Mexican Government.

CBP is currently accepting applications from eligible Mexican nationals for the Global Entry pilot and will continue to accept such applications as Global Entry becomes an ongoing program. This final rule serves notice that upon its implementation, Mexican nationals who are existing participants in the Global Entry pilot will be automatically enrolled in the ongoing Global Entry program. The time period of their enrollment will be five years, beginning from the date of their enrollment in the pilot.

DHS, through CBP, has issued a Joint Declaration with the Secretariat of Governance of the United Mexican States, through the National Migration Institute, concerning Global Entry. Pursuant to this Joint Declaration, U.S. citizens who participate in the Global Entry program will have the option to apply for participation in Mexico's trusted traveler program, once such a program is developed.

Members in good standing of NEXUS and SENTRI are permitted to use Global Entry kiosks as part of their NEXUS or SENTRI membership. NEXUS is a program jointly administered by the United States and Canada that allows certain pre-approved, low-risk travelers expedited processing for travel between the United States and Canada. The SENTRI trusted traveler program allows certain pre-approved, low-risk travelers expedited entry at specified land border ports along the U.S.-Mexico border.

Expansion of the Global Entry Program achieved through arrangements with other countries will be announced by publication of a notice in the Federal Register and on the Web site www.globalentry.gov. If any arrangements with other countries under the pilot are announced in the Federal Register before this rule becomes effective, those arrangements will continue after this rule becomes effective. CBP may modify, suspend, or discontinue arrangements made with other countries for participation in Global Entry without prior notice to the public, but will announce such actions, as soon as practicable, by publication of a notice in the Federal Register and on the Web site www.globalentry.gov.

Based on experiences with the Global Entry pilot and comments from the public, CBP has made the following minor changes from the proposed regulations in order to provide CBP with optimal flexibility in future operations of Global Entry and to allow for the integration of new technologies:

Proposed section 235.7a is designated in the final rule as section 235.12. Proposed section 235.7a (b) (“Definitions”) is removed. We have determined that the definitions are unnecessary as the terms that were defined (nonimmigrant alien, U.S. citizen, U.S. lawful permanent resident, and U.S. national) are understood to have the same meaning that they have throughout Title 8 of the Code of Federal Regulations (8 CFR) and as defined and/or described by statute in 8 U.S.C. 1101. Should any of these definitions be changed by statute or regulation, conforming changes to the Global Entry regulations would not be required. The letter designations of the remaining sections are changed accordingly.

At new section 235.12(b)(1)(ii), regarding eligible individuals from countries that have entered into arrangements with CBP, we have deleted the word “reciprocal.” Although individuals belonging to the Global Entry program and a similar program operated by a country with which CBP has entered such an arrangement will receive some “reciprocal” benefits from both countries, the memberships will not be completely reciprocal since each country must separately approve applicants. Therefore, an applicant could be accepted into one country's program but not that of the other country participating in the arrangement. The specific arrangements and the terms and conditions of arrangements will vary and will be announced in the Federal Register .

At new section 235.12(b)(1)(iii), regarding eligibility criteria, all references to the age limit of 14 are removed. This change will allow more families to enjoy the benefits of the program. Persons under the age of 18 who meet the general eligibility criteria and have the consent of a parent or legal guardian will be eligible to participate in Global Entry.

At new sections 235.12(b)(1) and 235.12(f), regarding program eligibility criteria and the required travel documents for Global Entry participants, we have added the words “or other appropriate travel document as determined by CBP.” These two sections designate the types of “machine-readable” documents that Global Entry participants will need for participation in Global Entry to enable the participant to use the kiosk. Due to rapidly changing technologies, it is possible that alternative documents would be appropriate for this purpose. This change will allow for such future development.

At new section 235.12(d) regarding program application, we are revising the language to allow for possible new technologies (changes in software). Specifically, we are removing references to the Global On-line Enrollment System (GOES) as the described method of applying for Global Entry. Although CBP currently uses GOES to process Global Entry applications, the removal of the specific reference to GOES would allow for future process or system changes.

At the new section 235.12(d)(3), we added a sentence to clarify that every applicant accepted into Global Entry is accepted for a period of 5 years provided participation is not suspended or terminated by CBP prior to the end of the 5-year period. In order to provide greater flexibility for the public in the renewal process, we have increased the time period in which the public may apply to renew participation from up to 90 days before expiration to up to one year before expiration. In addition, for consistency with other sections, we have changed “membership period” to “participation period”.

At new section 235.12(e), regarding interview and enrollment, we have removed the language indicating that the applicant will schedule his or her interview through their GOES account and will be notified of his or her acceptance or denial also through the GOES account. This will provide CBP with flexibility in developing alternative or different procedures to accomplish these tasks in the future. Presently, applicants will schedule their interviews and receive notification of acceptance or denial through their GOES account. These procedures will continue until such time that CBP develops alternate methods to accomplish these tasks.

Section 508 of the Rehabilitation Act of 1973 requires federal departments and agencies to ensure that the information and communication technology (ICT) that they procure, develop, maintain, or use is accessible to participants with disabilities. Participants in Global Entry will use an automated kiosk to expedite their admission to the United States. The Global Entry kiosks have been designed to meet all applicable Section 508, Subpart B Technical Standards: section 1194.25 standards for Self-Contained Closed Products. These specific Section 508 standards apply to self-contained, closed products, such as automated kiosks, and require that the access features of the kiosk be built into the system so users do not have to attach an assistive device. Additional specifications address mechanisms for private listening such as a headset or a standard headphone jack, touchscreens, auditory output, adjustable volume controls and requirements that the location of the kiosk controls is in accessible reach ranges. The Global Entry automated kiosks are Section 508-compliant. 1 Global Entry participants must provide fingerprint biometrics at the time of the personal interview and again at the kiosk at the airport. CBP has also made the kiosks and the Global Entry program accessible to participants with disabilities related to the collection of biometrics. If an applicant is missing a digit(s), the CBP officer will make the proper annotation in the system to allow such an individual to use the Global Entry kiosk.

This rule is not an “economically significant” rulemaking action under Executive Order 12866, as supplemented by Executive Order 13563, because it will not result in the expenditure of more than $100 million in any one year. This rule, however, is a significant regulatory action under Executive Order 12866; therefore, this rule has been reviewed by the Office of Management and Budget.

Global Entry is a voluntary program that speeds the CBP processing time for participating air travelers by more than 70%. Travelers who are otherwise admissible to the United States will be able to enter or exit the country regardless of whether they participate in Global Entry. This evaluation explores the potential costs and benefits of this voluntary trusted traveler program.

CBP estimates that over a 5-year period Global Entry will process approximately 500,000 enrollees, equating to an annual average of 100,000 individuals. Note that this estimate is twice the number of individuals estimated in the NPRM. Since publication of the NPRM, CBP has embarked on a wide outreach campaign to inform the public about the program. The Global Entry program has thus been well advertised and well received by the traveling public, and enrollment numbers have increased far beyond original expectations. To account for this success, CBP now estimates an annual average of 100,000 individuals. CBP will charge a fee of $100 per applicant and estimates that each application will require 40 minutes (0.67 hours) of the potential enrollee's time to search existing data resources, gather the data needed, and complete and review the application form. Additionally, an enrollee will experience an “opportunity cost of time” to travel to an enrollment center upon acceptance of the initial application. We assume that 1 hour will be required for this time spent at the enrollment center and travel to and from the Center, though we note that during the pilot, many applicants have coordinated their trip to an enrollment center with their travel at the airport. We have used 1 hour of travel time so as not to underestimate potential opportunity costs for enrolling in the program. We use a value of $44.30 for the opportunity cost for this time, which is taken from the Department of Transportation's Revised Departmental Guidance on Valuation of Travel Time in Economic Analysis (September 28, 2011. See Table 4. Available at http://www.faa.gov/regulations_policies/policy_guidance/benefit_cost, accessed November 1, 2011). This value is the weighted average for U.S. business and leisure travelers.

Using these values, we estimate that the cost per enrollee is $173.98 ($44.30 per hour × 1.67 hours + $100 enrollment fee). If there are 100,000 enrollees annually, this cost will be $17.4 million per year. Over 5 years, the total costs to enrollees will be approximately $76 million at a 7 percent discount rate ($82 million at a 3 percent discount rate).

As noted previously, Global Entry will allow for expedited processing for those travelers enrolled in the program. Based on an analysis from a year-long study (June 2008 to June 2009), DHS estimates enrollees could save more than 70% in processing time with an average savings of 7.6 minutes per trip (standard deviation of 3.8 minutes). In addition, more than 50 percent of Global Entry passengers were admitted into the United States in one minute or less and 82 percent were admitted into the United States in less than five minutes; ( see U.S. Department of Homeland Security Customs and Border Protection and U.S. Department of Homeland Security, Office of Policy. March 2010. “Global Entry Twelve Month Pilot Review: From June 6, 2008 to June 6, 2009.” Page 4. This document is available for review in the public docket for this rulemaking). Monetizing time savings is difficult; entry processing times vary widely among airports and times of day (note the large standard deviation above), and the number of trips that Global Entry will be used for any given individual is unknown. During some peak periods at some international airports, entry processing times can be an hour or more. Avoiding such lines by using Global Entry kiosks and avoiding all other entry processing would likely represent a clear savings in time for a typical participant.

Because participation in the Global Entry program is voluntary, the perceived benefits of reduced wait time would have to equal or exceed the cost of the program over 5 years. Potential enrollees will determine whether or not it is worthwhile to enroll in the program based on their individual preferences, which will be influenced by the number of trips they make and the typical wait times they experience when entering the United States. The most likely participants in the program are those that plan to make multiple trips over 5 years from participating airports, typically experience long waits at the airports they use, or are averse to the perceived annoyance or inconvenience of standing in line for entry processing. Using the estimates presented above, if the annualized cost of the program is $42 (total cost of $173.98 amortized over 5 years at a 7 percent discount rate) and if the time saved per trip were 7.6 minutes (monetized savings of $5.61 per trip), then an average enrollee would need to make about eight trips annually through participating airports to consider enrollment in the Global Entry program worth the cost and estimated burden.

In addition to travelers who enroll in the program, those travelers not enrolled in Global Entry could experience a small time-savings as well. If Global Entry enrollees are not standing in the regular entry processing lines, non- enrollees could experience reduced wait times.

Faster processing of all travelers leads to fewer missed connections and more satisfied customers. Because of the benefits the program provides, many airports and airlines have expressed to CBP their strong support of Global Entry. Likewise, trade associations have expressed their support of the program, saying that it enhances security while easing the flow of international commerce. Because of the benefits, airlines, airports, and trade associations have voluntarily promoted Global Entry to their customers through email, pamphlets, and web advertisements.

Finally, the costs for CBP to administer this program are not included here because they will be recovered through the $100 enrollment fee. CBP could experience benefits by speeding passenger processing and avoiding time needed to process proven low-risk travelers. The time saved would allow CBP to focus more attention on higher-risk travelers, which would improve security.

This section examines the impact of the rule on small entities as required by the Regulatory Flexibility Act (5 U.S.C. 604), as amended by the Small Business Regulatory Enforcement and Fairness Act of 1996. A small entity may be a small business (defined as any independently owned and operated business not dominant in its field that qualifies as a small business per the Small Business Act); a small not-for-profit organization; or a small governmental jurisdiction (locality with fewer than 50,000 people).

CBP has considered the impact of this rule on small entities. Global Entry is voluntary and the fee to enroll in Global Entry is one hundred dollars plus the opportunity cost of the individual applying. CBP believes such an expense would not rise to the level of being a “significant economic impact,” particularly as the expense need not be incurred unless the enrollee chooses to incur it. CBP did not receive any comments during the public comment period regarding impacts to small entities. Thus, CBP certifies that this rule will not have a significant economic impact on a substantial number of small entities.

This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions are necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

The rule will not have substantial direct effects 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. Therefore, in accordance with section 6 of Executive Order 13132, this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.

Information is being collected from voluntary applicants in order to assess whether the individuals meet the eligibility requirements and are otherwise deemed to be low-risk travelers and therefore may appropriately participate in the voluntary Global Entry program. This information will be collected through GOES. This collection of information is required and authorized by 8 U.S.C. 1365b and 8 CFR part 235 for use in international trusted traveler programs. Additionally, the information being collected is necessary to satisfy the requirements regarding examination of aliens applying for admission to the United States pursuant to 8 U.S.C. 1225(a)(3), 8 U.S.C. 1225(b) and 8 U.S.C. 1182(a)(7), and U.S. Citizens entering the United States pursuant to 8 U.S.C. 1185(b).

An agency may not conduct, and a person is not required to respond to, a collection of information unless the collection of information displays a valid control number assigned by OMB. CBP has submitted a revision to OMB clearance 1651-0121 to reflect the addition of the Global Entry Program in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507).

The burden estimates for collecting and entering information for the GOES on-line application for Global Entry, interview time, and travel time are presented below:

Estimated Number of Respondents: 100,000.

Estimated Number of Responses per Respondent: 1.

Estimated Number of Total Annual Responses: 100,000.

Estimated Time per Response: 1 hour and 40 minutes (1.67 hours).

Estimate Total Annual Burden Hours: 167,000.

The estimated total fee cost to respondents resulting from the $100 enrollment fee for Global Entry is $10 million.

The on-line application for Global Entry, currently known as GOES, collects information similar to that collected on applications for CBP's other trusted traveler programs ( i.e., NEXUS, SENTRI and FAST). The information collected through the on-line application is deposited into the Global Enrollment System (GES), as the system of record for CBP trusted traveler programs. The personal information provided by the applicants, including the fingerprint biometrics taken at the time of the personal interview, may be shared with other government and law enforcement agencies in accordance with applicable laws and regulations. The personal information that is collected through GOES is maintained in a Privacy Act system of records (GES) for which the required notice was last published in the Federal Register (71 FR 20708) on April 21, 2006. Additionally, CBP published a PIA for GES on April 20, 2006 that covers this program on the DHS Privacy Office Web site, www.dhs.gov/privacy. In addition, a PIA update addressing the on-line functionality of the enrollment process (GOES) was posted to the DHS Privacy Office Web site on November 1, 2006. Applicant biometrics (fingerprints, photographs) are stored in the DHS Automated Biometric Identification System (IDENT). The IDENT Privacy Act System of Records notice was last published on June 5, 2007.

The signing authority for this document falls under 8 U.S.C. 1365b(k) pertaining to the authority of the Secretary of Homeland Security to develop and implement a trusted traveler program to expedite the travel of previously screened and known travelers across the borders of the United States.

History

Class C airspace areas are designed to improve air safety by reducing the risk of midair collisions in high volume airport terminal areas and to enhance the management of air traffic operations in that area. The FAA Central Service Center recently completed its biennial evaluation of existing Class C airspace areas in the Central Service Area and determined three Class C airspace areas required description amendments to match the FAA's aeronautical database. Specifically, this amendment corrects the airport names for Springfield, MO; Lincoln, NE; and Grand Rapids, MI, and makes minor adjustments to the ARP geographic position information for Springfield, MO, and Grand Rapids, MI.

This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 by amending Class C airspace at Springfield, MO; Lincoln, NE; and Grand Rapids, MI. The airport formerly known as Springfield-Branson Regional Airport in Springfield, MO, is renamed Springfield-Branson National Airport. The airport formerly known as Lincoln Municipal Airport in Lincoln, NE., is renamed Lincoln Airport. The airport formerly known as Grand Rapids Kent County International Airport in Grand Rapids, MI, is renamed Gerald R. Ford International Airport. Additionally, the ARP geographic position for the Springfield-Branson National Airport is changed from lat. 37°14′40″ N., long. 93°23′13″ W. to lat. 37°14′44″ N., long. 93°23′19″ W., and the ARP geographic position for the Gerald R. Ford International Airport is changed from lat. 42°52′57″ N., long. 85°31′26″ W. to lat. 42°52′51″ N., long. 85°31′22″ W. These minor adjustments to the geographic coordinates reflect the current information in the FAA's aeronautical database.

There are no changes to routing or air traffic control procedures resulting from this action. Accordingly, since this is an administrative change and does not affect the boundaries, altitudes, or operating requirements of the airspace, notice and public procedures under Title 5 U.S.C. 553(b) are unnecessary.

Class C airspace areas are published in paragraph 4000 of FAA Order 7400.9V, dated August 9, 2011 and effective September 15, 2011, which is incorporated by reference in 14 CFR 71.1. The Class C airspace area amendment in this document will be published subsequently in the Order.

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. Therefore, this regulation: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (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. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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.

This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends the descriptions of the Class C airspace areas established in the vicinity of Springfield, MO, Lincoln, NE, and Grand Rapids, MI.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures,” paragraph 311a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

This rule amends Title 14 of the Code of Federal Regulations, part 97 (14 CFR part 97), by establishing, amending, suspending, or revoking SIAPS, Takeoff Minimums and/or ODPS. The complete regulators description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA Forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when required by an entry on 8260-15A.

The large number of SIAPs, Takeoff Minimums and ODPs, in addition to their complex nature and the need for a special format make publication in the Federal Register expensive and impractical. Furthermore, airmen do not use the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead refer to their depiction on charts printed by publishers of aeronautical materials. The advantages of incorporation by reference are realized and publication of the complete description of each SIAP, Takeoff Minimums and ODP listed on FAA forms is unnecessary. This amendment provides the affected CFR sections and specifies the types of SIAPs and the effective dates of the, associated Takeoff Minimums and ODPs. This amendment also identifies the airport and its location, the procedure, and the amendment number.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as contained in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts. The circumstances which created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPS and Takeoff Minimums and ODPS, an effective date at least 30 days after publication is provided.

Further, the SIAPs and Takeoff Minimums and ODPS contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPS and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. 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 procedures before adopting these SIAPS, Takeoff Minimums and ODPs are impracticable and contrary to the public interest and, where applicable, that good cause exists for making some 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 establishing, amending, suspending, or revoking Standard Instrument Approach Procedures and/or Takeoff Minimums and/or Obstacle Departure Procedures effective at 0902 UTC on the dates specified, as follows:

In the Federal Register of December 28, 2007 (72 FR 73589), FDA issued an interim final rule entitled “Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile” (hereinafter referred to as the interim final rule). 1 This rule became effective upon the date of publication in the Federal Register.

We issued the interim final rule to facilitate the safety, effectiveness, and availability of appropriate medical countermeasures stored in the SNS in the event of a public health emergency. We also recognized that it may be appropriate for certain human drugs, biological products, or medical devices (hereinafter referred to collectively as medical products) that are or will be held in the SNS to be labeled in a manner that would not comply with certain FDA labeling requirements. However, noncompliance with these labeling requirements could render such products misbranded under section 502 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 352). Under this rule, the appropriate FDA Center Director may grant exceptions or alternatives to certain regulatory labeling requirements applicable to medical products that are or will be included in the SNS if he or she determines that compliance with the labeling requirements could adversely affect the safety, effectiveness, or availability of specified lots, batches, or other units of medical products that are or will be included in the SNS. An exception or alternative granted under this rule may include conditions or safeguards deemed appropriate by the FDA Center Director to ensure that the labeling for such products includes information necessary for the safe and effective use of the product given the product's anticipated circumstances of use.

For example, this rule applies to certain medical products that enter the SNS as investigational products in addition to medical products in the SNS that are approved, licensed, or cleared for marketing. 2 Labels on investigational products ordinarily would not contain all elements required on licensed, approved, or cleared product labels. Certain information, such as expiration dates, warnings for users, license numbers of manufacturers and other information, may not be available or finalized for an investigational product, and thus could not be included on a container label if the investigational product was added to the SNS. Prior to the implementation of this rule, when investigational products were ultimately approved for marketing, the products would have been returned to the manufacturer or sent to relabelers for relabeling, a potentially time-consuming, costly, and labor-intensive process. Further, requiring relabeling of such investigational products after approval, licensure or clearance could adversely affect the safety, effectiveness, or availability of the products. This rule allows the appropriate FDA Center Director to grant an exception or alternative to the relevant labeling requirements to enable the immediate use of a product in the event of a public health emergency.

For these reasons, as explained in the interim final rule and the following section of this document, this rule allows FDA Center Directors to grant exceptions or alternatives to certain labeling requirements not explicitly required by statute for medical products that are or will be included in the SNS.

We received 7 comments on the proposed rule. These comments were received from hospitals, biologics manufacturers, law firms, other government agencies, and other interested persons. To make it easier to identify comments and our responses, the word “Comment,” in parentheses, will appear before the comment's description, and the word “Response,” in parentheses, will appear before our response. We have also numbered each comment to help distinguish between different comments. The number assigned to each comment is purely for organizational purposes and does not signify the comment's value or importance or the order in which it was received. Certain comments were grouped together because the subject matter of the comments was similar.

(Comment 1) One comment applauded the efforts put forth by the Agency to provide industry with the opportunity for exceptions or alternatives to FDA labeling requirements for products held by the SNS. The comment also recognized the importance of facilitating rapid access to large quantities of medical products in the event of an act of terrorism or natural disaster. Another comment expressed general agreement with the interim final rule.

(Response) We appreciate these comments in support of the rule. Congress mandated the development of a SNS to provide for the emergency health security of the United States in the event of a bioterrorist attack or other public health emergency (section 319F-2(a) of the Public Health Service Act (the PHS Act) (42 U.S.C. 247d-6(b))). By providing a legal mechanism for addressing certain labeling issues associated with medical products in the SNS without compromising their safety, effectiveness, or availability for use in an emergency, this rule is designed to help enable the rapid deployment of medical countermeasures stored in the SNS in the event of such an emergency.

(Comment 2) A number of comments responded to FDA's solicitation for comments as to whether the scope of the rule should be amended to include medical products in other Federal, State, and local stockpiles. One comment suggested that FDA expand the rule to include medical products stored in hospitals. Another comment suggested that the interim final rule should be extended to medical products stored in the Department of Defense stockpiles. Yet another comment requested that the scope of the rule not be extended to medical products in other Federal, State, or local stockpiles because extending the scope of the rule would most likely result in manufacturers seeing a high influx of requests for exceptions or alternatives to labeling requirements under the rule. Finally, a comment expressed general concern that the interim final rule is flawed and therefore should not be extended to other stockpiles.

(Response) We appreciate the comments received in response to our solicitation. We have considered the issue, including the points raised in these comments, and have decided not to extend the rule to other Federal, State, and local stockpiles. With respect to the comment that the scope of the rule should be extended to medications stored in hospitals, we note that the SNS was created by statute to maintain medical products under centralized control. Centralized control of the stockpile assures that appropriate products are selected for inclusion in the SNS and that they are then stored under appropriate conditions. Centralized control also provides for efficient distribution in the event of a public health emergency.

In response to the comment expressing concern that extending the rule to include additional medical products in other Federal, State, or local stockpiles would cause a high influx of requests for exceptions or alternatives to the labeling requirements specified in the rule, we recognize that extending the rule to other stockpiles may result in a high influx of requests and further note our concern that such requests would relate to products outside the control of SNS oversight. We reiterate that medical products are stockpiled in the SNS under centralized control to provide for efficient distribution in the event of a bioterrorist attack or other public health emergency, and this centralized control helps ensure that adequate procedures are followed for inventory management and accounting, and for the physical security of the stockpile. Accordingly, at this time, we decline to expand the scope of the final rule to apply to medical products in other Federal, State, and local stockpiles. Additionally, we note our disagreement with the comment that the interim final rule is generally flawed. As mandated by Congress, the SNS was created to provide for the emergency health security of the United States in the event of a public health emergency such as a bioterrorist attack. The interim final rule is necessary to give FDA Center Directors the ability to grant exceptions or alternatives to certain regulatory labeling requirements that could adversely affect the safety, effectiveness, or availability of medical products that are or will be included in the SNS in the event of a public health emergency.

(Comment 3) There were two comments regarding those provisions of the interim final rule which allow SNS officials, or any entity that manufactures (including labeling, packing, repackaging, or relabeling), distributes, or stores the medical products to submit a request for an exception or alternative to the labeling requirements specified in the rule. One comment expressed concern that the rule permitted a SNS official to apply for alternative labeling without the consent of the product license holder. The comment acknowledged that there may be situations that could require a SNS official to apply for a labeling change without the license holder's consent, such as if a license holder went out of business, but stated that in all other cases only the product license holder (or, in the case of an investigational product, the anticipated biologics license application (BLA) or new drug application (NDA) holder) should be permitted to request an exception or alternative to the labeling requirements specified in the rule. The comment further suggested that any request by a SNS official for an exception or alternative to the labeling requirements specified in the rule should be accompanied by the written concurrence of the product license holder.

Similarly, another comment requested that the rule be amended to allow only the product license holder or the sponsor of the investigational new drug application (IND) to submit a request for a labeling exception or alternative. The comment further requested that the rule be amended to require SNS officials to first submit a request for an alternative or exception to the labeling requirements specified in the rule to the product license holder or IND sponsor for its concurrence prior to submitting the request to FDA, and that the license holder or IND sponsor be required to concur with the request prior to SNS officials forwarding the request to FDA.

(Response) The interim final rule allows for drug, biologic, and device application holders, or sponsors of INDs or investigational device exemptions (IDEs), to submit requests for labeling exceptions or alternatives. Our experience to date with respect to the interim final rule has been that BLA holders or applicants or sponsors of INDs have submitted all of the requests received for labeling exceptions or alternatives with the concurrence of SNS officials. We continue to anticipate that many, if not all, of the requests submitted under this rule will be submitted by manufacturers with the concurrence of SNS officials prior to or at the time a specified lot, batch, or other unit of the product is procured by the SNS, or when an investigational product held in the SNS has been approved, licensed, or cleared. Nonetheless, we also continue to recognize the need for additional flexibility regarding products stored in the SNS to ensure their availability in the event of a public health emergency. For example, in order to prepare for an emergency, an SNS official or FDA Center Director could determine there is a need for labeling exceptions or alternatives to facilitate the use of a medical countermeasure during an emergency. We note that in this example we anticipate that the exception or alternative required would not result in any actual change to the product labeling, but rather would allow for the use of the product regardless of the current labeling.

Thus, we continue to recognize that it may be necessary to allow government officials, as well as any entity that manufactures (including labeling, packing, repackaging, or relabeling), distributes, or stores the medical product, to request exceptions or alternatives to the labeling requirements specified in this rule to ensure that medical products stored in the SNS are rapidly available for public use.

(Comment 4) A comment suggested that FDA grant or deny a request for an exception or alternative within 30 days from the receipt of any request because such situations may call for rapid turnaround.

(Response) We agree that there may be situations that could call for a rapid turnaround in responding to a request for an exception or alternative. The intent of this rule is to ensure the rapid availability of medical countermeasures in the event of a public health emergency, and FDA will respond to all requests regarding the SNS as rapidly as possible. However, we do not believe that requiring FDA to respond within a set timeframe without accounting for the variability and complexity of each request would necessarily serve the public health.

(Comment 5) One comment asked what documentation would be provided to the Department of Homeland Security's Customs and Border Protection Agency (CBP) to allow importation of medical products that are the subject of grants of exceptions or alternatives to labeling requirements.

(Response) This rule has no effect on the information that must be submitted to CBP for imported medical products. That documentation remains unchanged. FDA and CBP will be able to make appropriate determinations regarding products for which exceptions or alternatives have been granted without additional information at the time of entry.

(Comment 6) A comment stated that while the rule appears to permit only minor and technical labeling changes, it appears to be intended to permit FDA to make additional labeling changes based on information that becomes available to FDA after the initial label approval. The comment argued that a change to previously approved labels based on information not previously available alters the conditions under which a product may be sold and may affect the product's value without appropriate compensation to the manufacturer. Furthermore, the comment expressed a general concern that such actions by the government may violate the Constitution's Due Process and Takings provisions. The comment further argued that even if such actions did not rise to the level of Constitutional violations, they would be disincentives to industry developing products with uses covered by the SNS. Finally, the commenter was concerned that FDA may require a manufacturer of investigational products to add language to the outer package labeling of its product in the SNS after the product is licensed, approved, or cleared.

(Response) The concerns expressed in the comment are unfounded. We do not agree that FDA's grant of an exception or alternative to certain FDA labeling requirements under the rule would adversely affect a product's value. This rule applies to medical products that are or will be held in the SNS only. The purpose of the rule is to provide for exceptions or alternatives to certain regulatory requirements if compliance with the requirements could adversely affect the safety, effectiveness, or availability of these products. Therefore, we would anticipate that this rule could encourage, as opposed to discourage, the procurement of medical products by the SNS.

We reiterate that this rule is narrowly drafted to create necessary exceptions or alternatives to specified labeling requirements to ensure that medical products stored in the SNS are available for public use in the event of an emergency. To date, we have received six requests for exceptions or alternatives to labeling requirements, all of which have been initiated by BLA holders or applicants or sponsors of IND applications, with the concurrence of SNS officials. Our experience to date is that this rule does not create disincentives to participation in the SNS, and we note that the comment did not contain any data or information to substantiate this concern. Furthermore, to the extent that the comment is arguing that this rule violates the Due Process and Takings clauses of the Constitution by affecting a product's value without appropriate compensation to the manufacturer, as discussed previously, we disagree. As we have explained, this rule will not adversely affect the value of a product. We do not believe that this rule in any way violates the Constitution.

(Comment 7) One comment expressed concern that relabeling a product suggests product manipulation. The comment stated that over labeling or relabeling creates the possibility for error, damage to the product and potential confusion by the SNS and, ultimately, for the user for whom the product is intended. Further, any of these possibilities may increase product liability exposure for the manufacturer.

(Response) The concerns expressed in the comment are unfounded. As stated in the preamble to the interim final rule, we recognize that relabeling is a potentially time-consuming, costly, and labor-intensive process that could possibly cause product mishandling, sabotage or diversion, or could cause products to be unavailable for dispensing in the event of an emergency. Accordingly, this rule is specifically designed to allow FDA Center Directors to grant exceptions or alternatives to certain labeling requirements for medical products in the SNS to mitigate the need for relabeling. We also note that since the development of the SNS, manufacturers, in conjunction with FDA, the Centers for Disease Control and Prevention/SNS officials and the Department of Health and Human Services/Biomedical Advanced Research and Development Authority, have developed innovative labeling mechanisms for certain products through which relabeling an investigative product requires minimal manipulation post-licensure ( e.g., “zipper” labels or “tear-off” labels on the actual product container).

Regarding the product liability concern, this rule does not authorize the use of unapproved products, or of approved products for unapproved uses in an emergency. This rule instead permits a Center Director to authorize an exception or alternative from certain labeling requirements. Notably, with regard to other product liability concerns the commenter may have, the Public Readiness and Emergency Preparedness (PREP) Act is intended to address tort liability for manufacturers in such circumstances (42 U.S.C. 247d-6(d)).

(Comment 8) A comment stated that the rule would appear to place burdens on a manufacturer. For example, the comment states that the rule does not exempt a sponsor from the requirement that it include in the company's annual report to FDA changes in labeling even when the government initiated the change without input from the manufacturer. The comment suggests that therefore, the company will need to track the activities of the SNS after the product has been distributed.

(Response) FDA clarifies that under 21 CFR 201.26(e), a sponsor or applicant would only have to report a grant of a request for an exception or alternative of labeling requirements if the sponsor or applicant requested the change. We also note that we expect that in the majority of cases, this exception or alternative would be granted during the product approval process. Accordingly, FDA does not expect this rule to impose burdensome reporting requirements on manufacturers.

In this final rule, FDA is amending regulations pertaining to the content and format of medical product labeling. The provisions of this rule allow FDA to grant exceptions or alternatives to certain of those labeling requirements. The labeling regulations to which exceptions or alternatives are permitted under this rule were issued by FDA under authority of the FD&C Act and the PHS Act to mandate particular ways that firms must satisfy the broad requirements and prohibitions in those statutes, such as the prohibition on false and misleading drug and device labeling. As described in section II of this document, and in the interim final rule, FDA has determined that circumstances may arise in which compliance with those regulatory mandates could adversely affect the safety, effectiveness, or availability of certain medical products that are or will be included in the SNS. Moreover, due to the unique nature of the SNS, those products could deviate from particular mandates of existing labeling regulations without violating the broad statutory requirements and prohibitions in the FD&C Act and the PHS Act. For those reasons, FDA is exercising its authority to regulate labeling by modifying the existing regulations in a way that allows exceptions or alternatives for medical products that are or will be included in the SNS.

As explained in the interim final rule, FDA has various sources of authority to issue labeling regulations, including, for example, sections 201(n), 502(a), and 701(a) of the FD&C Act (21 U.S.C. 321(n), 352(a), and 371(a)) for drugs (including biological products) and devices, and sections 351(a)(1)(A) and 351(a)(2)(A) of the PHS Act (42 U.S.C. 262(a)(1)(A) and (a)(2)(A)) for biological products. In addition, as more fully discussed in the interim final rule, FDA has concluded that exceptions or alternatives granted under this rule will not render products misbranded due to the additional safeguards and conditions that may be required when an exception or alternative is granted, as well as the unique storage, deployment and distribution considerations essential to the SNS.

FDA has examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The analysis of costs and benefits of available regulatory alternatives contained in the interim final rule (72 FR 73589 at 73596) is adopted without change in this final rule. By now reaffirming that interim final rule, FDA has not imposed any new requirements. Therefore, there are no additional costs and benefits associated with this final rule.

The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this final rule does not make any changes to the interim final rule or our analysis included therein, the Agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that Agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $136 million, using the most current (2010) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount.

Sections 201.26(b), 610.68(b), 801.128(b), and 809.11(b) of this final rule contain information collection requirements that were submitted for review and approval to the Director of the Office of Management and Budget (OMB), as required by section 3507(d) of the Paperwork Reduction Act of 1995. The information collection requirements were approved and assigned OMB control number 0910-0614 (expires August 31, 2014).

The Agency has determined under 21 CFR 25.30(k) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

In the Federal Register of October 5, 2011 (76 FR 61565), FDA published a notification of preemption review, which was conducted in response to a memorandum from the President that directed Federal Agencies to review recently issued regulations to ensure that any statements concerning preemption can be justified under legal principles governing preemption, including those outlined in Executive Order 13132. In this notification, FDA announced its determination that the preamble to the interim final rule referred to statements concerning preemption that are not justified under legal principles governing preemption. FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132 and has determined that this rule is consistent with the Executive Order. Section 4(a) of this Executive Order requires agencies to “construe * * * a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.” In this rule, FDA is adopting as a final rule regulations permitting FDA Center Directors to grant exceptions or alternatives to certain regulatory labeling requirements applicable to medical products that are or will be included in the SNS. Certain State requirements regarding the format and content of nonprescription drug labeling and/or labeling of approved medical devices may be subject to the express preemption provisions in section 751 of the FD&C Act (21 U.S.C. 379r) (nonprescription drugs) and section 521 of the FD&C Act (21 U.S.C. 360k) (approved medical devices). We also note that even where an express preemption provision is not applicable, implied preemption may arise.

Accordingly, the interim final rule amending 21 CFR parts 201, 312, 314, 601, 610, 801, 807, 809, 812, and 814 which was published at 72 FR 73589 on December 28, 2007, is adopted as a final rule without change.

Teva Animal Health, Inc., 3915 South 48th Street Ter., St. Joseph, MO 64503, has informed FDA that it has transferred ownership of, and all rights and interest in, ANADA 200-236 for Chlortetracycline HCL Soluble Powder to Quo Vademus, LLC, 277 Faison McGowan Rd., Kenansville, NC 28349. Accordingly, the Agency is amending the regulations in 21 CFR 520.441 to reflect the transfer of ownership.

Quo Vademus, LLC, is not currently listed in the animal drug regulations as a sponsor of an approved application. Accordingly, 21 CFR 510.600 is being amended to add entries for this sponsor.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 510 and 520 are amended as follows:

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.

EPA has recently undertaken a series of actions pertaining to the regulation of GHGs that, although for the most part distinct from one another, establish the overall framework for today's final action on the New Hampshire SIP. Four of these actions include, as they are commonly called, the “Endangerment Finding” and “Cause or Contribute Finding,” which EPA issued in a single final action, 1 the “Johnson Memo Reconsideration,”  2 the “Light-Duty Vehicle Rule,”  3 and the “Tailoring Rule.”  4 Taken together and in conjunction with the Clean Air Act (CAA), these actions established regulatory requirements for GHGs emitted from new motor vehicles and new motor vehicle engines; determined that such regulations, when they took effect on January 2, 2011, subjected GHGs emitted from stationary sources to PSD requirements; and limited the applicability of PSD requirements to GHG sources on a phased-in basis.

Recognizing that some states had approved SIP PSD programs that do apply PSD to GHGs, but that do so for sources that emit as little as 100 or 250 tons per year of GHG, and do not limit PSD applicability to GHGs to the higher thresholds in the Tailoring Rule, EPA published a final rule on December 30, 2010, narrowing its previous approval of PSD programs as applicable to GHG-emitting sources in SIPs for 24 states, including New Hampshire (PSD Narrowing Rule). 5 In the PSD Narrowing Rule, EPA withdrew its approval of New Hampshire's SIP, among other SIPs, to the extent that SIP applies PSD permitting requirements to GHG emissions from sources emitting at levels below those set in the Tailoring Rule. Subsequently, New Hampshire's approved SIP provided the state with authority to regulate GHGs, but only at and above the Tailoring Rule thresholds; and Federally required new and modified sources to receive a PSD permit based on GHG emissions only if they emitted at or above the Tailoring Rule thresholds.

On February 7, 2011, in response to the Tailoring Rule and earlier GHG-related EPA rules, NH DES submitted a revision to EPA for approval into the New Hampshire SIP to establish appropriate emission thresholds for determining which new or modified stationary sources become subject to PSD permitting requirements for GHG emissions. Subsequently, on June 14, 2011 (76 FR 34630), EPA published a proposed approval of this SIP submittal. Specifically, New Hampshire's February 7, 2011 SIP revision establishes appropriate emissions thresholds for determining PSD applicability to new and modified GHG-emitting sources in accordance with EPA's Tailoring Rule. Detailed background information and EPA's rationale for the proposed approval are provided in EPA's June 14, 2011, Federal Register action.

EPA also stated in the proposal that if the Agency did approve New Hampshire's changes to its air quality regulations to incorporate the appropriate thresholds for GHG permitting applicability into New Hampshire's SIP, then Section 52.1522(c) of 40 CFR part 52, as included in EPA's SIP Narrowing Rule—which codifies EPA's limiting its approval of New Hampshire's PSD SIP to not cover the applicability of PSD to GHG-emitting sources below the Tailoring Rule thresholds—is no longer necessary. Therefore, EPA is amending section 52.1522 of 40 CFR part 52 by removing the unnecessary regulatory language in subsection (c).

The public comment period on the proposed approval of New Hampshire's SIP revision ended on July 14, 2011. EPA did not receive any comments on the proposed approval of this SIP revision.

Final approval of New Hampshire's February 2, 2011, SIP revision incorporates changes to the state's rules to establish the GHG emission thresholds for PSD applicability set forth in EPA's Tailoring Rule, confirming that smaller GHG sources emitting less than these thresholds will not be subject to PSD permitting requirements under the approved New Hampshire SIP. EPA has determined the SIP revision approved by today's action is consistent with EPA's regulations, including the Tailoring Rule. Furthermore, EPA has determined this SIP revision is consistent with section 110 of the CAA. Pursuant to section 110 of the CAA, EPA approves this revision into New Hampshire's SIP.

As a result of today's action approving New Hampshire's incorporation of the appropriate GHG permitting thresholds into its SIP, paragraph 40 CFR 52.1522(c), as included in EPA's PSD Narrowing Rule, is no longer necessary. 6 Thus, today's action also amends 40 CFR 52.1522 to remove this unnecessary regulatory language.

Upon promulgation of a new or revised NAAQS, sections 110(a)(1) and (2) of the CAA require states to address basic SIP requirements, including emissions inventories, monitoring, and modeling to assure attainment and maintenance for that new NAAQS. On July 18, 1997, EPA promulgated a new NAAQS for ozone based on 8-hour average concentrations, thus states were required to provide submissions to address sections 110(a)(1) and (2) of the CAA for this new NAAQS. North Carolina provided its infrastructure submission for the 1997 8-hour ozone NAAQS on December 12, 2007, and clarified it in a subsequent submission submitted on June 20, 2008. On March 27, 2008, North Carolina was among other states that received a finding of failure to submit because its infrastructure submission was deemed incomplete for elements 110(a)(2)(C) and (J) for the 1997 8-hour ozone NAAQS by March 1, 2008. See 73 FR 16205. Infrastructure elements 110(a)(2)(C) and (J) relate to a SIP addressing changes to its part C prevention of significant deterioration (PSD) permit program as required by the 1997 8-Hour Ozone NAAQS Implementation Rule New Source Review (NSR) Update—Phase 2 Rule (hereafter referred to as the Ozone Implementation NSR Update) recognizing nitrogen oxides (NO X ) a precursor for ozone in 40 CFR 51.166 and 40 CFR 52.21, among other requirements. See 70 FR 71612, (November 29, 2005). The June 20, 2008, submission corrected the deficiencies for which the finding of failure to submit was received. On August 10, 2011, EPA finalized approval of North Carolina's June 20, 2008, SIP revision. See 76 FR 49313.

EPA has determined that North Carolina's federally-approved SIP includes the provisions necessary from the Ozone Implementation NSR Update, including the addition of NO X as a precursor to ozone in 40 CFR 51.166 and 40 CFR 52.21 for the 1997 8-hour ozone standard, and thus, has determined that North Carolina has satisfied the requirements for 110(a)(2)(C) and (J). On December 15, 2011, EPA proposed to approve North Carolina's December 12, 2007, infrastructure submission and proposed conditional approval of infrastructure sub-element 110(a)(2)(E)(ii) for the 1997 8-hour ozone NAAQS. > See 76 FR 77952. 1 CAA section 110(a)(2)(E)(ii) pertains to section 128 State Board requirements which requires at subsection (a)(1) that each SIP shall contain requirements that any board or body which approves permits or enforcement orders be subject to the described public interest and income restrictions. It further requires at subsection (a)(2) that any board or body, or the head of an executive agency with similar power to approve permits or enforcement orders under the CAA, shall also be subject to conflict of interest disclosure requirements.

On January 11, 2012, North Carolina submitted a letter of commitment to EPA to adopt specific enforceable measures related to both 128(a)(1) and 128(a)(2) to address current deficiencies in the North Carolina SIP as outlined in EPA's December 15, 2011, proposed rulemaking. This letter of commitment meets the requirements of section 110(k)(4) of the CAA, 42 U.S.C. 7410(k)(4). Failure to adopt these provisions into the North Carolina SIP within one year (by February 6, 2013) will result in today's conditional approval becoming a disapproval. North Carolina's January 11, 2012, letter can be accessed at http://www.regulations.gov using Docket ID No. EPA-R04-OAR-2011-0352. A summary of the background for today's final action is provided below. See EPA's December 15, 2011, proposed rulemaking at 76 FR 77952 for more detail.

Section 110(a) of the CAA requires states to submit SIPs to provide for the implementation, maintenance, and enforcement of a new or revised NAAQS within three years following the promulgation of such NAAQS, or within such shorter period as EPA may prescribe. Section 110(a) imposes the obligation upon states to make a SIP submission to EPA for a new or revised NAAQS, but the contents of that submission may vary depending upon the facts and circumstances. In particular, the data and analytical tools available at the time the state develops and submits the SIP for a new or revised NAAQS affects the content of the submission. The contents of such SIP submissions may also vary depending upon what provisions the state's existing SIP already contains. In the case of the 1997 8-hour ozone NAAQS, states typically have met the basic program elements required in section 110(a)(2) through earlier SIP submissions in connection with previous ozone NAAQS.

More specifically, section 110(a)(1) provides the procedural and timing requirements for SIPs. Section 110(a)(2) lists specific elements that states must meet for “infrastructure” SIP requirements related to a newly established or revised NAAQS. As already mentioned, these requirements include SIP infrastructure elements such as modeling, monitoring, and emissions inventories that are designed to assure attainment and maintenance of the NAAQS. The requirements that are the subject of this final rulemaking are listed below  2 and in EPA's October 2, 2007, memorandum entitled “Guidance on SIP Elements Required Under Section 110(a)(1) and (2) for the 1997 8-Hour Ozone and PM 2.5 National Ambient Air Quality Standards.”

• 110(a)(2)(A): Emission limits and other control measures.

• 110(a)(2)(B): Ambient air quality monitoring/data system.

• 110(a)(2)(C): Program for enforcement of control measures. 3

• 110(a)(2)(D): Interstate transport. 4

• 110(a)(2)(E): Adequate resources.

• 110(a)(2)(F): Stationary source monitoring system.

• 110(a)(2)(G): Emergency power.

• 110(a)(2)(H): Future SIP revisions.

• 110(a)(2)(I): Areas designated nonattainment and meet the applicable requirements of part D. 5

• 110(a)(2)(J): Consultation with government officials; public notification; and PSD and visibility protection.

• 110(a)(2)(K): Air quality modeling/data.

• 110(a)(2)(L): Permitting fees.

• 110(a)(2)(M): Consultation/participation by affected local entities.

EPA is taking final action to approve North Carolina's infrastructure submission as demonstrating that the State meets the applicable requirements of sections 110(a)(1) and (2) of the CAA for the 1997 8-hour ozone NAAQS, with the exception of CAA section 110(a)(2)(E)(ii). EPA is taking final action to conditionally approve sub-element 110(a)(2)(E)(ii). Section 110(a) of the CAA requires that each state adopt and submit a SIP for the implementation, maintenance, and enforcement of each NAAQS promulgated by the EPA, which is commonly referred to as an “infrastructure” SIP. North Carolina, through DAQ, certified that the North Carolina SIP contains provisions that ensure the 1997 8-hour ozone NAAQS is implemented, enforced, and maintained in North Carolina. EPA received no adverse comments on its December 15, 2011, proposed approval of North Carolina's December 12, 2007, infrastructure submission and proposed conditional approval of 110(a)(2)(E)(ii).

North Carolina's infrastructure submission, provided to EPA on December 12, 2007, and clarified on June 20, 2008, addressed all the required infrastructure elements for the 1997 8-hour ozone NAAQS, with the exception of CAA section 110(a)(2)(E)(ii). EPA has determined that North Carolina's December 12, 2007 submission, as clarified through the State's June 20, 2008 submission, is consistent with section 110 of the CAA, with the exception of CAA section 110(a)(2)(E)(ii).

On January 11, 2012, North Carolina submitted a letter of commitment to EPA to adopt specific enforceable measures related to both CAA sections 128(a)(1) and 128(a)(2) to address the current deficiencies in the North Carolina SIP related to CAA section 110(a)(2)(E)(ii) as outlined in EPA's December 15, 2011, proposed rulemaking. As a result of North Carolina's January 11, 2012, submission, EPA has determined that conditional approval is appropriate because the State has explicitly committed to address current deficiencies in the North Carolina SIP related to sub-element 110(a)(2)(E)(ii) consistent with the requirements of CAA section 110(k)(4).

EPA is conditionally approving the January 11, 2012, submittal with respect to the CAA requirement of sub-element 110(a)(2)(E)(ii). North Carolina must submit to EPA by February 6, 2013, SIP revisions adopting specific enforceable measures related to both CAA sections 128(a)(1) and 128(a)(2) as described in the State's letter of commitment described above. If the State fails to actually submit these revisions by February 6, 2013, today's conditional approval will automatically become a disapproval on that date and EPA will issue a finding of disapproval. EPA is not required to propose the finding of disapproval. If the conditional approval is converted to a disapproval, the final disapproval triggers the Federal Implementation Plan requirement under section 110(c). However, if the State meets its commitment within the applicable timeframe, the conditionally approved submission will remain a part of the SIP until EPA takes final action approving or disapproving the new submittal. If EPA disapproves the new submittal, today's conditionally approved submittal will also be disapproved at that time. If EPA approves the new submittal, North Carolina's infrastructure SIP will be fully approved in its entirety and replace the conditionally approved element in the SIP.

EPA is taking final action to approve North Carolina's December 12, 2007, submission for the 1997 8-hour ozone NAAQS and conditionally approve North Carolina's January 11, 2012, submission because these submissions are consistent with section 110 of the CAA. NC DENR has addressed the elements of the CAA 110(a)(1) and (2) SIP requirements pursuant to EPA's October 2, 2007, guidance to ensure that the 1997 8-hour ozone NAAQS are implemented, enforced, and maintained in North Carolina.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. );

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. );

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by April 6, 2012. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. ( See section 307(b)(2)).

40 CFR part 52 is amended as follows:

Table of Contents I. Background II. This Action III. Final Action IV. Statutory and Executive Order Reviews I. Background

Upon promulgation of a new or revised NAAQS, sections 110(a)(1) and (2) of the CAA require states to address basic SIP requirements, including emissions inventories, monitoring, and modeling to assure attainment and maintenance for that new NAAQS. On July 18, 1997, EPA promulgated a new NAAQS for ozone based on 8-hour average concentrations, thus states were required to provide submissions to address sections 110(a)(1) and (2) of the CAA for this new NAAQS. Georgia provided its infrastructure submission for the 1997 8-hour ozone NAAQS on December 13, 2007, and clarified it in a subsequent submission submitted on September 9, 2008. On March 27, 2008, Georgia was among other states that received a finding of failure to submit because its infrastructure submission was deemed incomplete for element 110(a)(2)(G) for the 1997 8-hour ozone NAAQS by March 1, 2008. See 73 FR 16205. The September 9, 2008, submission clarified that Georgia has the authority to implement emergency powers for the 8-hour ozone standard and that EPA has approved these provisions in the SIP. EPA has determined that Georgia's federally-approved SIP includes provisions which provide the State with the authority to implement emergency powers for the 8-hour ozone standard and thus determined that Georgia has satisfied the requirements for 110(a)(2)(G). On December 5, 2011, EPA proposed to approve Georgia's December 13, 2007, and September 9, 2008, infrastructure submission and supplement for the 1997 8-hour ozone NAAQS. See 76 FR 75849. A summary of the background for today's final action is provided below. See EPA's December 5, 2011, proposed rulemaking at 76 FR 75849 for more detail.

Section 110(a) of the CAA requires states to submit SIPs to provide for the implementation, maintenance, and enforcement of a new or revised NAAQS within three years following the promulgation of such NAAQS, or within such shorter period as EPA may prescribe. Section 110(a) imposes the obligation upon states to make a SIP submission to EPA for a new or revised NAAQS, but the contents of that submission may vary depending upon the facts and circumstances. In particular, the data and analytical tools available at the time the state develops and submits the SIP for a new or revised NAAQS affects the content of the submission. The contents of such SIP submissions may also vary depending upon what provisions the state's existing SIP already contains. In the case of the 1997 8-hour ozone NAAQS, states typically have met the basic program elements required in section 110(a)(2) through earlier SIP submissions in connection with previous ozone NAAQS.

More specifically, section 110(a)(1) provides the procedural and timing requirements for SIPs. Section 110(a)(2) lists specific elements that states must meet for “infrastructure” SIP requirements related to a newly established or revised NAAQS. As already mentioned, these requirements include SIP infrastructure elements such as modeling, monitoring, and emissions inventories that are designed to assure attainment and maintenance of the NAAQS. The requirements that are the subject of this final rulemaking are listed below  1 and in EPA's October 2, 2007, memorandum entitled “Guidance on SIP Elements Required Under Section 110(a)(1) and (2) for the 1997 8-Hour Ozone and PM 2.5 National Ambient Air Quality Standards.”

• 110(a)(2)(A): Emission limits and other control measures.

• 110(a)(2)(B): Ambient air quality monitoring/data system.

• 110(a)(2)(C): Program for enforcement of control measures. 2

• 110(a)(2)(D): Interstate transport. 3

• 110(a)(2)(E): Adequate resources.

• 110(a)(2)(F): Stationary source monitoring system.

• 110(a)(2)(G): Emergency power.

• 110(a)(2)(H): Future SIP revisions.

• 110(a)(2)(I): Areas designated nonattainment and meet the applicable requirements of part D. 4

• 110(a)(2)(J): Consultation with government officials; public notification; and PSD and visibility protection.

• 110(a)(2)(K): Air quality modeling/data.

• 110(a)(2)(L): Permitting fees.

• 110(a)(2)(M): Consultation/participation by affected local entities.

EPA is taking final action to approve Georgia's infrastructure submission as demonstrating that the State meets the applicable requirements of sections 110(a)(1) and (2) of the CAA for the 1997 8-hour ozone NAAQS. Section 110(a) of the CAA requires that each state adopt and submit a SIP for the implementation, maintenance, and enforcement of each NAAQS promulgated by the EPA, which is commonly referred to as an “infrastructure” SIP. Georgia, through EPD, certified that the Georgia SIP contains provisions that ensure the 1997 8-hour ozone NAAQS is implemented, enforced, and maintained in Georgia. Additionally, EPA received no adverse comments on its December 5, 2011, proposed approval of Georgia's December 13, 2007, infrastructure submission.

Georgia's infrastructure submission, provided to EPA on December 13, 2007, and clarified in a subsequent submission submitted on September 9, 2008, addressed all the required infrastructure elements for the 1997 8-hour ozone NAAQS. EPA has determined that Georgia's December 13, 2007, and September 9, 2008 submissions are consistent with section 110 of the CAA.

As already described, EPD has addressed the elements of the CAA 110(a)(1) and (2) SIP requirements pursuant to EPA's October 2, 2007, guidance to ensure that the 1997 8-hour ozone NAAQS are implemented, enforced, and maintained in Georgia. EPA is taking final action to approve Georgia's December 13, 2007, and September 9, 2008, submissions for the 1997 8-hour ozone NAAQS because these submissions are consistent with section 110 of the CAA.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by State law. For that reason, this action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. );

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. );

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by April 6, 2012 Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. ( See section 307(b)(2)).

40 CFR part 52 is amended as follows:

Throughout this document, “we,” “us” and “our” refer to EPA.

On September 12, 2011 (76 FR 56132), EPA proposed to approve the following rule into the California SIP.

We proposed to approve this rule because we determined that it complied with the relevant CAA requirements. Our proposed action contains more information on the rule and our evaluation.

Our proposed approval of Rule 4684 responded to a July 22, 2011 request from the State to parallel process a version of the Rule proposed for local adoption on August 18, 2011. On August 26, 2011, CARB submitted to EPA the version of Rule 4684 that was adopted locally on August 18, 2011. We have reviewed this version, and it is unchanged from the version we proposed for approval on September 12, 2011.

EPA's proposed action provided a 30-day public comment period. During this period, we received no comments.

No comments were submitted that change our assessment that the submitted rule complies with the relevant CAA requirements. Therefore, as authorized in section 110(k)(3) of the Act, EPA is fully approving this rule into the California SIP.

Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve State choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves State law as meeting Federal requirements and does not impose additional requirements beyond those imposed by State law. For that reason, this action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. );

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. );

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and

• Does not provide EPA with the discretionary authority to address disproportionate human health or environmental effects with practical, appropriate, and legally permissible methods under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the State, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by April 6, 2012. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements (see section 307(b)(2)).

Part 52, Chapter I, Title 40 of the Code of Federal Regulations is amended as follows:

On July 6, 2011, the EPA issued a final rule promulgating the Transport Rule (76 FR 48208, August 8, 2011). The Transport Rule limits the interstate transport of emissions of nitrogen oxides (NO X ) and sulfur dioxide (SO 2 ) that contribute to harmful levels of fine particulate matter (PM 2.5 ) and ozone in downwind states. The rule identified emissions within 27 states in the eastern United States that significantly affect the ability of downwind states to attain and maintain compliance with the 1997 and 2006 fine particulate matter NAAQS and the 1997 ozone NAAQS. EPA established trading programs to reduce these emissions through Federal Implementation Plans (FIPs) that regulate electric generating units (EGUs) in the 27 states.

As explained in the preambles to the final Transport Rule (76 FR 48208) and the supplemental notice of final rulemaking (SNFR) (76 FR 80761), EPA updated and improved its modeling platforms and inputs in response to public comments received on the proposed Transport Rule and subsequent Notices of Data Availability (NODAs), and performed other updates. Therefore, some of the results of the analysis performed for the final Transport Rule differed from the results of the analysis conducted for the Transport Rule proposal. Under the proposed Transport Rule, EPA's analysis did not identify Wisconsin, Iowa, and Missouri as states that significantly contribute to nonattainment and/or interfere with maintenance of the ozone NAAQS in another state with respect to the 1997 ozone NAAQS. Under the final Transport Rule's analysis, however, the results indicated that emissions from these states do interfere with maintenance of the ozone NAAQS of another state. The results also showed that emissions from Missouri significantly contribute to nonattainment of the ozone NAAQS in another state. The analysis for the final rule also identified two ozone maintenance receptors, located in Allegan County, Michigan and Harford County, Maryland, which were not identified by modeling conducted for the proposed rule. The analysis indicated that five states—Iowa, Kansas, Michigan, Oklahoma, and Wisconsin—interfered with maintenance problems at these receptors. EPA did not include these states in the final Transport Rule with respect to the 1997 ozone season NAAQS or finalize ozone season NO X budgets for these states, but instead published a supplemental notice of proposed rulemaking (SNPR) (76 FR 40662) to provide the public with an opportunity to comment on the conclusion that these states significantly contribute to nonattainment or interfere with maintenance of the 1997 ozone NAAQS in downwind states. EPA finalized the supplemental notice of proposed rulemaking on December 15, 2011, which was published in the Federal Register on December 27, 2011 (SNFR) (76 FR 80761). The SNFR found that emissions of NO X from sources in Iowa, Kansas, Michigan, Missouri, Oklahoma, and Wisconsin either significantly contributed to nonattainment or interfered with maintenance in downwind states. The SNFR also finalized FIPs for Iowa, Michigan, Missouri, Oklahoma, and Wisconsin that required sources within the states to comply with the Transport Rule. 3

After publication of the final Transport Rule, various parties filed petitions for review of EPA's action in the U.S. Court of Appeals for the District of Columbia Circuit ( EME Homer City Generation, L.P. v. EPA, No. 11-1302 and consolidated cases). On December 30, 2011, upon the motions of various petitioners, the Court ordered the Transport Rule stayed pending the completion of its review.

The Court did not explicitly address the effect of its order on the SNFR affecting Iowa, Kansas, Michigan, Missouri, Oklahoma, and Wisconsin. Because the underlying programs of the Transport Rule have been stayed by the Court, there is no practical way for covered sources under the SNFR to comply with those programs. The SNFR employs the same methodology, modeling, and analysis as the final Transport Rule and extends the programs established in the Transport Rule to additional states. The agency will therefore treat the new rule in the same manner as the underlying Transport Rule, which has been stayed. EPA does not expect covered sources under the SNFR to comply with the provisions of that rule for the duration of the Court's stay.

Table of Contents I. Public Participation and Technical Review by the Advisory Board on Radiation and Worker Health II. Background A. Introduction B. NIOSH Reconsideration of CLL C. Purpose of the Rule III. Summary of Final Rule IV. Regulatory Assessment Requirements A. Executive Order 12866 and 13563 B. Regulatory Flexibility Act C. Paperwork Reduction Act D. Small Business Regulatory Enforcement Fairness Act E. Unfunded Mandates Reform Act of 1995 F. Executive Order 12988 (Civil Justice) G. Executive Order 13132 (Federalism) H. Executive Order 13045 (Protection of Children From Environmental, Health Risks and Safety Risks) I. Executive Order 13211 (Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use) J. Plain Writing Act of 2010 I. Public Participation and Technical Review by the Advisory Board on Radiation and Worker Health

On March 21, 2011, HHS published a notice of proposed rulemaking (76 FR 15268), proposing to treat CLL as a radiogenic cancer. HHS initially solicited public comments from March 21, 2011, to June 20, 2011. Upon request, HHS extended the comment period to July 20, 2011 (76 FR 36891, June 23, 2011).

HHS received comments from seven stakeholders, including the Advisory Board on Radiation and Worker Health, which was required by EEOICPA to provide a technical review of a proposed amendment to the probability of causation guidelines. 2 All of the comments offered support for the inclusion of CLL under the coverage provided by EEOICPA. Specifically, the Advisory Board concurred with the NIOSH position that “given that the law requires the use of the upper 99 percent credibility level in making compensation decisions, the inclusion of CLL despite the limited evidence of radiogenicity, is considered appropriate by NIOSH.” Furthermore, the Advisory Board agreed that the risk model proposed by NIOSH is based on the best available science and methodological approaches to express the dose-response relationship between radiation exposure and CLL. In addition to the technical review submitted by the Advisory Board, three of the seven comments were personal stories submitted by family members of deceased energy employees who developed CLL, and the remaining three comments argued that to be fair to claimants, CLL should be included as a radiogenic cancer under Part B of EEOIPCA. There were no comments opposing this change.

The Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. 7384-7385, established a compensation program to provide a lump-sum payment of $150,000 and prospective medical benefits as compensation to covered employees suffering from designated illnesses incurred as a result of their exposure to radiation, beryllium, or silica while in the performance of duty for the Department of Energy (DOE) and certain of its vendors, contractors, and subcontractors. This legislation also provided for lump-sum payments for certain survivors of these covered employees.

The Department of Labor (DOL) has primary responsibility for administering the compensation program; HHS performs several technical and policymaking roles in support of the DOL program. One of these is to develop guidelines, by regulation, to be used by DOL to assess the likelihood that an employee with cancer developed that cancer as a result of exposure to radiation in performing his or her duty at a DOE facility or an atomic weapons employer facility. The guidelines are published in 42 CFR part 81, and comprise a set of policies and procedures by which DOL determines whether it is “at least as likely as not” that the cancer of a nuclear weapons employee was caused by radiation doses the employee incurred while employed at a facility both involved in the production of nuclear weapons and covered under EEOICPA. The guidelines being amended by this final rule designate CLL as non-radiogenic, and hence had required DOL to assign a probability of causation value of “zero.”

There were two related scientific reasons for designating CLL as non-radiogenic at the time the HHS guidelines were promulgated in 2002. The first was that the epidemiological studies did not demonstrate radiation as the cause of CLL, a conclusion reached by a number of expert scientific committees, as well as by NIOSH.

The second reason was that, even if NIOSH had determined that CLL should be treated as radiogenic, NIOSH scientists judged it would not have been feasible to develop a quantitative risk model, specifying a dose-response relationship between radiation and CLL, given the existing scientific evidence at that time. Hence, it was not feasible to include CLL as a radiogenic cancer under the guidelines.

In the March 21, 2011, notice of proposed rulemaking, NIOSH discussed the results of a panel convened in 2005 to provide judgment on evidence of an association between exposure to ionizing radiation and the risk of developing CLL, and whether CLL should continue to be excluded from eligibility for compensation under EEOICPA (76 FR 15268, 15269-70). NIOSH also discussed four subject matter expert reviews, conducted in 2009, of a draft report of the CLL risk model (76 FR 15268, 15270-71).

NIOSH's recent review found the evidence of radiogenicity offered by epidemiology studies to be non-determinative. NIOSH weighed the non-determinative epidemiologic evidence, along with other factors that included: (1) The mechanistic argument for CLL causation; (2) the similarities between CLL and other compensated cancers; (3) the classification of CLL by the World Health Organization and the National Cancer Institute as a form of non-Hodgkin's lymphoma; and (4) the treatment of CLL as a potentially-compensable radiogenic cancer by the U.S. Department of Veterans Affairs. Upon review of these facts, the Agency no longer believes that it is possible to state that the probability of causation for CLL equals zero. Because NIOSH finds sufficient evidence to include CLL as a compensable cancer under EEOICPA, claimants with CLL will be eligible for dose reconstruction under EEOICPA.

The notice of proposed rulemaking also discussed NIOSH's efforts to develop a quantitative radiation risk model for CLL.

The purpose of this rule is to provide for coverage of CLL under part B of EEOICPA. This revision removes sec. 81.30 from the probability of causation guidelines. CLL is considered radiogenic for the purposes of this compensation program; DOL will no longer be required to assign a probability of causation for CLL of zero, when presented with a claim for dose reconstruction under part B of EEOICPA. In concert with this change, NIOSH adds a CLL risk model to NIOSH-IREP and DOL will refer CLL claims under part B of EEOICPA to NIOSH for dose reconstructions, to be followed by determinations of probability of causation by DOL under these revised guidelines.

This final rule removes 42 CFR 81.30 from part 81, thus rescinding the designation of CLL as a non-radiogenic cancer under this part. The effect of this rescission will be that a qualified claim for CLL under part B of EEOICPA will be referred by DOL to NIOSH for radiation dose reconstruction and, upon completion of the dose reconstruction, DOL will determine the probability of causation and complete the adjudication of the claim on that basis. Presently, such claims are not referred to NIOSH for dose reconstruction, since under the language of sec. 81.30, DOL was required to assign a probability of zero to CLL.

Upon promulgation of this final regulation, DOL will identify open and closed cases (NIOSH estimates the number of closed cases to be about 363) under part B of EEOICPA involving CLL claims and attempt to notify the claimants of the new provision. In addition, NIOSH will assist DOL in identifying active and closed cases involving multiple primary cancers including CLL, to identify those whose outcome might be affected by the new provision. For all cases involving CLL, NIOSH will revise the dose reconstruction to take into account radiation doses relevant to CLL, and DOL will recalculate the probability of causation accordingly.

Executive Orders 13563 and 12866 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 rule has been designated a “significant regulatory action” although not economically significant, under sec. 3(f) of Executive Order 12866. Accordingly, the rule has been reviewed by the Office of Management and Budget.

The rule is consistent with the requirements of 42 U.S.C. 7384n(c). The rule does not interfere with State, local, or Tribal governments in the exercise of their governmental functions.

The rule is not considered economically significant, as defined in sec. 3(f)(1) of E.O. 12866. CLL is a rare cancer, with a lifetime risk of 0.48 percent; according to data provided by NCI, an estimated 1.1 percent of all cancers will be CLL. 3 This low risk among the U.S. population, coupled with the weak evidence for CLL's radiogenicity, indicates DOL is unlikely to receive a substantial volume of claims for CLL, thus limiting the administrative expenses associated with such claims and the potential compensation costs. Since 2001, NIOSH has received approximately 33,000 cases  4 that included all cancers currently covered under EEOICPA; given that an estimated 1.1 percent of all cancers occurring among adults are CLL, NIOSH estimates that approximately 363 of those cases would have sought compensation for CLL. NIOSH also receives an average of 200 new cases per month from DOL, and therefore estimates an expected total of 12,000 cases over the next 5 years; based on the 1.1 percent incidence rate, NIOSH estimates that approximately 132 of those cases will seek compensation for CLL. The Agency expects to review the 363 reopened cases plus 132 new CLL cases in the first 5 years after promulgation of this rule—a total of approximately 99 CLL cases per year for the first 5 years. The estimated cost to NIOSH of conducting dose reconstructions is $12,000 per reconstructed case ($1,188,000 per year); DOL estimates its direct cost per adjudicated case to be about $8,000 ($792,000 per year); and DOE estimates its cost per case to be $198 per each DOL request for employment verification, and $372 for responding to each NIOSH request for exposure data ($56,430 per year). In sum, NIOSH estimates the administrative costs to the three Federal agencies associated with CLL cases to be $2,036,430 per year.

Based on our knowledge of the exposure potential for the claimant population and the probability of causation guidelines discussed above, NIOSH expects that approximately 30 percent of CLL cases—30 cases per year—will result in compensation. Compensated claimants receive $150,000 plus medical expenses, which are estimated to cost about $20,000 per year (costs tend to be higher in the first year of treatment, but benefits are payable only from the date of filing a claim, and most claimants have already begun treatment by that time). The financial award granted to successful claimants comes directly from the U.S. Treasury's Energy Employees Occupational Illness Compensation Fund (42 U.S.C. 7384f); NIOSH estimates that annual compensation will amount to $5,100,000. In total, this rule is estimated to cost the Federal government (the three Federal agencies plus the U.S. Treasury) $7,136,430 per year, or just over 7 percent of the established $100 million annual threshold for economic significance. 5

There are no feasible alternatives to this regulatory action. OMB has reviewed this probability of causation rule for consistency with the President's priorities and the principles set forth in E.O. 12866 and E.O. 13563.

The Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., requires each agency to consider the potential impact of its regulations on small entities including small businesses, small governmental units, and small not-for-profit organizations. We certify that this rule will not have a significant economic impact on a substantial number of small entities within the meaning of the RFA. The rule affects only DOL, DOE, HHS, and certain individuals covered by EEOICPA. Therefore, a regulatory flexibility analysis as provided for under RFA is not required.

The Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., requires an agency to invite public comment on and to obtain OMB approval of any regulation that requires 10 or more people to report information to the agency or to keep certain records. This rule does not contain any information collection requirements. It provides guidelines only to DOL for adjudicating compensation claims and thus requires no reporting or record keeping. Information required by DOL to apply these guidelines is being provided by HHS and by individual claimants to DOL under DOL regulations at 20 CFR part 30. Thus, HHS has determined that the PRA does not apply to this rule.

As required by Congress under the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq. ), the Department will report the promulgation of this rule to Congress prior to its effective date. The report will state that the Department has concluded that this rule is not a “major rule” because it is not likely to result in an annual effect on the economy of $100 million or more.

Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531 et seq. ) directs agencies to assess the effects of Federal regulatory actions on State, local, and Tribal governments, and the private sector “other than to the extent that such regulations incorporate requirements specifically set forth in law.” For purposes of the Unfunded Mandates Reform Act, this rule does not include any Federal mandate that may result in increased annual expenditures in excess of $100 million by State, local or Tribal governments in the aggregate, or by the private sector, adjusted annually for inflation. For 2010, the inflation adjusted threshold is $135 million.

This rule has been drafted and reviewed in accordance with Executive Order 12988, “Civil Justice Reform,” and will not unduly burden the Federal court system. Probability of causation may be an element in reviews of DOL adverse decisions in the United States District Courts pursuant to the Administrative Procedure Act. However, DOL has attempted to minimize that burden by providing claimants an opportunity to seek administrative review of adverse decisions, including those involving probability of causation. HHS has provided a clear legal standard for DOL to apply regarding probability of causation. This rule has been reviewed carefully to eliminate drafting errors and ambiguities.

The Department has reviewed this rule in accordance with Executive Order 13132 regarding federalism, and has determined that it does not have “federalism implications.” The rule does not “have substantial direct effects 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.”

In accordance with Executive Order 13045, HHS has evaluated the environmental health and safety effects of this rule on children. HHS has determined that the rule would have no effect on children.

In accordance with Executive Order 13211, HHS has evaluated the effects of this rule on energy supply, distribution or use, and has determined that the rule will not have a significant adverse effect.

Under Public Law 111-274 (October 13, 2010), executive Departments and Agencies are required to use plain language in documents that explain to the public how to comply with a requirement the Federal Government administers or enforces. HHS has attempted to use plain language in promulgating the final rule consistent with the Federal Plain Writing Act guidelines.

For the reasons discussed in the preamble, the Department of Health and Human Services amends 42 CFR part 81 as follows:

USDA is withdrawing its direct final rule published on December 1, 2011 (76 FR 74722), entitled “Agriculture Acquisition Regulation, Labor Law Violations,” as USDA received an adverse comment. This document officially withdraws the direct final rule.

We are revising our ROW general regulations at 50 CFR part 29, which prescribe the procedures for filing applications for ROWs over and across Service-administered lands and the terms and conditions under which we grant these ROWs, to update or add addresses of several Service Regional Offices and to correct the names of the House and Senate Committees we must notify upon receipt of an application for a right-of-way for an oil and gas pipeline that is 24 inches or more in diameter and again before granting a right-of-way.

Section 553 of the Administrative Procedure Act, 5 U.S.C. 553(b)(3)(B), provides that, when an agency for good cause finds that notice and public procedure are impracticable, unnecessary, or contrary to the public interest, the agency may issue a rule without providing notice and an opportunity for public comment. We have determined that there is good cause for making this rule final without prior proposal and opportunity for comment because we are merely updating the addresses for four of the Service's Regional Offices, adding an address for one of the Service's Regional Offices, and correcting the names of the House and Senate Committees we must notify upon receipt of an application for a right-of-way for an oil and gas pipeline that is 24 inches or more in diameter and again before granting a right-of-way. Thus, notice and public procedure are unnecessary. We find that this constitutes good cause under 5 U.S.C. 553(b)(3)(B).

In accordance with 5 U.S.C. 553(d), the Service finds there is good cause for this action to become effective immediately upon publication. The immediate effective date for this action is authorized under 5 U.S.C. 553(d)(3), which allows an effective date less than 30 days after publication “as otherwise provided by the agency for good cause found and published with the rule.” The purpose of the 30-day waiting period prescribed in section 553(d) is to give affected parties a reasonable time to adjust their behavior and prepare before the final rule takes effect. This rule, however, does not create any new regulatory requirements such that affected parties would need time to prepare before the rule takes effect. Rather, this rule simply updates, corrects, and adds addresses for the Service's Regional Offices, and corrects the names of the House and Senate Committees we must notify upon receipt of an application for a right-of-way for an oil and gas pipeline that is 24 inches or more in diameter and again before granting a right-of-way. For this reason, the Service finds good cause under 5 U.S.C. 553(d)(3) for this action to become effective on the date of publication of this action.

We have determined that the public notice and comment provisions of the Administrative Procedure Act, 5 U.S.C. 553(b), do not apply to this rulemaking because the changes being made relate solely to matters of agency organization. We have determined that there is good cause for making this rule final without prior proposal and opportunity for comment because we are merely updating the addresses for four of the Service's Regional Offices, adding an address for one of the Service's Regional Offices, and correcting the names of the House and Senate Committees we must notify upon receipt of an application for a right-of-way for an oil and gas pipeline that is 24 inches or more in diameter and again before granting a right-of-way. Thus, notice and public procedure are unnecessary. We find that this constitutes good cause under 5 U.S.C. 553(b)(3)(B).

We have reviewed this rule under the following statutes and executive orders governing rulemaking procedures: the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1501 et seq.; the Regulatory Flexibility Act, 5 U.S.C. 601 et seq.; the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 801 et seq.; the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.; the National Environmental Policy Act of 1969, 42 U.S.C. 4321 et seq.; Executive Order 12630 (Takings); Executive Order 12866 (Regulatory Planning and Review); Executive Order 12988 (Civil Justice Reform); Executive Order 13045 (Economic Significance); Executive Order 13132 (Federalism); Executive Order 13175 (Tribal Consultation); and Executive Order 13211 (Energy Impacts). This rule does not trigger any of the procedural requirements of those statutes and executive orders, since this rule merely updates and adds addresses for Fish and Wildlife Service offices, and corrects the names of the House and Senate Committees we must notify upon receipt of an application for a right-of-way for an oil and gas pipeline that is 24 inches or more in diameter and again before granting a right-of-way.

This rule is not subject to Executive Order 12045 (62 FR 19885, April 23, 1997), because it is not economically significant. This action does not involve technical standards; thus the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 271 et seq. ) do not apply. This rule also does not require special consideration of issues related to environmental justice as required by Executive Order 12898.

The Congressional Review Act (CRA) (5 U.S.C. 801 et seq. ) as added by the Small Business Regulatory Enforcement Fairness Act of 1966, generally provides that, before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. Section 808 allows the issuing agency to make a rule effective sooner than otherwise provided by the CRA if the agency makes a good cause finding that notice and public procedure is impracticable, unnecessary, or contrary to the public interest. This determination must be supported by a brief statement. 5 U.S.C. 808(2). As stated previously, the Service has made such a good cause finding, including the reasons therefore, and established an effective date immediately upon publication in the Federal Register . The Service will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . These updates and the addition to 50 CFR part 29 do not constitute a “major rule” as defined by 5 U.S.C. 804(2).

For the reasons set forth in the preamble, we amend title 50, chapter I, subchapter C of the Code of Federal Regulations as follows: