Regarding the applicability of our analysis to nonutility sectors, we continue to believe that our conclusions are valid for all sectors, and further, that the effects from the electric utility industry dominate those from other sectors. We acknowledge that the results for the SO2 cap for utilities cannot be extended to non utilities that are not similarly capped. However, our model runs for NOx reflected the absence of a cap, and are therefore valid for other uncapped sectors. Thus in the case of industrial boilers, which behave similarly to utilities, we would expect to see similar efficiency improvements and availability improvements occurring in tandem, resulting in either modest increases or decreases. Because the overall emissions from this sector are significantly smaller than for utilities, the modeled effects for utilities are expected to dominate the analysis.

Finally, for other industrial sectors, we do not anticipate that emissions increases will result from equipment replacement activities that qualify as RMRR under today's rule. While some efficiency improvements may result, the overall effect of these improvements will not be to induce greater demand and greater emissions, as was shown by the modeling for utilities ( i. e., demand depends on Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 19, 2003 87 independent factors). Indeed, without increased demand,

efficiency improvements that lower emissions per unit of output would result in a decrease in emissions.

Therefore, we affirm the overall conclusion of our analysis   that today's rule has no practical effect on the environmental benefits of major NSR in the future. We have presented additional, more detailed supporting information in our final RIA and our response to comments document, both of which can be found in the docket for today's action.

K. Consideration of Other Options In addition to the cost based approaches that we proposed, we also asked for comment on age based and capacity based approaches, and any other viable option for addressing RMRR.

1. Annual Maintenance, Repair and Replacement Allowance We are not taking action on the proposed Annual Maintenance, Repair and Replacement Allowance option for the RMRR exclusion, and therefore public comments on this option are not addressed at this time. We will address comments on our proposed Annual Maintenance, Repair and Replacement Allowance if and when we take final action on that proposal.

2. Capacity Based Option As mentioned above, we considered the alternative option of developing an RMRR provision based on the capacity of a process unit. Under such an approach, an owner or Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 19, 2003 88 operator could undertake any activity that does not increase the capacity of the process unit. Basing RMRR on capacity has appeal for several reasons. The primary objective of RMRR is to keep a unit operating at capacity and/ or availability. In addition, the linkage between capacity and environmental impact is more apparent than that between cost and environmental impact. Finally, this type of approach might, in principle, be easier to use before beginning actual construction than some of the cost based approaches.

Several commenters were concerned with defining the capacity of a process unit. Capacity may be defined based on input or output. Nameplate capacity of a process unit may vary greatly from the capacity at which the process unit may be able to operate. It may be more appropriate in some industries to measure capacity based on input while in others on output. Commenters felt that a capacity based approach would not be workable at complex manufacturing sources, because " capacity" as a useful shorthand term for the processing capability correlates exactly only with a historical feed or product slate no longer available or made. A number of commenters supported a capacity based option, generally indicating that a capacity based option would be simpler and less burdensome to use than the other proposed approaches. Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 19, 2003 89 Another large concern of commenters was that a capacity based approach could prevent facilities from performing activities that make the facilities more efficient. RMRR provisions need to include some form of the other approaches to account for energy efficiency projects at utilities, which could increase output capacity ( i. e.,

production) without necessarily increasing heat input or fuel consumption. Some commenters noted that maximum hourly emissions is a more appropriate surrogate for a change in capacity, because it is consistent with existing NSPS procedures and with averaging periods for ambient air quality monitoring and standards.

We agree that an appropriate capacity based approach would have to be tailored to various types of sources, with capacity based on input for some and on output for others.

As an example, in a review of promulgated and proposed Maximum Achievable Control Technology standards, six of eleven standards measured capacity based on process unit output while five standards based capacity on input. In fact, the NSPS exclusion for increases in production rate at 40 CFR 60.14( e) originally was dependent upon the " operating design capacity" of an affected facility. In proposed revisions to the NSPS program published on October 15, 1974,

we state ( 39 FR 36948):

" The exemption of increases in production rate is Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 19, 2003 90 no longer dependent upon the " operating design capacity." This term is not easily defined, and for certain industries the " design capacity" bears little relationship to the actual operating capacity of the facility."

We also agree that a capacity based approach has its limitations, as described by the commenters. We have concluded that the ERP eliminates the need to implement the capacity based approach. We have decided not to finalize a capacity based approach.

3. Age Based Option Under our proposed age based approach, any process unit under a specified age could undergo any activity that does not increase the capacity of a process unit on a maximum hourly basis without triggering the requirements of the major NSR program. However, the activities could not constitute reconstruction of the process unit; that is,

their cost could not exceed 50 percent of the cost of a replacement process unit. The age of the process unit would likely be in the range of 25 50 years. We also proposed that the owner or operator would have to become a Clean Unit as defined at 40 CFR 51.165( c)( 3), 51.166( t)( 3), and 52.21( x)( 3), once the age of a process unit exceeds the age threshold. Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 19, 2003 91 Such an approach would provide an owner or operator a clear understanding of RMRR for an extended period of time.

It also may provide the owner or operator greater flexibility than under the current system for a limited period of time. Like the capacity based approach, this approach would, in principle, allow for a fairly simple preconstruction determination of applicability.

Very few commenters expressed any interest in developing this type of approach. Their concerns centered around defining capacity and establishing the age cut off ( because the useful life of equipment is difficult to establish and may vary greatly). Other concerns raised by commenters were that some of the activities that would be allowed at newer sources do not fit within any ordinary meaning of RMRR and some of the activities that would be forbidden at older facilities would come within that meaning, and also that some sources may consciously, and appropriately, engage in aggressive RMRR as a method of maximizing the life span of its process units, and an agebased approach would discriminate against them.

One commenter stated that EPA should establish a normal lifetime, tailored to each industry, beyond which industry would need to install BACT or shut down. This type of approach would obviously require a substantial amount of time and analytical effort. Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 19, 2003 92 The age of a source alone is not a legitimate reason to require the addition of pollution control equipment. Age has no direct bearing on a unit's environmental impact; some facilities maintain equipment better than others. We have decided not to promulgate an age based approach. We have several basic concerns with this approach that we have not been able to reconcile. We also believe that the equipment replacement approach largely addresses the commenters'

concerns regarding the age based approach.

Thus, we have decided not to finalize a rule using this approach.

L. Specific List of Excluded Activities Several commenters supported the development of lists of activities that are considered RMRR; some of these commenters also supported developing lists of activities that do not qualify as RMRR. Commenters suggested various ways in which such lists could fit into the overall RMRR program. We are concerned, however, that such a list would have to be implemented through rulemaking, which would require a considerable amount of time and resources.

A commenter suggested two ways by which we could develop a list of qualifying activities. First, we could review records for ongoing enforcement activity, to identify activities that we have and have not already alleged to be Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 19, 2003 93 RMRR. There is an ample body of knowledge for electric power plants. Second, we could identify where activities would fall with respect to the cost criteria, then adjust the classification of each activity based on the WEPCO criteria to prepare lists of routine and nonroutine activities.

Some commenters felt that industry specific lists of routine and nonroutine activities would provide the best interim clarification to major NSR until legislative reform is in place. Other commenters opposed the development of lists of activities that are considered RMRR, contending that such lists would become quickly outdated.

Some commenters requested that certain activities be specifically classified as RMRR. These activities included the following:

S The common practice of changing out the engine core in a combustion turbine when it is due for overhaul ( to reduce downtime). The removed engine core is overhauled offline, and is then available to be switched in for the next like kind engine core that reaches the point of overhaul. Unless the parts are upgraded, the heat input remains the same and so does the emissions rate.

S Any change that does not increase the achievable hourly emissions ( as determined based on the permit and/ or Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 19, 2003 94 original design parameters) of existing equipment,

processes, and emissions units.

Another commenter suggested the following list:

S Certain activities, for example, boiler tuning and maintenance, repair and replacement of air pollution equipment or CEMS should be categorically exempted as RMRR.

S Any project that is part of a long term service agreement ( primarily gas turbines) should be categorically exempted from major NSR.

S Any project involving steam turbine overhaul work should be categorically exempted from major NSR.

We believe there are simply too many activities in too many industries to effectively improve major NSR implementation through creation of lists. Moreover, lists would be a " snapshot in time" that would need to be reviewed and periodically updated for each industry sector. EPA has consequently decided to not list equipment replacements activities that are categorically excluded as RMRR.

M. Stand alone Exclusion for Energy Efficiency Projects In the proposal, we acknowledged that certain types of projects that improve energy efficiency would not qualify as RMRR. We solicited comment on whether there was the need for a " stand alone" exclusion for activities that promote Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 19, 2003 95 energy efficiency.

Many commenters supported a stand alone exclusion from major NSR for energy efficiency projects. With the following safeguards, they favored specifically excluding from the definition of " major modification"

activities/ projects that promote energy efficiency and/ or resource conservation when: ( 1) The project results in lower emissions per unit of production or lower energy utilization per unit of production; ( 2) the percent decrease in emissions or energy utilization per unit of production is greater than the percent increase in maximum hourly emission rates; ( 3) project costs do not exceed 50 percent of the replacement value of the process unit; and ( 4) the project does not result in an increase in allowable emissions.

Other commenters pointed out that efficiency upgrades will frequently create incentives to further utilize a source and subsequently increase mass emissions. One commenter stated that if activities that result in small efficiency gains can qualify as RMRR, older, dirtier electric generating units will be better able to out compete newer, much cleaner plants ( that have higher costs due to emission controls).

One commenter stated that EPA is incorrect in stating that energy efficiency projects are being discouraged by major NSR, particularly under the new actual to projected Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 19, 2003 96 actual applicability test. This commenter added that the only projects that are discouraged by major NSR are ones that increase emissions. This commenter felt that the December 2002 final major NSR rules provide a broad range of major NSR exemptions ( including revised baseline determinations, Clean Unit designations, pollution control projects, PALS, and combinations of these provisions, as well as an RMRR exemption) under which energy efficiency projects will certainly occur.

We strongly support efforts to improve energy efficiency at existing power plants. These activities reduce the amount of air pollution emitted per unit of electricity generated and also reduce greenhouse gas emissions. We believe that today's ERP supports energy efficiency projects and that the actual to projected actual applicability test contained in the December 2002 NSR final rules also should remove impediments to energy efficiency projects. Together, these rules will obviate the need for a specified RMRR provision for energy efficiency projects.

Thus, at this time we are not finalizing a provision to categorically exclude energy efficiency projects from major NSR.

N. Legal Basis The modification provisions of the NSR program in parts Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 19, 2003 97 C and D of title I of the CAA are based on the definition of modification in section 111( a)( 4) of the CAA. The term " modification" means " any physical change in, or change in the method of operation of, a stationary source which increases the amount of any air pollutant emitted by such source of which results in the emission of any air pollutant not previously emitted." As we observed in the notice of proposed rulemaking for this rule, that definition contemplates that you will first determine whether a physical or operational change will occur. If so, then you proceed to determine whether the physical or operational change will result in an emissions increase over baseline levels.

Real world, common sense usage of the word " change" in " physical change" and " change in the method of operation"

shows that " change" is susceptible to multiple meanings.

As we have noted previously, " EPA has always recognized that Congress did not intend that every activity at an existing facility be considered a physical or operational change for purposes of NSR." 57 FR 32,314, 32,319 ( July 21, 1992).

Conceivably, " change" could encompass a range of activities from periodically replacing filters in production machinery,

to once in a lifetime anticipated replacement of a component, to complete replacement of a production unit.

For example, all cars must periodically have their oil Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 19, 2003 98 " changed." When considered from one perspective, this activity does represent a " change" because old oil is removed and new oil is added. From another perspective,

however, this activity would not be considered a change because it does not alter any significant characteristic of the car.

More to the point, chemical and pharmaceutical manufacturing operations often are designed, operated, and permitted as " multi function" facilities. These facilities have numerous pieces of equipment ( such as storage tanks,

reactors, distillation columns, centrifuges, filter dryers,

etc.) that can be reconfigured to accommodate a wide variety of products and operating conditions. When switching from product X to product Y, a plant can make substantial " changes" in the types of equipment used, the processing conditions, and the raw materials, reagents, solvents, and other processing materials. In this case, the same basic equipment is used to make a wide variety of end products.

But, as long as the facility is operated as designed and permitted, we would not consider ( and have not considered over the 20+ year life of the NSR program) such changes to be physical or operational " changes" for purposes of administering the NSR program.

Similarly, manufacturing equipment often is built with Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 19, 2003 99 expendable parts. For example, industrial gas turbines,

such as those used to drive compressors on natural gas pipelines, regularly need to have parts replaced as they wear out due to the high temperature and pressure conditions inside the turbine. In fact, these gas turbines are built with the knowledge and expectation that such replacements will be needed. In recognition of this fact, under the New Source Performance Standard for gas turbines, 40 C. F. R. Part 60 Subpart GG, we have concluded that " replacement of stator blades, turbine nozzles, turbine buckets, fuel nozzles,

combustion chambers, seals, and shaft packings" are not " changes" for regulatory purposes. Cite to EPA 450/ 2 77

017a, background support document for GG. Such replacements are akin to getting a new set of brakes on a car   not something that happens often, not an activity that is necessarily inexpensive, but plainly an activity that is an expected part of maintaining and operating the facility and one that does not represent an alteration of the affected process unit.

As the preceding examples suggest, identifying activities that are " changes" for NSR purposes   and thus potentially trigger the need for an NSR permit   requires the exercise of Agency expertise. The application of agency expertise to the interpretation of this statutory term is the classic situation in which an agency has been accorded Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 19, 2003 100 deference under Chevron, U. S. A., Inc. v. NRDC, 467 U. S. 837 ( 1984).

Historically, we have asserted the power to interpret the relevant statutory terms. For example, even though both the NSPS and NSR programs incorporate the definition of " modification" from section 111, from the outset EPA has adopted quite disparate readings of the term in our rules.

See 57 Fed. Reg. 32314, 32316 ( July 21, 1992) ( WEPCO rule discussion of how emission increases are calculated differently for the NSPS and NSR programs). The NSPS program requires a change to result in an increase in the hourly potential to emit of the facility. 40 C. F. R. 60.14( a)

( b). In contrast, under NSR, we require an increase in annual emissions. E. g., 40 C. F. R. 51.165( a)( 1)( x). These disparate tests reflect the Agency's view that the statutory term " modification" must be construed with a view to what makes sense in particular statutory context, and are not obvious on their face.

The exclusions from NSR we adopted in 1980 also reflect the exercise of the Chevron discretion. Not only did we adopt the RMRR exclusion at that time, but we also adopted exclusions for increases in the hours of operation, fuel changes, and raw material changes. Only the RMRR exclusion arguably could be justified as de minimis. For example, by Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 19, 2003 11 As discussed below, our regulations provided a comparable exclusion from NSPS at the time of the 1977 Amendments that established the NSR program.

101 doubling hours of operation, a 500 ton per year emitting plant could conceivably double its emissions. 11 The extra 500 tpy is far above any level EPA has ever thought justifiable as de minimis. E. g., 40 C. F. R. 51.166( b)( 23)( i)

( definition of " significant"). Nor is it likely that these other exclusions could be based on some inherent power to adopt categorical exemptions from the Act's commands. See Alabama Power Company v. Costle, 636 F. 2d 323, 359 ( D. C.

Cir. 1980) (" categorical exemptions . . . are not favored").

Accordingly, these other exclusions must be justified as an exercise of Chevron discretion.

It is important to note that, in 1977 when Congress incorporated by reference into the NSR program the preexisting NSPS statutory definition of modification, EPA had already adopted and had been administering regulations and policy under the NSPS program related to the meaning of the term " modification." Our rules and policy provided that certain significant activities did not constitute physical or operational changes under the NSPS program prior to 1977 ( or, for that matter, under the NSPS program as administered today). In addition to the gas turbine example provided above, perhaps the best indication that EPA did not consider the terms " modification" or " change" to cover everything Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 19, 2003 102 other than de minimis activities is the exclusion for production rate increases under the NSPS program. 40 C. F. R.

Section 60.14( e)( 2).

Under this provision, projects valued at millions of dollars can be implemented   with no limitations on the nature of the project   without triggering applicable NSPSs.

For example, up to 10 percent of the asset value of affected operations at a kraft pulp mill can be invested in a project without triggering the applicable NSPS, 40 C. F. R. Part 60 Subpart BB. The affected facilities at a kraft pulp mill typically are valued in excess of $ 100 million. Cite.

Therefore, an owner or operator can implement projects costing millions of dollars without triggering the applicable NSPS. This holds true regardless of the nature of the project   it can be a " like kind" replacement of the kind addressed by today's rule or it can result in a substantial change in the nature of the operation. Thus,

under the NSPS program that existed when Congress enacted NSR and incorporated into NSR the applicable NSPS definitions, projects of substantial cost that result in substantial change in affected facilities were not considered " changes." The same is true under the NSPS program as it stands today.

We recognize that the Agency previously has not Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 19, 2003 12 We have taken positions in numerous court filings concerning the proper interpretation and usage of key statutory terms, such as " physical change" and " any physical change." These positions were based on reasonable statutory interpretations of which the regulated community had fair notice, and continue to be the law governing prior activities at covered facilities. We now, however, are using our Chevron authority to define key terms for future activities at covered facilities because the terms have multiple meanings and we now believe the new definitions are most appropriate for the Clean Air Act regulatory regime going forward.

103 specifically asserted that our interpretation of " change"

and the exclusions from NSR are based on an exercise of Chevron discretion. In some instances, such as in a decision of the EAB, In re: Tennessee Valley Authority, 9 E. A. D. 357 ( EAB 2000), and in briefs in various enforcementrelated cases, we have previously interpreted " change" such that all changes, even trivial ones, are encompassed by the Act, and thus we generally interpreted the exclusion as being limited to de minimis circumstances. However, EPA does have the authority to interpret these key terms through rulemaking. Upon further consideration of the history of our actions, the statute, and its legislative history, EPA believes that a different view is permissible, and, for policy reasons discussed above, more appropriate.

Therefore, we adopt this view prospectively in today's action. 12 The argument that our authority to exclude certain activities from being modifications under new source review can only be based on a de minimis rationale sometimes relies on the word " any" used to modify " physical change" and Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 19, 2003 13 We note that the word " any" is simply a modifier that does not change the meaning of the word it modifies. For example, using the term " any" to modify the word " car" does not somehow change or expand the meaning of the word " car." " Any" simply means that, once you have decided what a car is, then all objects meeting the definition are encompassed.

104 " change in the method of operation," pointing to the word " any" in the definition of " modification" as a signal from Congress that the term " change" must be interpreted as encompassing the broadest possible sense of the term. Such an interpretation is not compelled by the language and legislative history of the statute, as demonstrated by the manner in which we have interpreted the word " change" under both the NSPS and the NSR programs. 13 Nothing in the appellate caselaw directly disposes of this issue in a manner that prevents a new interpretation today. Two cases, Alabama Power and Wisconsin Electric Power Co. v. Reilly, 893 F. 2d 901 ( 7th Cir. 1990) (" WEPCO"), are relied on by some commenters to assert that EPA must interpret " modification" and " change" expansively and base all exclusions on a de minimis rationale. However, in Alabama Power, the issue before the court was the emissions increase portion of the definition of " modification." The court would have allowed de minimis increases in emissions to be exempt from requirements applying to " modifications"

under new source review but not emissions increases equal to the thresholds set by statute for new construction. 636 Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 19, 2003 105 F. 2d at 399  400. The court did not have before it the issue of what is a " change" and did not decide this issue.

In WEPCO, both parties advanced the view that the statute was clear on its face. EPA advanced the view that the term " modification" is necessarily broad, and that only de minimis departures are appropriate. WEPCO asserted that the plain meaning of the term " physical change" allowed for the five large scale rehabilitation projects it contemplated at its Port Washington plant. The WEPCO court held that the rehabilitation projects at issue were too large to reasonably conclude that they should not be treated as physical changes. The court's holding that the statute did not require the interpretation advanced by WEPCO does not deny EPA the discretion to decide to adopt a different,

reasonable interpretation of the term " modification."

While the Court in WEPCO decided that the projects in that case were physical changes, the decision in WEPCO does not answer the question of where to draw the line between activities that should and should not be considered " changes." Nevertheless, contrary to the suggestions of several commenters, the projects at issue in WEPCO would have cost more than the 20 percent of replacement cost threshold selected today and, barring other applicable exclusions, would have been subject to case by case review Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 19, 2003 14As pointed out above, we note that the U. S. District Court for the Southern District of Ohio recently issued an opinion in the Agency's NSR enforcement case against Ohio Edison. ( cite) The case included a series of projects with absolute and relative costs well below those at issue in WEPCO. The court determined, again at our urging, that these projects did not qualify for the existing RMRR exclusion. The Agency asserted in that case that the then existing RMRR exclusion should be applied in a narrow fashion such that only de minimis projects should be excluded under that rule. The Agency sought and received from the court broad deference with regard to the Agency's interpretation of the CAA and the relevant EPA rules. EPA today is adopting for future purposes a new interpretation of the CAA and is finalizing a revision to the RMRR regulation. The decision in Ohio Edison does not preclude the interpretation and regulation finalized in today's action.

106 in the PSD program. See section III. D. above. 14 Some commenters argued that, to further the purposes of the statute, any interpretation must result in the eventual elimination of so called " grandfathered" facilities. We recognize the need to reduce emissions from many existing plants   regardless of whether they are " grandfathered"

( because they have never gone through NSR) or whether they have previously gone through NSR but can further reduce their emissions. EPA and States have issued regulations under a variety of statutory provisions to accomplish this goal in the past, and we will continue to do so in the future. We do not believe, however, the modification provisions of the Act should be interpreted to ensure that all major facilities eventually trigger NSR. In fact, such an interpretation cannot be squared with the plain language Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 19, 2003 107 of the Act.

An existing source   whether grandfathered or not   triggers NSR only if it makes a physical or operational change that results in an emissions increase. Thus, a facility can conceivably continue to operate indefinitely without triggering NSR   making as many physical or operational changes as it desires   as long as the changes do not result in emissions increases. This outcome is an unavoidable consequence of the plain statutory language and is at odds with the notion that Congress intended that every major source would eventually trigger NSR. Moreover, there is nothing in the legislative history of the 1977 Amendments, which created the NSR program, to suggest that Congress intended to force all then existing sources to go through NSR. To the extent that some members of Congress expressed that view during the debate over the 1990 amendments, such statements are not probative of what Congress meant in 1977. Central Bank of Denver, N. A. v.

First Interstate Bank of Denver, N. A., 511 U. S. 164, 185

86 ( 1994), and cases cited.

In deciding to incorporate by reference the statutory definition of " modification" in section 111, Congress's intent cannot have been to preclude us from adopting an interpretation of " modification" or " change" that differs from one that sweeps in all activities at a source. Under Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 19, 2003 108 the NSPS program, this interpretation did not apply at the time of the 1977 amendments. When the NSPS definition of " modification" was adopted as part of the NSR program in 1977, the Congressional Record explained that this provision, "[ i] mplements conference agreement to cover " modification" as well as " construction" by defining " construction" in part C to conform to usage in other parts of the Act." 123 Cong. Rec. 36331 ( Nov. 1, 1977)( emphasis added). Although we do not assert that the NSPS interpretation is the only one we could have adopted for NSR purposes ( we followed quite a different interpretation from 1980 2002), at the very least it delineates a zone of discretion within which EPA may operate.

Our interpretation today of physical or operational change in a flexible way furthers the purposes of the statute. Congress made it clear that the CAA in general,

and the NSR program in particular, should be administered in a manner that protects the environment and promotes the productive capacity of the nation. CAA Section 101( b)( 1).

The Chevron Court noted, " Congress sought to accommodate the conflict between the economic interest in permitting capital improvements to continue and the environmental interest in improving air quality" when it established the NSR program.

Chevron, 467 U. S. at 851. Generally, we believe that these Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 19, 2003 109 goals are best accomplished by providing state and local governments with as much flexibility as possible to make decisions as to what emissions reductions are needed in their jurisdictions to attain and maintain good air quality.

See CAA Section 101( a)( 3).

It is now clear that many power plants and industrial facilities must substantially reduce their emissions in order to allow States to meet the stringent federal air quality standards that the Supreme Court upheld in 2002.

Under the Clean Air Act, Congress designed a number of regulatory programs that will collectively achieve the necessary reductions. Although the NSR program will effectively limit emissions from new and modified sources,

it was not designed to achieve emission reductions from every existing source.

IV. Administrative Requirements for This Rule A. Executive Order 12866  Regulatory Planning and Review Under Executive Order 12866 [ 58 Federal Register 51,735 ( October 4, 1993)], we must determine whether the regulatory action is " significant" and therefore subject to review by the Office of Management and Budget ( OMB) and the requirements of the Executive Order. The Executive Order defines " significant regulatory action" as one that is likely to result in a rule that may:

( 1) Have an annual effect on the economy of $ 100 Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 19, 2003 110 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition,

jobs, the environment, public health or safety, or State,

local, or tribal governments or communities;

( 2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;

( 3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients thereof; or ( 4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

Pursuant to the terms of Executive Order 12866, OMB has notified us that it considers this an " economically significant regulatory action" within the meaning of the Executive Order. We have submitted this action to OMB for review. Changes made in response to OMB suggestions or recommendations will be documented in the public record.

All written comments from OMB to EPA and any written EPA response to any of those comments are included in the docket listed at the beginning of this notice under ADDRESSES. In addition, consistent with Executive Order 12866, we consulted extensively with the State, local and tribal agencies that will be affected by this rule. We have also Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 19, 2003 111 sought involvement from industry and public interest groups.

B. Executive Order 13132  Federalism Executive Order 13132, entitled " Federalism" ( 64 FR 43255, August 10, 1999), requires us to develop an accountable process to ensure " meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications."

" Policies that have federalism implications" are defined in the Executive Order to include regulations that 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."

This final rule does not have federalism implications.

Nevertheless, in developing this rule, we consulted with affected parties and interested stakeholders, including State and local authorities, to enable them to provide timely input in the development of this rule. A summary of stakeholder involvement appears above in section II. DC. of this notice. This rule will not have substantial direct effects on the States, on the relationship between the national government and the State and local programs, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. WhileWe expect this rule will result in some Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 19, 2003 112 expenditures by the States, we expect those expenditures to be limited to $ 580,160000 for the estimated 112 affected reviewing authorities. This figure includesestimate reflects the small increase in burden imposed upon reviewing authorities in order for them to revise the State'stheir State Implementation Plans ( SIP). However, this revision provides sources permitted by the States greater certainty in application of the program, which should in turn reduce the overall burden of the program on State and local authorities. Thus, the requirements of Executive Order 13132 do not apply to this rule.

C. Executive Order 13175  Consultation and Coordination with Indian Tribal Governments Executive Order 13175, entitled " Consultation and Coordination with Indian Tribal Governments" ( 65 FR 67249,

November 6, 2000), requires EPA to develop an accountable process to ensure " meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications." We believe that this rule does not have tribal implications as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply.

The purpose of today's final rule is to add greater flexibility to the existing major NSR regulations. These changes will benefit reviewing authorities and the regulated Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 19, 2003 113 community, including any major source owned by a tribal government or located in or near tribal land, by providing increased certainty as to when the requirements of the major NSR program apply. Taken as a whole, today's rule should result in no added burden or compliance costs and should not substantially change the level of environmental performance achieved under the previous rules and guidance.

We anticipate that initially these changes will result in a small increase in the burden imposed upon reviewing authorities in order for them to be included in the State's SIP. Nevertheless, these options and revisions will ultimately provide greater operational flexibility to sources permitted by the States, which will in turn reduce the overall burden on the program on State and local authorities by reducing the number of required permit modifications. In comparison, no tribal government currently has an approved Tribal Implementation Plan ( TIP)

under the CAA to implement the NSR program. The Federal government is currently the NSR reviewing authority in Indian country. Thus, tribal governments should not experience added burden, nor should their laws be affected with respect to implementation of this rule. Additionally,

although major stationary sources affected by today's rule could be located in or near Indian country and/ or be owned or operated by tribal governments, such affected sources Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 19, 2003 114 would not incur additional costs or compliance burdens as a result of this rule. Instead, the only effect on such sources should be the benefit of the added certainty and flexibility provided by the rule.

The EPA recognizes the importance of including tribal outreach as part of the rulemaking process. In addition to affording tribes an opportunity to comment on this rule through the proposal, on which two tribes did submit comments, we have also alerted tribes of this action through our website and quarterly newsletter. To this point we have not specifically consulted with tribal officials on this rule, but we are committed to work with any tribal government to resolve any issues that we may have overlooked in today's rules and that may have an adverse impact in Indian country.

D. Executive Order 13045  Protection of Children from Environmental Health Risks and Safety Risks Executive Order 13045, " Protection of Children from Environmental Health Risks and Safety Risks" ( 62 FR 19885,

April 23, 1997) applies to any rule that ( 1) is determined to be " economically significant" as defined under Executive Order 12866, and ( 2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 19, 2003 115 action meets both criteria, we must evaluate the environmental health or safety effects of the planned rule on children and explain why the planned regulation is preferable to other potentially effective and reasonable alternatives that we considered.

This rule is not subject to Executive Order 13045,

because we do not have reason to believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. We believe that, based on our analysis of electric utilities, this rule as a whole will result in equal or better environmental protection than currently provided by the existing regulations, and do so in a more streamlined and effective manner.

E. Regulatory Flexibility Act ( RFA), as Amended by the Small Business Regulatory Enforcement Fairness Act of 1996 ( SBREFA), 5 U. S. C. 601 et seq.

We determined it is not necessary to prepare a regulatory flexibility analysis in connection with this final rule. We have also determined that this rule will not have a significant economic impact on a substantial number of small entities. For purposes of assessing the impacts of today's rule on small entities, small entity is defined as:

( 1) any small business employing fewer than 500 employees;

( 2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 19, 2003 116 with a population of less than 50,000; and ( 3) a small organization that is any not for profit enterprise which is independently owned and operated and is not dominant in its field.

After considering the economic impacts of today's rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. In determining whether a rule has a significant economic impact on a substantial number of small entities, the impact of concern is any significant adverse economic impact on small entities, since the primary purpose of the regulatory flexibility analyses is to identify and address regulatory alternatives " which minimize any significant economic impact of this rule on small entities."

5 U. S. C. Sections 603 and 604. Thus, an agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, or otherwise has a positive economic effect on all of the small entities subject to the rule.

Today's rule will not have a significant economic impact on a substantial number of small entities because it will decrease the regulatory burden of the existing regulations and have a positive effect on all small entities subject to the rule. This rule improves operational flexibility for Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 19, 2003 117 owners and operators of major stationary sources and clarifies applicable requirements for determining if a change qualifies as a major modification. We have therefore concluded that today's rule will relieve regulatory burden for all small entities.

F. Unfunded Mandates Reform Act of 1995 Title II of the Unfunded Mandates Reform Act of 1995 ( UMRA), Public Law 104 4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under section 202 of UMRA, we generally must prepare a written statement, including a cost benefit analysis, for proposed and final rules with " Federal mandates" that may result in expenditures to State, local,

and tribal governments, in the aggregate, or to the private sector of $ 100 million or more in any one year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires us to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost effective or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover,

section 205 allows us to adopt an alternative other than the least costly, most cost effective, or least burdensome Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 19, 2003 118 alternative if the Administrator publishes with the final rule an explanation why that alternative was not adopted.

Before we establish any regulatory requirements that may significantly or uniquely affect small governments,

including tribal governments, we must have developed under section 203 of the UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of our regulatory proposals with significant Federal intergovernmental mandates, and informing,

educating, and advising small governments on compliance with the regulatory requirements.

We believe these rule changes will actually reduce the regulatory burden associated with the major NSR program by improving the operational flexibility of owners and operators and clarifying the requirements. Because the program changes provided in the rule are not expected to result in any increases in the expenditure by State, local,

and tribal governments, or the private sector, we have not prepared a budgetary impact statement or specifically addressed the selection of the least costly, most costeffective or least burdensome alternative. Because small governments will not be significantly or uniquely affected Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 19, 2003 119 by this rule, we are not required to develop a plan with regard to small governments. Therefore, this rule is not subject to the requirements of section 203 of the UMRA.

G. National Technology Transfer and Advancement Act of 1995 Section 12( d) of the National Technology Transfer and Advancement Act of 1995 ( NTTAA), Public Law No. 104 113,

section 12( d) ( 15 U. S. C. 272 note) directs us to use voluntary consensus standards ( VCS) in our regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. VCS are technical standards ( for example, materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs us to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable VCS.

Although this rule does involve the use of technical standards, it does not preclude the State, local, and tribal reviewing agencies from using VCS. Today's rule is an improvement of the existing NSR permitting program. As such, it only ensures that promulgated technical standards are considered and appropriate controls are installed, prior to the construction of major sources of air emissions.

Therefore, we are not considering the use of any VCS in today's rule. Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 19, 2003 120 H. Executive Order 13211  Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use This rule is not a " significant energy action" as defined in Executive Order 13211, " Actions Concerning Regulations That Significantly Affect Energy Supply,

Distribution, or Use" ( 66 FR 28355 ( May 22, 2001)) because it is not likely to have a significant adverse effect on the supply, distribution or use of energy.

Today's rule improves the ability of sources to maintain the reliability of production facilities, and effectively utilize and improve existing capacity.

I. Executive Order 12988  Civil Justice Reform This final rule does not have any preemptive or retroactive effect. This action meets applicable standards in sections 3( a) and 3( b)( 2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity,

and reduce burden.

V. Effective Date for Today's Requirements All of these changes will take effect in the Federal PSD program ( codified at § 52.21) on [ INSERT DATE 60 DAYS AFTER DATE OF PUBLICATION OF FINAL RULES IN THE FEDERAL REGISTER]. This means that these rules will apply on [ INSERT DATE 60 DAYS AFTER DATE OF PUBLICATION OF FINAL Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 19, 2003 121 RULES IN THE FEDERAL REGISTER] in any area without an approved PSD program, for which we are the reviewing authority, or for which we have delegated our authority to issue permits to a State or local reviewing authority.

To be approvable under the SIP, State and local agency programs implementing part C ( PSD permit program in § 51.166)

or part D ( nonattainment NSR permit program in § 51.165) must include today's changes as minimum program elements. State and local agencies should assure that any program changes under § § 51.165 and 51.166 are consistently accounted for in other SIP planning measures. State and local agencies must adopt and submit revisions to their part 51 permitting programs implementing these minimum program elements no later than [ INSERT DATE 3 YEARS AFTER PUBLICATION OF FINAL REGULATION IN FEDERAL REGISTER]. That is, for both nonattainment and attainment areas, the SIP revisions must be adopted and submitted within 3 years from today. The Act does not specify a date for submission of SIPs when we revise the PSD and NSR rules. We believe it is appropriate to establish a date analogous to the date for submission of new SIPs when a NAAQS is promulgated or revised. Under section 110( a)( 1) of the Act, as amended in 1990, that date is 3 years from promulgation or revision of the NAAQS.

Accordingly, we have established 3 years from today's revisions as the required date for submission of conforming Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 19, 2003 122 SIP revisions. We have made conforming changes to the PSD regulations at § 51.166( a)( 6)( i) to indicate that State and local agencies must adopt and submit plan revisions within 3 years after new amendments are published in the Federal Register.

Today's rule revises the Federal PSD program located at 40 CFR 52.21 to include the new equipment replacement provision of the RMRR exclusion. The part 52 regulations governing Federal permitting programs include the Federal PSD rule at 40 CFR 52.21 as well as the various sections of subparts C through DDD of part 52 that incorporate the Federal permitting program by reference for those jurisdictions where EPA applies part 52.21 as a Federal Implementation Plan because such jurisdictions lack an approved SIP to implement the PSD program. Because today's final rule adds additional paragraphs to the part 52.21 rules, we will be revising the references in subparts C through DDD to appropriately reflect the program that applies. This final action will be taken in a separate Federal Register notice and will not change the effective date of today's final changes.

VI. Statutory Authority The statutory authority for this action is provided by sections 101, 111, 114, 116, and 301 of the CAA as amended Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 19, 2003 123 ( 42 U. S. C. 7401, 7411, 7414, 7416, and 7601). This rulemaking is also subject to section 307( d) of the CAA ( 42 U. S. C. 7407( d)). Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 19, 2003 124 RMRR   Page ?? of ??(?)

LIST OF SUBJECTS 40 CFR Parts 51 and 52 Environmental protection, Administrative practices and procedures, Air pollution control, Intergovernmental relations.

____________________

Dated:

_____________________

Marianne Lamont Horinko,

Acting Administrator.


[Federal Register Volume 76, Number 12 (Wednesday, January 19, 2011)]
[Notices]
[Pages 3145-3146]
[FR Doc No: 2011-997]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0611]

Pediatric Device Consortia Grant Program (P50)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of grant funds for the support of the Office of Orphan
Products Development (OOPD) Pediatric Device Consortia Grant Program.
The goal of the Pediatric Device Consortia Grant Program is to promote
pediatric device development by providing grants to nonprofit consortia
whose business model and approach to device development will either
result in, or substantially contribute to, market approval of medical
devices designed specifically for use in children. The program does not
support the development of single device projects. Although
administered by the Office of Orphan Products Development, this grant
program is intended to encompass devices that could be used in all
pediatric conditions or diseases, not just rare diseases. The pediatric
population (neonates, infants, children, and adolescents) includes
patients who are 21 years of age or younger at the time of diagnosis or
treatment.

DATES: Important dates are as follows:
    1. The application due date is May 2, 2011.
    2. The anticipated start date is September, 2011.
    3. The opening date is January 15, 2011.
    4. The expiration date is May 3, 2011.
    For Further Information and Additional Requirements Contact:
    Linda C. Ulrich or Debra Y. Lewis, Office of Orphan Products
Development, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg 32, rm. 5271, Silver Spring, MD 20993-0002,<PHONE_NUMBER> or
Camille Peake, Office of Acquisitions & Grant Services, Food and Drug
Administration, 5630 Fishers Lane, rm. 2139, Rockville, MD 20852, 301-
827-7175.
    For more information on this funding opportunity announcement (FOA)
and to obtain detailed requirements, please refer to the full FOA when
posted and located at: http://grants.nih.gov/grants/guide/index.html.

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

    RFA-FD-011-002.
    Catalog of Federal Domestic Assistance Number: 93.103.

A. Background

    The development of pediatric medical devices currently lags 5 to 10
years behind the development of devices for adults. Children differ
from adults in terms of their size, growth, development, and body
chemistry,

adding to the challenges of pediatric device development. There
currently exists a great need for medical devices designed specifically
with children in mind. Such needs include the original development of
pediatric medical devices, as well as the specific adaptation of
existing adult devices for children. Thus, as part of the Food and Drug
Administration Amendments Act of 2007 (FDAAA), Congress passed the
Pediatric Medical Device Safety and Improvement Act of 2007. Section
305 of FDAAA requires the Secretary of Health and Human Services to
provide demonstration grants or contracts to nonprofit consortia to
promote pediatric device development.

B. Research Objectives

    The goal of FDA's Pediatric Device Consortia Grant Program is to
promote pediatric device development by providing grants to nonprofit
consortia. The consortia will facilitate the development, production,
and distribution of pediatric medical devices by: (1) Encouraging
innovation and connecting qualified individuals with pediatric device
ideas with potential manufacturers; (2) mentoring and managing
pediatric device projects through the development process, including
product identification, prototype design, device development, and
marketing; (3) connecting innovators and physicians to existing Federal
and non-Federal resources; (4) assessing the scientific and medical
merit of proposed pediatric device projects; and (5) providing
assistance and advice as needed on business development, personnel
training, prototype development, post-marketing needs, and other
activities.

C. Eligibility Information

    The grants are available to any domestic, public or private,
nonprofit entity (including State and local units of government).
Federal agencies that are not part of the Department of Health and
Human Services (HHS) may apply. Agencies that are part of HHS may not
apply. Organizations that engage in lobbying activities, as described
in section 501(c)(4) of the Internal Revenue Code of 1968, are not
eligible to receive grant awards.

II. Award Information/Funds Available

A. Award Amount

    Approximately $2.5 million will fund two to four new awards. Grants
will be awarded up to $1,500,000 in total cost (direct costs plus
indirect costs) per year.

B. Length of Support

    Grants will be awarded on a competitive basis for up to 2 years.

III. Paper Application, Registration, and Submission Information

    To submit a paper application in response to this FOA, applicants
should first review the full announcement when posted and located at
http://grants.nih.gov/grants/guide/index.html. (The FDA has verified
the Web site addresses throughout this document, but FDA is not
responsible for any subsequent changes to the Web sites after this
document publishes in the Federal Register). Persons interested in
applying for a grant may obtain an application at http://grants.nih.gov/grants/funding/phs398/phs398.html. For all paper
application submissions, the following steps are required:
     Step 1: Obtain a Dun and Bradstreet (DUNS) Number.
     Step 2: Register With Central Contractor Registration.
    Steps 1 and 2, in detail, can be found at http://www07.grants.gov/applicants/organization_registration.jsp. After you have followed
these steps, submit paper applications to: Division of Acquisition
Support and Grants, Office of Acquisition & Grant Services, 5630
Fishers Lane, rm. 2128, Rockville, MD 20857,<PHONE_NUMBER>.

    Dated: January 13, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-997 Filed 1-18-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 88, Number 118 (Wednesday, June 21, 2023)]
[Rules and Regulations]
[Pages 40065-40071]
[FR Doc No: 2023-13156]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2023-0670; Project Identifier AD-2022-01427-T;
Amendment 39-22463; AD 2023-12-05]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is superseding Airworthiness Directive (AD) 2022-03-
05, which applied to all The Boeing Company Model 747-8F and 747-8
series airplanes and Model 777 airplanes. AD 2022-03-05 required

revising the limitations section of the existing airplane flight manual
(AFM) to incorporate limitations prohibiting dispatching or releasing
to airports, and approaches or landings on runways, when in the
presence of interference from wireless broadband operations in the 3.7-
3.98 GHz frequency band (5G C-Band) as identified by Notices to Air
Missions (NOTAMs). Since the FAA issued AD 2022-03-05, the FAA
determined that additional limitations are needed due to the continued
deployment of new 5G C-Band stations whose signals are expected to
cover most of the contiguous United States at transmission frequencies
between 3.7-3.98 GHz. This AD requires revising the limitations section
of the existing AFM to incorporate limitations prohibiting dispatching
or releasing to airports, and approaches or landings on runways, due to
the presence of 5G C-Band interference. The FAA is issuing this AD to
address the unsafe condition on these products.

DATES: This AD is effective June 21, 2023.

ADDRESSES: AD Docket: You may examine the AD docket at regulations.gov
under Docket No. FAA-2023-0670; or in person at Docket Operations
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this final rule, any comments
received, and other information. The address for Docket Operations is
U.S. Department of Transportation, Docket Operations, M-30, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Brett Portwood, Continued Operational
Safety Technical Advisor, COS Program Management Section, Operational
Safety Branch, FAA, 3960 Paramount Boulevard, Lakewood, CA 90712-4137;
phone:<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 to supersede AD 2022-03-05, Amendment 39-21922 (87 FR 4150,
January 27, 2022) (AD 2022-03-05). AD 2022-03-05 applied to all The
Boeing Company (Boeing) Model 747-8F and 747-8 series airplanes and
Model 777 airplanes equipped with a radio altimeter. The NPRM published
in the Federal Register on May 3, 2023 (88 FR 27799). The NPRM was
prompted by a determination that radio altimeters cannot be relied upon
to perform their intended function if they experience interference from
wireless broadband operations in the 5G C-Band, and a determination
that this interference may affect other airplane systems using radio
altimeter data, including the pitch control laws, including those that
provide tail strike protection, regardless of the approach type or
weather.
    In the NPRM, the FAA proposed to retain the AFM revisions required
by AD 2022-03-05 until June 30, 2023. On or before June 30, 2023, the
FAA proposed to require replacing those AFM revisions with limitations
prohibiting dispatching or releasing to airports, and approaches or
landings on runways, in the contiguous U.S. airspace for non-radio
altimeter tolerant airplanes. For radio altimeter tolerant airplanes,
the FAA proposed to allow the prohibited operations at 5G C-Band
mitigated airports (5G CMAs) as identified in an FAA Domestic Notice.
The FAA proposed this AD to address missing or erroneous radio
altimeter data, which, in combination with multiple flight deck
effects, could lead to loss of continued safe flight and landing.

Discussion of Final Airworthiness Directive

Comments

    The FAA provided the public with an opportunity to comment on the
proposed AD and received comments from five commenters. The following
presents the comments received on the NPRM and the FAA's response to
each comment.

Support for NPRM

    Boeing and the Air Line Pilots Association, International (ALPA),
supported the NPRM without change.
    The supportive comments from ALPA included additional viewpoints
without a suggestion specific to the AD or a request the FAA can act
on. These comments are outside the scope of this AD.

Request for Additional AMOC Relief

    Comment summary: All Nippon Airways (All Nippon) requested the FAA
revise the proposed AD to allow AMOCs approved for AD 2023-10-02,
Amendment 39-22438 (88 FR 34065, May 26, 2023) (AD 2023-10-02) as AMOCs
for this AD.
    FAA response: The FAA does not agree. An airplane that is a radio
altimeter tolerant airplane for purposes of AD 2023-10-02 will also be
a radio altimeter tolerant airplane for purposes of this AD. However,
because the hazards mitigated by AD 2023-10-02 are separate and
distinct from the hazards mitigated by this AD, the FAA has determined
that AMOCs approved for compliance with AD 2023-10-02 may not always be
appropriate to address the unsafe condition specified in this AD. For
this reason, operators with an approved AMOC for AD 2023-10-02 will
need to request approval of it as an AMOC for compliance with this AD.

Request To Extend Compliance Time

    Comment summary: American Airlines expressed concern regarding the
compliance time for the proposed actions and requested the FAA revise
the AD to provide a minimum of 30 days from the effective date of the
AD.
    FAA response: The FAA understands the commenter's concern and made
every effort to publish this AD as soon as possible. After refraining
from operating at their FCC-authorized levels for a year and a half,
wireless companies are now able to operate at higher levels, yet still
not at the levels authorized. Specifically, wireless companies expect
to operate their networks in urban areas with minimal restrictions due
to the completion of retrofits. Additionally, the FAA anticipates 19
additional telecommunication companies will begin transmitting in the
C-Band after June 30, 2023. Although the FAA continues to work with the
companies that intend to transmit in the 3.7-3.98-GHz band near 5G
CMAs, the FAA has no agreement with those companies to provide the FAA
with tower locations and other information necessary to support the
current NOTAM/AMOC process. Therefore, the FAA will not be able to
extend the June 30, 2023, date.

Request for List of Compliant Radio Altimeters

    Comment summary: All Nippon requested the FAA clarify how to
determine whether a radio altimeter (for example, LRA-900 P/N 822-0334-
004) corresponds to a radio altimeter tolerant airplane or non-radio
altimeter tolerant airplane. An individual requested the FAA revise the
AD to add the list of the part numbers for compliant radio altimeters
(e.g., Collins LRA-900+ and THALES ERT-530R).
    FAA response: The FAA does not maintain a list of tolerant radio
altimeters because the determination of a radio altimeter tolerant
airplane must consider the installation details, which vary from
airplane to airplane. The FAA has developed a policy statement that
provides a means of compliance with this AD for all transport and
commuter category airplanes and rotorcraft equipped with a radio
altimeter. The FAA requested public comments on this proposed policy on
May 8, 2023 (88 FR

29554). The proposed policy describes an acceptable framework and
method for demonstrating that an airplane or rotorcraft is radio
altimeter tolerant. The policy discusses compliance methods that should
be applied to programs for type certificates, amended type
certificates, STCs, and amended STCs. The proposed policy addresses how
to assess 5G C-Band tolerance. Although most data submitted to
demonstrate compliance in accordance with the FAA policy statement will
be proposed by design approval holders, any person/entity can propose a
method to demonstrate compliance.

Request To Clarify Restrictions at Non-CMAs

    Comment summary: All Nippon and an individual requested the FAA
clarify why the proposed AD would prohibit radio altimeter tolerant
airplanes from landing at non-5G CMAs after July 2023. All Nippon
stated that there are many non-5G CMAs that are unaffected by 5G C-Band
interference and operations should not be restricted at such airports.
    FAA response: The FAA disagrees. Boeing has not submitted any
substantiating data that demonstrates the hazards addressed by this AD
are adequately mitigated for radio altimeter tolerant airplanes at non-
5G CMAs.

Conclusion

    The FAA reviewed the relevant data, considered any comments
received, and determined that air safety requires adopting this AD as
proposed. Accordingly, the FAA is issuing this AD to address the unsafe
condition on these products. This AD is adopted as proposed in the
NPRM.

Interim Action

    The FAA considers this AD to be an interim action. Once the
Technical Standard Order (TSO) standard for radio altimeters is
established, which will follow the existing international technical
consensus on the establishment of the minimum operational performance
standards (MOPS), the FAA anticipates that the MOPS will be
incorporated into the TSO. Once a new radio altimeter TSO is developed,
approved, and available, the FAA might consider additional rulemaking.

Effective Date

    Section 553(d) of the Administrative Procedure Act (APA) (5 U.S.C.
551 et seq.) requires publication of a rule not less than 30 days
before its effective date. However, section 553(d) authorizes agencies
to make rules effective in less than 30 days when the agency finds
``good cause.'' Radio altimeters cannot be relied upon to perform their
intended function if they experience interference from wireless
broadband operations in the 5G C-Band. This interference may affect
other airplane systems using radio altimeter data, including the pitch
control laws, including those that provide tail strike protection,
regardless of the approach type or weather, which, in combination with
multiple flight deck effects, could lead to loss of continued safe
flight and landing. To address this unsafe condition, the actions
required by this AD must be accomplished before the compliance date of
June 30, 2023. The FAA based this date on the changes to the 5G C-Band
environment beginning on July 1, 2023. These changes include increased
wireless broadband deployment and transmissions closer to the
parameters authorized by the FCC. The earlier operators learn of the
requirements in this AD, the earlier they can take action to ensure
compliance. An effective date less than 30 days would ensure the AD is
codified earlier, thereby increasing awareness of its requirements.
Therefore, the FAA finds that good cause exists pursuant to 5 U.S.C.
553(d) for making this amendment immediately effective.

Costs of Compliance

    The cost information below describes the costs to change the AFM.
Although this AD largely maintains the AFM limitations currently
required by AD 2022-03-05, the FAA acknowledges that this AD may also
impose costs on some aircraft operators from having to change their
conduct to comply with the amended AFM. However, the FAA lacks the data
necessary to quantify the costs associated with aircraft operators
changing their conduct.
    The FAA estimates that this AD affects 347 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
AFM revision (retained action from AD   1 work-hour x $85 per                 $0             $85         $29,495
 2022-03-05).                            hour \1\ = $85.
New AFM revision (new required action)  1 work-hour x $85 per                  0              85      \2\ 29,495
                                         hour = $85.
----------------------------------------------------------------------------------------------------------------
\1\ The labor rate of $85 per hour is the average wage rate for an aviation mechanic.
\2\ The estimated cost for this revision would not constitute a significant economic impact (even for small
  entities) because $85 is a minimal cost compared to the regular costs of maintaining and operating a Model 747-
  8F, 747-8, or 777 transport category airplane.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by:
0
a. Removing Airworthiness Directive (AD) 2022-03-05, Amendment 39-21922
(87 FR 4150, January 27, 2022), and
0
b. Adding the following new AD:

2023-12-05 The Boeing Company: Amendment 39-22463; Docket No. FAA-
2023-0670; Project Identifier AD-2022-01427-T.

(a) Effective Date

    This airworthiness directive (AD) is effective June 21, 2023.

(b) Affected ADs

    This AD replaces AD 2022-03-05, Amendment 39-21922 (87 FR 4150,
January 27, 2022) (AD 2022-03-05).

(c) Applicability

    This AD applies to all The Boeing Company airplanes identified
in paragraphs (c)(1) and (2) of this AD, certificated in any
category.
    (1) Model 747-8F and 747-8 series airplanes.
    (2) Model 777-200, -200LR, -300, -300ER, and 777F series
airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 34, Navigation.

(e) Unsafe Condition

    This AD was prompted by a determination that radio altimeters
cannot be relied upon to perform their intended function if they
experience interference from wireless broadband operations in the
3.7-3.98 GHz frequency band (5G C-Band), and a determination that
this interference may affect other airplane systems using radio
altimeter data, including the pitch control laws, including those
that provide tail strike protection, regardless of the approach type
or weather. The FAA is issuing this AD to address missing or
erroneous radio altimeter data, which, in combination with multiple
flight deck effects, could lead to loss of continued safe flight and
landing.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Definitions

    (1) For purposes of this AD, a ``5G C-Band mitigated airport''
(5G CMA) is an airport at which the telecommunications companies
have agreed to voluntarily limit their 5G deployment at the request
of the FAA, as identified by an FAA Domestic Notice.
    (2) For purposes of this AD, a ``radio altimeter tolerant
airplane'' is one for which the radio altimeter, as installed,
demonstrates the tolerances specified in paragraphs (g)(2)(i) and
(ii) of this AD, using a method approved by the FAA.
    (i) Tolerance to radio altimeter interference, for the
fundamental emissions (3.7-3.98 GHz), at or above the power spectral
density (PSD) curve threshold specified in figure 1 to paragraph
(g)(2)(i) of this AD.
BILLING CODE 4910-13-P

Figure 1 to paragraph (g)(2)(i)--Fundamental Effective Isotropic PSD
at Outside Interface of Aircraft Antenna
[GRAPHIC] [TIFF OMITTED] TR21JN23.087

    (ii) Tolerance to radio altimeter interference, for the spurious
emissions (3.7-3.98 GHz), at or above the PSD curve threshold
specified in figure 2 to paragraph (g)(2)(ii) of this AD.

    Figure 2 to paragraph (g)(2)(ii)--Spurious Effective Isotropic
PSD at Outside Interface of Aircraft Antenna
[GRAPHIC] [TIFF OMITTED] TR21JN23.088

    (3) For purposes of this AD, a ``non-radio altimeter tolerant
airplane'' is one for which the radio altimeter, as installed, does
not demonstrate the tolerances specified in paragraphs (g)(2)(i) and
(ii) of this AD.

(h) Retained Airplane Flight Manual (AFM) Revision

    This paragraph restates the requirements of paragraph (g) of AD
2022-03-05. Within 2 days after January 27, 2022 (the effective date
of AD 2022-03-05): Revise the Limitations Section of the existing
AFM to include the information specified in figure 3 to paragraph
(h) of this AD. This may be done by inserting a copy of figure 3 to
paragraph (h) of this AD into the existing AFM.

    Figure 3 to paragraph (h)--AFM Limitations Revisions
    [GRAPHIC] [TIFF OMITTED] TR21JN23.089

(i) New Requirement: AFM Revision for Non-Radio Altimeter Tolerant
Airplanes

    For non-radio altimeter tolerant airplanes, do the actions
specified in paragraphs (i)(1) and (2) of this AD.
    (1) On or before June 30, 2023, revise the Limitations Section
of the existing AFM to include the information specified in figure 4
to paragraph (i) of this AD. This may be done by inserting a copy of
figure 4 to paragraph (i) of this AD into the existing AFM.
Incorporating the AFM revision required by this paragraph terminates
the AFM revision required by paragraph (h) of this AD.
    (2) Before further flight after incorporating the limitations
specified in figure 4 to paragraph (i) of this AD, remove the AFM
revision required by paragraph (h) of this AD.

Figure 4 to paragraph (i)--AFM Revision for Non-Radio Altimeter
Tolerant Airplanes
[GRAPHIC] [TIFF OMITTED] TR21JN23.090

(j) New Requirement: AFM Revision for Radio Altimeter Tolerant
Airplanes

    For radio altimeter tolerant airplanes, do the actions specified
in paragraphs (j)(1) and (2) of this AD.
    (1) On or before June 30, 2023, revise the Limitations Section
of the existing AFM to include the information specified in figure 5
to paragraph (j) of this AD. This may be done by inserting a copy of
figure 5 to paragraph (j) of this AD into the existing AFM.
Incorporating the AFM revision required by this paragraph terminates
the AFM revision required by paragraph (h) of this AD.
    (2) Before further flight after incorporating the limitations
specified in figure 5 to paragraph (j) of this AD, remove the AFM
revision required by paragraph (h) of this AD.

Figure 5 to paragraph (j)--AFM Revision for Radio Altimeter Tolerant
Airplanes
[GRAPHIC] [TIFF OMITTED] TR21JN23.091

(k) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Operational Safety Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or responsible Flight
Standards Office, as appropriate. If sending information directly to
the manager of the Operational Safety Branch, send it to the
attention of the person identified in paragraph (l) of this AD.
Information may be emailed to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the responsible Flight Standards Office.
    (3) AMOCs approved for AD 2021-23-12, Amendment 39-21810 (86 FR
69984, December 9, 2021), providing relief for specific radio
altimeter installations are approved as AMOCs for the requirements
specified in paragraph (h) of this AD until June 30, 2023.

(l) Related Information

    For more information about this AD, contact Brett Portwood,
Continued Operational Safety Technical Advisor, COS Program
Management Section, Operational Safety Branch, FAA, 3960 Paramount

Boulevard, Lakewood, CA 90712-4137; phone:<PHONE_NUMBER>; email:
[email protected].

(m) Material Incorporated by Reference

    None.

    Issued on June 9, 2023.
Michael Linegang,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-13156 Filed 6-16-23; 11:15 am]
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[Federal Register Volume 79, Number 20 (Thursday, January 30, 2014)]
[Notices]
[Pages 4896-4897]
[FR Doc No: 2014-01871]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13570-002]

Warm Springs Irrigation District: Notice of Application Accepted
for Filing and Soliciting Motions To Intervene and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Application for New License for a Major
Water Project 5 Megawatts (MW) or Less--Existing Dam.
    b. Project No.: 13570-002.
    c. Date filed: April 15, 2013.
    d. Applicant: Warm Springs Irrigation District.
    e. Name of Project: Warm Springs Dam Hydroelectric Project.
    f. Location: On the Malheur River, near the Town of Juntura,
Malheur County, Oregon. The project would utilize the existing Warm
Springs dam and reservoir, which is owned by the U.S. Bureau of
Reclamation (Reclamation) and would occupy 13.5 acres of land
administered by the U.S. Bureau of Land Management.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Mr. Randy Kinney, Warmsprings Irrigation
District, 334 Main Street North, Vale, OR 97918,<PHONE_NUMBER>.
    i. FERC Contact: Ken Wilcox,<PHONE_NUMBER>;
<EMAIL_ADDRESS>    j. Deadline for filing motions to intervene and protests: 60 days
from the issuance date of this notice.
    The Commission strongly encourages electronic filing. Please file
filing motions to intervene and protests using the Commission's eFiling
system at http://www.ferc.gov/docs-filing/efiling.asp. For assistance,
please contact FERC Online Support at<EMAIL_ADDRESS>(866)
208-3676 (toll free), or<PHONE_NUMBER> (TTY). In lieu of electronic
filing, please send a paper copy to: Secretary, Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426. The
first page of any filing should include docket number P-13570-002.
    The Commission's Rules of Practice and Procedures require all
intervenors filing documents with the Commission to serve a copy of
that document on each person on the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    k. This application has been accepted for filing, but is not ready
for environmental analysis at this time.
    l. The proposed project would utilize the existing Reclamation's
Warm Springs Dam and reservoir, and would consist of the following new
facilities: (1) A new steel liner fitted into one of the outlets; (2)
new trashrack at the entrance to the existing outlet works; (3) a 3.5-
foot-long, 6-to-8-foot-diameter steel increaser section attached to the
liner to transition the outlet into an 8-foot-diameter steel penstock;
(4) a 150-foot-long increaser/penstock assembly to convey water to the
new powerhouse located in the stilling basin below the dam; (5) a new
4-foot-diameter fixed cone bypass valve upstream of the powerhouse; (6)
a 150-foot-long, 8-foot-diameter steel penstock; (7) a powerhouse
containing one 2.7-MW Francis or Kaplan turbine; (8) a 2.2-mile-long,
25-kilovolt transmission line; and (9) appurtenant facilities. The
average annual generation is estimated to be 7.442 gigawatt-hours.
    m. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC Online Support. A copy is also available for inspection and
reproduction at the address in item h above.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    n. Any qualified applicant desiring to file a competing application
must submit to the Commission, on or before the specified intervention
deadline date, a competing development application, or a notice of
intent to file such an application. Submission of a timely notice of
intent allows an interested person to file the competing development
application no later than 120 days after the specified intervention
deadline date. Applications for preliminary permits will not be
accepted in response to this notice.
    A notice of intent must specify the exact name, business address,
and telephone number of the prospective applicant, and must include an
unequivocal statement of intent to submit a development application. A
notice of intent must be served on the applicant(s) named in this
public notice.
    Anyone may submit a protest or a motion to intervene in accordance
with

the requirements of Rules of Practice and Procedure, 18 CFR 385.210,
385.211, and 385.214. In determining the appropriate action to take,
the Commission will consider all protests filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any protests or motions to
intervene must be received on or before the specified deadline date for
the particular application.
    When the application is ready for environmental analysis, the
Commission will issue a public notice requesting comments,
recommendations, terms and conditions, or prescriptions.
    All filings must (1) bear in all capital letters the title
``PROTEST'' or ``MOTION TO INTERVENE,'' ``NOTICE OF INTENT TO FILE
COMPETING APPLICATION,'' or ``COMPETING APPLICATION;'' (2) set forth in
the heading the name of the applicant and the project number of the
application to which the filing responds; (3) furnish the name,
address, and telephone number of the person protesting or intervening;
and (4) otherwise comply with the requirements of 18 CFR 385.2001
through 385.2005. Agencies may obtain copies of the application
directly from the applicant. A copy of any protest or motion to
intervene must be served upon each representative of the applicant
specified in the particular application.

    Dated: January 24, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-01871 Filed 1-29-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 114 (Thursday, June 15, 2017)]
[Notices]
[Pages 27512-27513]
[FR Doc No: 2017-12432]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0655]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Animal Generic Drug
User Fee Act Cover Sheet

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by July
17, 2017.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0632.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Form FDA 3728, Animal Generic User Fee Act Cover Sheet--21 U.S.C. 379j-
21--OMB Control Number 0910-0632--Extension

    Section 741 of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 379j-21) establishes three different kinds of user
fees: (1) Fees for certain types of abbreviated applications for
generic new animal drugs; (2) annual fees for certain generic new
animal drug products; and (3) annual fees for certain sponsors of
abbreviated applications for generic new animal drugs and/or
investigational submissions for generic new animal drugs (21 U.S.C.
379j-21(a)). Because concurrent submission of user fees with
applications is required, the review of an application cannot begin
until the fee is submitted. Form FDA 3728 is the Animal Generic Drug
User Fee Act (AGDUFA) Cover Sheet, which is designed to collect the
minimum necessary information to determine whether a fee is required
for review of an application, to determine the amount of the fee
required, and to account for and track user fees. The form, when
completed electronically, will result in the generation of a unique
payment identification number used by FDA to track the payment. It will
be used by FDA's Center for Veterinary Medicine and FDA's Office of
Financial Management to initiate the administrative screening of new
generic animal drug applications to determine if payment has been
received.
    In the Federal Register of September 2, 2016 (81 FR 60707), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
                Form FDA No.                    Number of      responses per     Total annual         Average burden per response          Total hours
                                               respondents       respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
3728.......................................              20                2               40   .08 (5 minutes)........................             3.2
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Respondents to this collection of information are new generic
animal drug applicants. Based on Agency data for the past 3 years, FDA
estimates there are approximately 40 submissions annually and a total
of 3.2 burden hours. The burden for this information collection has not
changed since the last OMB approval.

    Dated: June 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12432 Filed 6-14-17; 8:45 am]
 BILLING CODE 4164-01-P