Federal Register Vol. 82, No.116,

Section 203(c) of the Agricultural Marketing Act of 1946, as amended (7 U.S.C. 1621 et seq.), directs and authorizes the Secretary of Agriculture “to develop and improve standards of quality, condition, quantity, grade, and packaging and recommend and demonstrate such standards in order to encourage uniformity and consistency in commercial practices.” AMS is committed to carrying out this authority in a manner that facilitates the marketing of agricultural commodities. While the beef standards do not appear in the Code of Federal Regulations, they—along with other official standards—are maintained by USDA at https://www.ams.usda.gov/grades-standards. Copies of official standards are also available upon request. To propose changes to the beef standards, AMS utilizes the procedures it published in the August 13, 1997, Federal Register, and that appear in 7 CFR part 36.

The beef standards and associated voluntary, fee-for-service beef grading service program are authorized under the Agricultural Marketing Act of 1946, as amended. The primary purpose of official USDA grade standards is to divide the population of a commodity into uniform groups (of similar quality, yield, value, etc.) to facilitate marketing. The USDA's voluntary, fee-for-service grading programs are designed to provide an independent, objective determination as to whether a given product is in conformance with the applicable official standard. When beef is voluntarily graded to the beef standards under the grading service, the official grade consists of a quality grade and/or a yield grade.

The quality grades are intended to identify differences in the palatability or eating satisfaction of cooked beef principally through the characteristics of marbling and physiological maturity groupings. As noted in the standards referenced above, the principal official USDA quality grades for young (maturity groups “A” and “B”) cattle and carcasses are Prime, Choice, and Select, in descending order in terms of historic market value. USDA recognizes that the beef standards must be relevant in order to be of greatest value to stakeholders and, therefore, recommendations for changes in the standards may be initiated by USDA or by interested parties at any time to achieve that goal.

For beef, USDA quality grades provide a simple, effective means of describing product that is easily understood by both buyers and sellers. By identifying separate and distinct segments of beef, grades enable buyers to obtain the particular kind of beef that meets their individual needs. For example, certain restaurants may choose to only sell officially graded USDA Prime beef so as to provide their customers with a product that meets a very consistent level of overall palatability. At the same time, grades are important in transmitting information to cattle producers to help ensure informed production, feeding, and marketing decisions are made. For example, the market preference and price paid for a particular grade of beef is communicated to cattle producers so they can adjust their production accordingly. In such a case, if the price premium being paid for a grade, such as USDA Prime beef, merits producers making the investments required in cattle genetics and feeding to produce more USDA Prime beef, such marketing decisions can be made with justification.

Since its inclusion in the beef standards, physiological maturity based on skeletal and muscular evidence has been the means for establishing age of animals in both marketing standards and in research. USDA graders examine signs of physiological maturity (e.g., size, shape, and ossification of the bones and cartilages—especially the split chine bones—and color, texture, and firmness of the lean flesh) in order to assign a maturity grouping. Although never intended to be a definitive method to determine the chronological age of cattle at the time of slaughter and instead utilized to predict beef palatability, the maturity groupings have historically been roughly correlated to different age ranges and categories: Maturity grouping A was correlated with beef from cattle between 9 and 30 months of age (MOA) at time of slaughter, maturity grouping B was correlated with beef from cattle between 30 and 42 MOA at time of slaughter, maturity grouping C was correlated with beef from cattle between 42 and 72 MOA at time of slaughter, maturity grouping D was correlated with beef from cattle between 72 and 96 MOA at time of slaughter, and maturity grouping E was correlated with beef from cattle more than 96 MOA at time of slaughter. However, these are rough approximations that are influenced by other factors including sex, nutrition, growth promotant administration, reproductive status, breed, and a variety of other environmental factors. Therefore, cattle that are younger than 30 MOA may have a physiological maturity grouping of B or greater due to the factors listed above.

Generally, A-maturity carcasses are eligible for Prime, Choice, Select, and Standard quality grades; B-maturity carcasses are eligible for Prime, Choice, or Standard; and C-, D-, or E-maturity carcasses are eligible for Commercial, Utility, Cutter, or Canner. In most fed beef plants, carcasses that fit the C-, D-, or E-maturity categories (often referred to as “hard bones”) are not presented for USDA grading.

The beef standards have had past revisions made to the maturity grouping requirements, and these revisions resulted in classifications that were designed to reduce the variability of eating quality within the grades. The most recent such change occurred in 1997 when certain carcasses from the B-maturity grouping were no longer eligible for the USDA Select quality grade. The official standards have never relied upon any other indicator besides physiological maturity to determine maturity grouping or the resulting USDA quality grade. This was primarily because the use of physiological maturity was not intended to be used to predict the age of an animal at time of slaughter but rather the resulting palatability of the meat.

Many years of research have demonstrated a correlation between physiological maturity and beef palatability, and the factors affecting the physiological maturity of a beef animal are numerous. It is well-documented that elevated levels of estrogen, found in heifers and heiferettes (females that have calved once), result in advanced skeletal ossification. Estrogen is also higher in those animals being administered growth implants containing estrogen and estrogen-like compounds and possibly those animals fed and exposed to naturally occurring estrogens in their diet. Animals having an elevated exposure to estrogen are much more likely to result in B- or C-maturity carcasses, and this advanced skeletal maturity is more prevalent the closer the animal is to 30 MOA.

The scientific literature also indicates that the meat in younger cattle contains immature and soluble collagen that when cooked does not negatively impact the tenderness of the product. As an animal matures, the collagen will become more mature and have more thermally stable cross-links, resulting in a tougher product. However, when grain-finished cattle are evaluated at various ages (12 to 35 months) and skeletal maturities (A to C), the resulting differences in tenderness are minimal. Scientific studies support this phenomenon, explained by the faster turnover of both the muscle fibers and the connective tissue within the animal due to faster growth and higher concentrate diets. An overview of many of these factors is discussed by Tatum, 2011.1

Although not used as part of the voluntary grading process, dentition has been used in the U.S. since 2004 by the USDA's Food Safety and Inspection Service (FSIS) in all federally inspected plants to determine whether an animal is less than or older than 30 MOA. FSIS Directive 6100.4 explains that “[i]nspection program personnel are to consider cattle to be 30 months and older when the examination of the dentition of the animal shows that at least one of the second set of permanent incisors (I2) has erupted above the gum line.” Cattle older than 30 MOA must have certain specified risk materials, such as the vertebral column, removed from their carcasses before the sale of the resulting beef cuts. In addition to the visual inspection of permanent incisors, FSIS personnel will accept documentation showing the actual age of the animal. Age verification involves providing the proper paperwork or other proof of an animal's actual age (e.g., less than 30 MOA) and is also used for a variety of purposes, including meeting foreign market requirements for U.S. beef from cattle under a certain age.

Current research has indicated that carcasses from grain-fed steers and heifers that are identified as less than 30 MOA based on dentition are similar in palatability to A-maturity carcasses determined via physiological maturity and thus could be classified A-maturity for grading purposes even though the physiological maturity characteristics of B- or older maturity groupings may be present. When comparisons involve grain-finished steers and heifers that are less than 30 MOA, the age of the animal has been shown to have little effect on beef tenderness. In addition, numerous studies have evaluated the relationship between the skeletal maturity of an animal and its dentition pattern. In two experiments, described by Lawrence et al., 2001, 1,464 cattle were evaluated for physiological maturity and dentition characteristics.2 These studies showed that 97.5 percent of cattle with 2 permanent incisors (the cutoff point for less than 30 MOA) were classified as A-maturity carcasses. In that study, the authors suggest that dentition is a more accurate determinant of carcass maturity, although they have no evidence that dentition is better able to predict palatability. This is supported by other research showing that dentition is more closely related to actual chronological age than is physiological maturity.

Two recent studies funded by the Cattlemen's Beef Promotion and Research Board evaluated the relationship between eating quality and the skeletal maturity of carcasses that were classified by dentition as either less than 30 MOA or greater than 30 MOA. The first study 3 (Acheson et. al., 2014) sampled 450 grain-finished steer and heifer carcasses classified as less than 30 MOA through dentition, with varying skeletal maturity and marbling scores. Trained sensory panels and slice shear force (SSF) testing were conducted and neither analysis determined a difference between steaks from the A-maturity versus the B- through C-maturity carcasses. Marbling categories were effective in stratifying carcasses according to differences in tenderness and juiciness. Results from that study suggest A-C-maturity carcasses have similar sensory and SSF scores when they originate from grain-finished cattle classified as less than 30 MOA by dentition.

The second study 4 (Semler et. al., 2016) evaluated the tenderness of steaks from 600 steer and heifer carcasses that varied in marbling, skeletal maturity, and age by dentition. Tenderness was also evaluated by trained sensory panels and SSF testing. The results were consistent with those from the first study and showed that the tenderness between USDA maturity classifications (A versus B-D) was not different within dental age (less than 30 MOA or greater than 30 MOA). Steaks from carcasses greater than 30 MOA did have more intense grassy and bloody/serum flavors and decreased tenderness within the slight degree of marbling group. As in the first study, the degree of marbling was effective in stratifying carcasses according to differences in tenderness and juiciness.

On April 13, 2016, representatives from the National Cattlemen's Beef Association, the National Association of State Departments of Agriculture, the U.S. Meat Export Federation, and the American Farm Bureau Federation petitioned USDA to amend the beef standards. The petition to amend the beef standards (the petition) seeks to amend them by allowing age verification or dentition-based assessment to determine carcass maturity in fed steers and heifers. Both the petition and associated research are available at https://www.ams.usda.gov/grades-standards/beef-request-for-comments.

In consideration of the body of research, the petition requested that USDA revise the beef standards by adding the following language to section 54.104(k) of the beef standards that describes the skeletal maturity:

The petition stated that approximately 7.2 percent of cattle classified as less than 30 months of age exhibit premature skeletal ossification, and so rather than qualifying as A-maturity (the youngest maturity classification in the beef standards), they qualify as B-maturity or older and are subject to discounts that reduce the overall value of the carcass.

AMS was also provided a large data set from a recent study of beef packing plant slaughter and performed a statistical and economic analysis on the data to determine the possible impact should the proposed change to the beef standards be adopted. The results of this review were published in a May 19, 2016, document, “Economic Assessment of the Request to Modernize the U.S. Standards for Grades of Carcass Beef”, and is available at the aforementioned Web site. The study period ranged from the beginning of May 2014 through the end of April 2015. Extrapolating the study data across the total population of cattle graded each year by AMS—approximately 21 million—resulted in the following:

• Seventy-two percent were slaughtered in facilities participating in the study;

• Ninety-seven percent were found to be less than 30 MOA using dentition;

• Less than 3 percent (2.8) were found to be equal to or greater than 30 MOA;

• Less than 2 percent (1.68) were deemed to be age-discounted when using skeletal ossification as the measure of maturity grouping; and

• Less than one-half of 1 percent of the total cattle graded were age-verified.

According to the study, had there been an allowance to use dentition as a means to override physiological characteristics of advanced maturity grouping, as was proposed, roughly an additional 1 percent of those cattle would have been eligible for grading. Of these cattle, 4.5 percent would have been graded Prime, 63.6 percent Choice, and 31.9 percent Select. Within the Choice category, 24.4 percent of all newly graded carcasses would have been placed in the top two-thirds Choice category (branded Choice programs), and 39.2 percent of all added carcasses would have been placed in the bottom of the Choice category. In addition, lean and skeletal maturity requirements are referenced throughout many of the current USDA Certified Beef Programs and the General Schedules. Upon request, USDA provides certification of meat carcasses for a number of marketing programs that make claims concerning breed and carcass characteristics. If the proposed changes to the beef standards are made, users of these certified programs should evaluate their specifications closely and recommend any needed changes to USDA.

The grade composition of the carcasses being added by using dentition as a measure of age was not much different than the grade composition of carcasses graded using physiological maturity, and overall, these data show an increase of 1.05 percent for Prime beef, 0.91 percent for Choice, and 1.29 percent for Select. According to calculations made from wholesale beef elasticity, wholesale beef prices could decline between 1 to 1.5 percent for each of the grade categories as a result of the increased supply of graded beef. Using this data, AMS found a net gain to producers of nearly $55 million, primarily due to reduced hard bone discounts for quality grade maturity grouping done by the current physiological maturity approach alone.

This information was published by USDA in a Notice in the Federal Register (81 FR 57877) on August 24, 2016, which sought public comment on whether or not to amend the beef standards. AMS received 236 total comments. Of those comments, 179 commenters favored revising the beef standards to include dentition and documented age as additional methods for maturity classification. There were 53 commenters who did not support making the changes. Two comments were submitted in duplicate and one comment was submitted in triplicate; each of these respective submissions was counted only once. It is noteworthy that 160 of the 179 favorable comments were the same form letter and were from producers. Comments can be viewed at https://www.regulations.gov/document?D=AMS-LPS-16-0060-0001.

The vast majority of comments were received from the producer segment of the industry. Commenters who supported the changes cited an anticipated increase in the number of carcasses that would qualify for USDA grades of Prime, Choice, and Select without a significant reduction in palatability for those grades; the anticipated profitability producers would gain by having carcasses grade or grade higher; and support for the science-based Cattlemen's Beef Promotion and Research Board-funded research. Many agricultural associations, which represent a majority of cattle producers, provided favorable comments in support of the changes. In addition, most major packing companies provided positive comments in support of the changes. The potential increase in Prime and Choice carcasses, along with premiums to the producers, were the primary factors cited for their support.

Commenters opposed to changing the beef standard identified various issues of concern, and these are further discussed below. Although there were 53 individual comments that did not support a revision to the beef standards, many responses raised multiple issues. Therefore, as we examine each category of concern, the total figures mentioned will exceed a sum of 53. Seventeen commenters believed the populations in the referenced studies were too small. In response, AMS has determined that all studies referenced herein—including those that found that carcasses exhibiting advanced skeletal maturity when determined by dentition to be under 30 MOA produced meat that was as palatable in taste tests as meat produced from carcasses that did not exhibit signs of advanced skeletal maturity—were peer-reviewed and adequately designed to answer the study objectives and hypotheses. Statistical significance and statistical power of the test will in fact increase with an increased sample size, in small increments, but add significant costs.

There were 24 commenters who questioned the value of dentition in predicting age, and 1 commenter pointed out that the beef standards are not designed to predict age, but instead palatability. In response, AMS notes that recent research suggests that dentition is a more accurate determinant of carcass maturity and is more closely related to actual chronological age than is USDA physiological maturity. As briefly discussed above, studies by Lawrence showed that 97.5 percent of cattle with 2 permanent incisors (the cutoff point for less than 30 MOA) were classified as A-maturity carcasses.

One commenter suggested that a change to the beef standards was not warranted given the relatively small percentage of cattle (and subsequent carcasses) affected by the change. While the economic study performed by USDA shows an approximate potential increase of 1 percent in the Choice and Prime categories, AMS believes this is a significant value proposition for both the beef production and processing sectors. USDA is not proposing this change because of the number of cattle that will be affected or the economic benefit. Instead, USDA is proposing to revise the beef standards because current scientific research has presented another acceptable means for determining the maturity of a beef carcass.

Thirteen commenters expressed concern about the dentition process overseen by FSIS and the perceived lack of training for the employees responsible for this procedure. FSIS has clear guidelines and procedures for the evaluation of dentition on cattle, and this procedure has been ongoing for many years with little to no concerns being raised by domestic or international users of U.S. beef products. Several of these commenters also suggested that, while they believe FSIS is properly overseeing the dentition process through trained plant personnel, they believe AMS must have involvement in the process if that dentition determination will ultimately become a factor in the application of a voluntary USDA grade. In response to this concern, AMS would require that plants provide their procedures for marking and identification of cattle greater than 30 MOA. AMS would also verify these procedures are being adhered to through a Quality Systems Assessment audit or other means. AMS is also proposing a procedure and change to the standard that would allow the AMS grader to refrain from grading an under-30-MOA carcass that exhibits advanced skeletal maturity (e.g., D- and E-skeletal maturity). While this may occur infrequently, providing a procedure for AMS graders to evaluate advanced skeletal carcasses that are identified as under 30 MOA protects the grading system and ensures that carcasses exhibiting advanced skeletal maturity never qualify for Prime, Choice, Select, or Standard.

Twenty commenters suggested that these changes would cheapen U.S. beef. It is important to note that the majority of grain-finished cattle are harvested at 12 to 24 MOA and usually produce A-maturity beef. In other words, the vast majority of cattle offered for grading will not be affected at all by this proposed change. That said, a percentage of carcasses that today are evaluated as B- or C-maturity but are produced from cattle under 30 MOA would be eligible for grading under the proposed system. Based on AMS's estimates outlined in “Economic Assessment of the Request to Modernize the U.S. Standards for Grades of Carcass Beef,” roughly an additional 1 percent of cattle would be eligible for grading. The research outlined here does not show any trends towards an inferior product being produced if dentition is implemented.

Lastly, 15 commenters raised concerns over how the proposed changes would be implemented and differ from current practices. Implementing the use of dentition in plants for the determination of beef quality grades would require minimal changes to an AMS grader's day-to-day activities. There may be plant-specific requirements and changes needed regarding the identification procedures for carcasses less than 30 MOA and greater than 30 MOA, but these procedures are currently being carried out in-plant. Carcasses deemed less than 30 MOA would be sorted and the grader would then perform his or her normal marbling assessment to apply the final quality grade. Consistent with the current practices, any carcasses deemed greater than 30 MOA would be marked by the plant and graded by an AMS grader using skeletal and lean characteristics to determine maturity and then marbling.

In consideration of the approximately three-fourths of commenters who supported revising the beef standards, as well as the research supporting their modernization, USDA is issuing this Notice outlining proposed changes. These changes would allow dentition and documentation of actual age to be used to classify beef carcasses as A-maturity and determine eligibility for all quality grade classifications, with the exception of those carcasses exhibiting advanced skeletal maturity traits (as described for D- and E-maturity).

USDA proposes to provide additional oversight of the dentition process used to classify carcasses as either less than 30 MOA or greater than 30 MOA. FSIS approves plant personnel to examine the dentition and FSIS inspectors to monitor the process to ensure carcasses greater than 30 MOA have been correctly identified. However, because this process would now be instrumental to the subsequent application of a USDA quality grade, AMS personnel must have knowledge of the process including marking and identification techniques for cattle greater than 30 MOA. AMS would review this process on a regular basis through an existing Quality System Assessment audit or other means. In many beef packing plants, AMS already reviews the dentition process as part of an export verification audit and the applicant makes these procedures available to the USDA grader.

USDA proposes to allow carcasses identified as less than 30 MOA through dentition or actual documented age (through an approved USDA Process Verified Program or Quality System Assessment Program) to qualify for the USDA Prime, Choice, Select and Standard grades, regardless of skeletal and lean characteristics. This proposal means that for carcasses deemed less than 30 MOA, the amount and distribution of marbling will become the primary characteristics for determining the final USDA quality grade. Carcasses identified as greater than 30 MOA through dentition are eligible for all USDA grades, with application of skeletal and lean characteristics factored in the determination, as currently described in the beef standards.

USDA is not proposing any changes to the requirements for carcasses exhibiting dark cutting lean, regardless of age verification method. Carcasses exhibiting dark cutting lean will be graded as currently described in the beef standards.

Proposed amendments to the beef standards are described below:

1. Amend 54.104 by revising paragraph (k) to read as follows:

(k) For steer, heifer, and cow beef, quality of the lean is evaluated by considering its marbling, color, and firmness as observed in a cut surface, in relation to carcass evidences of maturity. The maturity of the carcass is determined through one of three methods:

(1) Dentition as monitored by the Food Safety and Inspection Service (FSIS). Carcasses determined to be less than 30 months of age (MOA) will be classified as A-maturity, and with the exception of dark cutting lean characteristics, the final quality grade will be determined by the degree of marbling. Any carcasses under 30 MOA exhibiting advanced skeletal maturity traits (as described for D- and E-maturity) will not be eligible for the Prime, Choice, Select, or Standard grades and will be graded according to their skeletal, lean, and marbling traits accordingly;

(2) Documentation of age as verified through USDA-approved programs and by FSIS at the slaughter facility. Carcasses determined to be less than 30 MOA by age verification will be classified as A-maturity and, with the exception of dark cutting lean characteristics, the final quality grade will be determined by the degree of marbling. Any carcasses under 30 MOA exhibiting advanced skeletal maturity traits (as described for D- and E-maturity) will not be eligible for the Prime, Choice, Select, or Standard grades and will be graded according to their skeletal, lean, and marbling traits accordingly; or

(3) Through evaluation of the size, shape, and ossification of the bones and cartilages, especially the split chine bones, and the color and texture of the lean flesh. Carcasses determined to be greater than 30 MOA will be eligible for all quality grade classifications with the final quality grade being determined by the evaluation of the degree of marbling and any adjustment factors based on advanced skeletal maturity characteristics. In the split chine bones, ossification changes occur at an earlier stage of maturity in the posterior portion of the vertebral column (sacral vertebrae) and at progressively later stages of maturity in the lumbar and thoracic vertebrae. The ossification changes that occur in the cartilages on the ends of the split thoracic vertebrae are especially useful in evaluating maturity and these vertebrae are referred to frequently in the standards. Unless otherwise specified in the standards, whenever reference is made to the ossification of cartilages on the thoracic vertebrae, this shall be construed to refer to the cartilages attached to the thoracic vertebrae at the posterior end of the forequarter. The size and shape of the rib bones are also important considerations in evaluating differences in maturity. In the very youngest carcasses considered as “beef,” the cartilages on the ends of the chine bones show no ossification, cartilage is evident on all of the vertebrae of the spinal column, and the sacral vertebrae show distinct separation. In addition, the split vertebrae usually are soft and porous and very red in color. In such carcasses, the rib bones have only a slight tendency toward flatness. In progressively more mature carcasses, ossification changes become evident first in the bones and cartilages of the sacral vertebrae, then in the lumbar vertebrae, and still later in the thoracic vertebrae. In beef that is very advanced in maturity, all the split vertebrae will be devoid of red color and very hard and flinty, and the cartilages on the ends of all the vertebrae will be entirely ossified. Likewise, with advancing maturity, the rib bones will become progressively wider and flatter, which is shown in very mature beef whose ribs will be very wide and flat.

Background

Under the regulations in “Subpart—Plants for Planting” (7 CFR 319.37 through 319.37-14, referred to below as the regulations), the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA) prohibits or restricts the importation of plants for planting (including living plants, plant parts, seeds, and plant cuttings) to prevent the introduction of quarantine pests into the United States. Quarantine pest is defined in § 319.37-1 as a plant pest or noxious weed that is of potential economic importance to the United States and not yet present in the United States, or present but not widely distributed and being officially controlled.

The regulations in § 319.37-2a provide for the listing of plants for planting whose importation is not authorized pending pest risk analysis (NAPPRA) in order to prevent the introduction of quarantine pests into the United States. Those regulations establish two lists of taxa whose importation is NAPPRA: A list of taxa of plants for planting that are quarantine pests, and a list of taxa of plants for planting that are hosts of quarantine pests. For taxa of plants for planting that have been determined to be quarantine pests, the list includes the names of the taxa, which will be NAPPRA from all countries and regions. For taxa of plants for planting that are hosts of quarantine pests, the list includes the names of the taxa, the foreign places from which the taxa's importation is not authorized, and the quarantine pests of concern.

Paragraph (b) of § 319.37-2a describes the process for adding taxa to the NAPPRA lists. In accordance with that process, we published a notice 1 in the Federal Register on May 6, 2013 (78 FR 26316-26317, Docket No. APHIS-2012-0076) that announced our determination that 22 taxa of plants for planting are quarantine pests and 37 taxa of plants for planting are hosts of 9 quarantine pests. That notice also made available datasheets that detail the scientific evidence we evaluated in making the determination that the taxa are quarantine pests or hosts of a quarantine pest.

We solicited comments concerning the notice and the datasheets for 60 days ending July 5, 2013. We reopened and extended the deadline for comments until August 12, 2013, in a document published in the Federal Register on July 12, 2013 (78 FR 41908). We received 26 comments by that date. They were from producers, importers, industry groups, representatives of State and foreign governments, and private citizens. They are discussed below by topic.

One commenter expressed concern regarding the quality of scientific literature used to justify the listing of taxa to the NAPPRA category, citing a perceived lack of original evidence and data. The commenter further stated that the Center for Plant Health Science Technology (CPHST) of APHIS' Plant Protection and Quarantine (PPQ) program must be involved in literature reviews and the process to remove taxa from the NAPPRA list.

The literature searches used to develop the NAPPRA datasheets are designed to determine whether the pest of concern qualifies as a quarantine pest, that damage to U.S. agriculture and/or the environment is likely from introduction of the quarantine pest, and that the hosts of the listed quarantine pest are natural hosts and not artificially or laboratory induced. The types of references used were defined in the original NAPPRA rule, and included such review articles as those produced by the European and Mediterranean Plant Protection Organization and the Weed Science Society of America, both well-respected pest description and management organizations. Review articles provide stakeholders with information to determine the damage potential of the pest, nomenclature, and its quarantine status. These reviews provide references to scientific articles used to justify a taxon's inclusion on the NAPPRA list. All datasheets for NAPPRA listing are reviewed by qualified PPQ staff, including CPHST staff. CPHST staff have also been involved in the review of NAPPRA datasheets and will be involved in the event of removal of plant taxa from the NAPPRA category. Within CPHST, the science and technology division is responsible for conducting pest risk assessments (PRA). The purpose of the PRA is to determine the risk of quarantine pests following the pathway and to develop appropriate phytosanitary measures that reduce the pest risk to an acceptable level.

Several commenters stated that the United States should seek greater harmonization with Canada in terms of regulated taxa and countries of origin for regulated taxa. One commenter stated this is especially important due to the possibility of transshipment when a taxon is prohibited from all places except Canada.

To the greatest extent possible, we are working towards harmonizing our NAPPRA listings with those of Canada. For example, APHIS exempts particular plant taxa from Canada from NAPPRA if Canada is free of the quarantine pest for which the plants are hosts and when Canada's import regulations are harmonized with those of the United States or when Canada has significant trade history with the United States in a particular taxa. However, some differences will probably always exist due to differences in national priorities and acceptable levels of protection with respect to certain pests. While transshipment remains a concern when an exporter is not truthful about the origin of the plant material being moved, third country plants that have entered Canada that are on the NAPPRA list of the United States are prohibited from ever being exported to the United States and vice versa. APHIS relies on the national plant protection organization (NPPO) of Canada as well as other NPPOs to prevent unauthorized transshipments just as we rely on exporters to truthfully state the origin of shipments.

One commenter stated that, for many of the taxa listed in the May 2013 notice, the taxa originate in the United States and are grown in Canada. Therefore, the commenter stated that these plants should be eligible for re-export to the United States without the burden of a required PRA.

While taxa may have been exported only from the United States, there is the possibility that they may have been exposed to pests of concern by being commingled with other taxa of either Canadian origin or third country origin that have NAPPRA status for the United States. Therefore, we believe a PRA is necessary for such taxa before being re-exported to the United States.

One commenter stated that a Federal order should not be used to list taxa on the NAPPRA list without first conducting a formal PRA.

When we find evidence that the importation of a taxon of plants for planting that is currently being imported poses a risk of introducing a quarantine pest, we restrict or prohibit its importation through the issuance of a Federal import quarantine order, also referred to as a Federal order. The information and restrictions in the Federal order for plants for planting are based on a technical evaluation document that contains the same information found in the NAPPRA datasheet. The Federal order is used to rapidly take action to prevent the introduction of a quarantine pest, and is generally followed by notice and an opportunity for public comment. If comments present information that leads us to determine that the importation of the taxon does not pose a risk of introducing a quarantine pest into the United States, APHIS will rescind the Federal order and not add the taxon to the NAPPRA list.

Certain taxa that are hosts of quarantine pests are exempt from NAPPRA listing when there is “significant trade” between the exporting country and the United States. We defined significant trade as the importation of 10 or more plants of a taxon in each of the previous 3 fiscal years. However, one commenter suggested that, due to ebbs and flows in importation, significant trade should instead be defined as the importation of 10 or more plants for 3 of the last 5 or 10 years. The commenter also suggested that plant taxa imported under a current Departmental permit or a controlled import permit (CIP) be either exempt from NAPPRA listing or count toward the 10 or more threshold for determining significant trade.

We are open to reconsidering how we define significant trade. However, if we were to consider the commenter's suggestion for redefining significant trade as the importation of 10 or more plants for 3 out of 5 years, we would most likely also consider raising the base number of plants from 10 to a higher level to differentiate trade from random imports. Imports under a Departmental permit or CIP are not counted toward the 10 or more threshold for determining significant trade because these imports are generally prohibited taxa and are not available for general import. While these imports are likely to continue, they must adhere to additional conditions or mitigations to reduce pest risk.

One commenter stated that banning plants from a country with no scientific evidence that it harbors the quarantine pest of concern does not satisfy the APHIS requirement of “necessity” and that the datasheets used to place a taxon on the NAPPRA list must provide scientific evidence that the excluded countries are likely to harbor the pest. Several commenters stated that certain taxa from specific countries should be exempted from NAPPRA listing because the pest of concern is not present in that country and/or the host plant has not been a source of pest introductions. Some commenters requested that, if exemption could not be accomplished, a more thorough review of the literature used to justify listing the taxa be undertaken.

Our policy in implementing the NAPPRA category is to prevent the importation of hosts from any country, regardless of current pest status, with the following exceptions: (1) Taxa of hosts of quarantine pests whose importation we proposed to allow to continue under a Federal order; (2) hosts of quarantine pests currently being imported from a country in which the pest is not present; and (3) taxa from countries with significant trade in those taxa with the United States. If a country has significant trade in a taxon that is a host of a quarantine pest, we undertake measures other than addition to the NAPPRA category to address the risk associated with that taxon when such measures are available. In general, it is appropriate to add hosts of quarantine pests from all countries to the NAPPRA category because pests can spread quickly from country to country through the movement of plants for planting, and the importation of plants for planting is a high-risk pathway for the introduction of quarantine pests. For taxa that have not previously been imported, we are following International Plant Protection Convention guidelines by requiring a PRA prior to the importation of a plant taxon from a new country or region. As mentioned previously, the datasheets used to justify adding a taxon to the NAPPRA category already include a literature review that establishes the scientific evidence that the taxon is either a quarantine pest or a host of a quarantine pest. The datasheets also take into account available import history as evidence of significant trade in the taxon between the exporting country and the United States in order to make NAPPRA policy decisions. A country may submit copies of issued phytosanitary certificates as evidence of significant import history to demonstrate that a pest of concern is not present in that country and/or a taxon has not been a source of pest introductions.

Several commenters asked that certain taxa from specific countries be exempted from NAPPRA listing due to significant trade in those taxa between the exporting country and the United States or because the taxa are currently being imported under a Departmental permit or CIP.

If sufficient data can be provided for APHIS to verify that significant trade exists, we will consider amending the datasheet and publishing a Federal Register notice indicating the host plant may be imported from a particular country without being subject to a PRA. For example, based on additional information presented after the publication of the NAPPRA final notice published on April 18, 2013, we have determined that the import history for Hibiscus spp. from Denmark meets the threshold for significant trade. Based on comments received on the May 2013 notice, we have determined that Annona, Camellia, Cercidiphyllum, and Pennisetum spp. from Canada also meet the threshold for significant trade. Therefore, we are exempting Hibiscus spp. from Denmark and Annona, Camellia, Cercidiphyllum, and Pennisetum spp. from Canada from NAPPRA listing. The importation of taxa under a Departmental permit or CIP is not considered to be trade because the taxa are not subject to the same restrictions as commercial shipments of taxa.

One commenter stated that many of the listed taxa are produced under controlled conditions, including clean stock programs and rigorous phytosanitary conditions, and that it is in the interest of the producer/distributor to ensure that plants and seed are free of pests and diseases prior to export. Two commenters asked if there could be some way to continue shipments of host taxa with the added assurance of a survey or testing regime to determine freedom from specific quarantine pests.

If an exporting country does not have enough of an import history with the United States to qualify for the significant trade exemption, they can request that a PRA be conducted that would identify possible pest and disease mitigations. Such mitigations may include clean stock programs or a rigorous surveillance regime.

One commenter stated that data collection must be improved and that if a taxon is placed on the NAPPRA list as a result of faulty data, the error must be quickly and transparently corrected to prevent disruption to trade. The commenter further stated that a plant taxon must be removed from the NAPPRA category if a mitigation is presented that addresses the quarantine pest that justified the taxon's inclusion on the NAPPRA list. The commenter also asked for clarification on the process by which stakeholders may contact APHIS to remove a taxon erroneously added to the NAPPRA list.

The identification of trade that was not recorded in our import databases is one of the purposes of publishing proposed NAPPRA candidates in the Federal Register for public comment. This information is utilized to make adjustments to host/country combinations placed on NAPPRA. If a taxon has been determined to have been added to the NAPPRA list erroneously, stakeholders may submit evidence in support of that conclusion during the NAPPRA notice's comment period. They may also submit that information to the program contact(s) listed in the Federal Register notice. As stated previously, a PRA may be conducted to identify possible pest and disease mitigations for a taxon that has been determined to be the host of a quarantine pest. Under these mitigations, a taxon may be imported into the United States.

One commenter stated that APHIS should avoid the “precautionary principle,” which the commenter described as prohibiting the broad importation of taxa until proof of no or low risk is determined. The commenter cites the prohibition of all species of a plant genus when only a subset or a single species of that genus has been found to be associated with a pathogen.

When a plant is added to the NAPPRA list, a datasheet is prepared containing scientific evidence that the plant is a host of a plant pest or pathogen of quarantine significance, or that the plant itself is a pest of quarantine significance. It has been APHIS' policy to regulate hosts of quarantine pests at the genus level for decades. When a new species is identified as a host, additional scientific studies will often identify other host species within that genus. Therefore, regulating all species within the genus is the preferred course of action until a PRA is conducted. As noted previously, we are not prohibiting the importation of taxa on the NAPPRA list indefinitely. NAPPRA listing only requires that a PRA be conducted to remove host plants from NAPPRA listing and to ensure that all quarantine pests that may follow that pathway are appropriately mitigated prior to importation.

One commenter stated that APHIS must include industry in the NAPPRA process in order for the process to be successful. However, the commenter also stated that industry does not have the capacity to review the literature sources used to justify a taxon's inclusion on the NAPPRA list and should not be required to do so. One commenter stated that they would like the opportunity to work on joint pest risk assessments with APHIS to increase the ability to respond to pest threats.

APHIS has always welcomed industry cooperation in its programs and would especially welcome the expertise, knowledge, and overseas experience of industry members in identifying quarantine pests, their distribution, natural hosts, and potential mitigations that would allow for the continued importation of hosts from established trading partners. APHIS does not require stakeholders to review literature sources. However, if contradictory scientific information is known but not considered in the data sheet, then this information should be presented as a public comment. If a stakeholder does not have access to the sources cited in the literature review, copies can be made available upon request. We release draft PRAs on the APHIS Web site for stakeholder consultation prior to their publication.

Two commenters expressed concern about the amount of time it takes to complete a PRA, stating that this results in taxa being prohibited unnecessarily and that APHIS should look for better and faster ways of conducting PRAs. One commenter stated that requiring a PRA is likely to be expensive to the exporting industry as well as causing a significant time delay.

We strive to complete all PRAs in a timely manner. However, the length of time it takes to complete a PRA is dependent on several factors, some of which are not in APHIS' control:

• The availability of data on the taxon;

• The timeliness with which the foreign NPPO responds to our requests for information; and

• The prioritization of APHIS' limited resources available for developing PRAs.

If a foreign country wishes to be able to conduct trade in a taxon with the United States, we would expect that its NPPO would provide information to APHIS in a timely manner, thus helping to reduce the time necessary to complete the PRA and any expenses resulting from a delay. Industry could help foreign NPPOs by working with them to assemble and provide the necessary information. We do not anticipate that requiring a PRA would result in significant expense to the exporting industry, as we do not require the importer to pay money to complete a PRA. In addition, importers that have established a history of significant trade in a taxon will be able to continue importing that taxon without interruption.

One commenter asked why we took public comment on the taxa listed in the May 2013 notice because these taxa will be included in a future comprehensive revision to the plants for planting regulations (§§ 319.37 through 319.37-14) where public comment will also be solicited.

The revision to the plants for planting regulations is merely a restructuring of the current regulations by moving specific restrictions on the importation of taxa to the Plants for Planting Manual. It also adds a framework for integrated pest management measures. However, that revision does not change any specific restrictions on the movement of taxa on the NAPPRA list. Therefore, it is more appropriate to address public comments regarding the May 2013 NAPPRA notice in this document.

Several commenters expressed concern that the addition of taxa to the NAPPRA lists could have a negative impact on the U.S. industry by making it difficult to access new plant varieties.

The fundamental underlying principle of NAPPRA is to safeguard U.S. agriculture with the least possible effect on trade. While there is the possibility that the addition of taxa to the NAPPRA lists may make it more difficult to access new plant varieties, the negative impact that it could have on U.S. industry is outweighed by the devastating effect the introduction of quarantine pests into the United States could have on U.S. agriculture. Taxa added to the NAPPRA list are only prohibited entry to the United States if they are determined to be quarantine pests or until a PRA is conducted that has identified appropriate mitigation measures to prevent the introduction of quarantine pests for which they are hosts. In addition, an importer may apply for a CIP to import small quantities of a prohibited or restricted taxon for developmental purposes.

We made available datasheets detailing the scientific evidence we considered in making the determination that 22 taxa of plants for planting are quarantine pests and 37 are hosts of 9 quarantine pests. The comments are discussed below by taxon.

Abies, Larix, Picea, and Pinus. One commenter asked why the importation of Abies, Larix, Picea, and Pinus is restricted only for those plants imported from Europe and Japan when these genera, which are hosts of Dendroctonus micans, are being imported from other countries where D. micans is known to occur.

While the commenter is correct that Abies, Larix, Picea, and Pinus spp. were not included on the NAPPRA list in the May 2013 notice, this is because those genera were already prohibited entry in either the April 2013 NAPPRA notice or in previous rulemaking. The regulations currently prohibit the importation of Abies spp. from all countries except Canada, while Larix, Picea, and Pinus spp. were added to the NAPPRA list in the April 2013 NAPPRA notice. Therefore, it was not necessary to relist Abies, Larix, Picea, and Pinus spp. in the May 2013 NAPPRA notice.

Callistephus. One commenter stated that chrysanthemum stem necrosis virus (CSNV) is not likely to enter the United States from Canada on Callistephus plants because Canada is free of the pathogen; imports of Callistephus plants to Canada are only from the United States, which is free of the pathogen; and propagation is via seed, which is not known to carry the pathogen.

In the May 2013 NAPPRA notice, we added Callistephus, Chrysanthemum, and Eustoma spp. to the NAPPRA list because they have been proven to be hosts for CSNV. Due to additional information received since publication of the previous notice, we have decided to remove all three genera from the NAPPRA list while we conduct a commodity import evaluation document (CIED) for Chrysanthemum. We will address CSNV in that CIED and release the results of the analysis when it is complete.

Camellia. One commenter stated that the pest datasheets supporting the listing of Camellia under NAPPRA are problematic because they base that rationale on one paper and a British PRA, both of which do not provide adequate scientific justification that Camellia is a host of Phytophthora kernoviae.

The paper referred to by the commenter was written by Dr. Clive Brasier, a well-known and respected authority on the genus Phytophthora who also discovered and named the new taxon P. kernoviae. Based on this expertise, we consider this reference scientifically adequate. The datasheet does not cite the PRA mentioned by the commenter as a reference documenting Camellia as a host for P. kernoviae. Camellia is already listed as NAPPRA from all countries, except Canada, for citrus longhorned beetle (Anoplophora chinensis, CLB) and is also regulated for P. ramorum. Therefore, removing Camellia from the NAPPRA list as a host of P. kernoviae would not remove this taxon from the NAPPRA list.

Cercidiphyllum. One commenter asked why importations of Cercidiphyllum from the Netherlands are not listed as NAPPRA. The commenter stated that Asian longhorned beetle (Anoplophora glabripennis, ALB) has been discovered there and that plants from the Netherlands are high risk due to that country's practices of importing large plants in soil and consolidating plants.

Based upon significant import history, Cercidiphyllum from the Netherlands is excluded from the NAPPRA list. However, a Federal order published on May 9, 2013, and effective on May 20, 2013 (DA-2013-18) established mitigations for countries, including the Netherlands, where ALB and CLB are present. Cercidiphyllum from the Netherlands is enterable into the United States only under the conditions of the CLB/ALB Federal order.

Chrysanthemum. Several commenters objected to the temporary hold on importations of Chrysanthemum plants for planting from all countries except Canada. In particular, the commenters objected to the hold on importations of Chrysanthemum from the Netherlands due to the presence in that country of CSNV. One commenter stated that a hold on imports of Chrysanthemum should not be applied to countries where the distribution of CSNV is unknown. Two commenters stated that the screening and certification process for CSNV in the Netherlands is sufficient to detect the pathogen and that CSNV has either not been found within mother plants from production areas within the country or that CSNV is not present within the European Union, of which the Netherlands is a part. Therefore, the commenters state that the risk of introducing CSNV to the United States via Chrysanthemum breeding stock from the Netherlands is minimal and that Chrysanthemum growers within the United States will be harmed by not having access to new cultivars. One commenter stated that free trade and competition will be harmed, leading to a monopoly that will eventually harm the flower industry.

We agree with many of the commenters on the need to look at the Chrysanthemum regulations in general. As stated previously, we are therefore removing Chrysanthemum from the NAPPRA list and conducting a CIED for Chrysanthemum. CSNV disease will be addressed in that evaluation. We will release the results of that analysis when it is completed.

On August 3, 2012, APHIS published an advanced notice of proposed rulemaking 2 in the Federal Register to solicit public comment on whether and how we should amend our process for responding to domestic chrysanthemum white rust (CWR) outbreaks and the importation of plant material that is a host of CWR. One commenter stated that we should let this process continue before taking further regulatory action. The commenter also stated that, if this is not possible, the NAPPRA provisions should only be applied to chrysanthemum imports from Brazil, Iran, and Japan for the immediate future. The commenter further stated that excluding cut flowers from the NAPPRA restrictions is not based on sound science because cut flowers can also be hosts for CSNV.

The CIED we are conducting for chrysanthemum will also address CWR.

One commenter asked that the genus Chrysanthemum be included on the NAPPRA list and a PRA conducted to assess the risk of introducing CSNV on chrysanthemum cuttings.

As mentioned above, we are removing Chrysanthemum from the NAPPRA list while we conduct a CIED. The CIED will address CSNV.

One commenter asked that APHIS provide advance notice to industry when new regulations are approved in order to minimize trade disruptions for chrysanthemum growers.

Any changes to our regulations regarding Chrysanthemum as a result of the CIED will be communicated to the industry prior to going into effect.

Eucalyptus. One commenter asked that the ban on eucalyptus plants from Australia be lifted, but did not present any evidence for why the ban is unfounded.

We are not making any changes based on this comment.

Fagus and Ilex. In the datasheets accompanying the May 2013 NAPPRA notice, we inadvertently omitted the Netherlands from the list of countries authorized to export Fagus and Ilex species. Those omissions have been corrected.

Hedera. One commenter asked for a more thorough review of the literature justifying the NAPPRA listing of the genus Hedera. The commenter stated that there appears to be no scientific justification for listing Hedera as a natural host of P. kernoviae other than a statement that stem necrosis has been observed. Two commenters stated that Hedera spp. have been imported from Denmark and the Netherlands without pest problems and that this should preclude NAPPRA listing of Hedera due to its presence in trade.

We would be happy to review any additional literature sources or other scientific information presented by the commenters to support their objection to listing Hedera. However, Hedera was added to the NAPPRA list via the NAPPRA notice published in April 2013 and is currently regulated under NAPPRA as a host of CLB. It is only authorized for importation into the United States from certain countries. We inadvertently omitted one of those countries, Kenya, from the list of countries authorized for importation in the datasheets made available with the May 2013 NAPPRA notice. We are correcting that omission in this notice.

Pennisetum. One commenter stated that exports of Pennisetum spp. from Canada should be exempt from NAPPRA restrictions for Indian peanut clump and peanut clump viruses because Canada is free from these pathogens of concern, all propagative material imported from Canada originates either in Canada or the United States, and there has been ongoing trade of Pennisetum spp. between the United States and Canada for several years.

Based upon significant trade history documented by the NPPO of Canada since publication of the May 2013 NAPPRA notice, we have determined Pennisetum from Canada meets the threshold to be considered exempt from NAPPRA listing. As with Pennisetum, additional documentation from the NPPO of Canada has also confirmed significant trade history in Annona, Camellia, and Cercidiphyllum spp. between Canada and the United States. Therefore, these genera from Canada will also be exempt from NAPPRA listing.

Vaccinium. Several commenters expressed concern regarding the addition of the genus Vaccinium to the NAPPRA list. One commenter stated that the NAPPRA listing of Vaccinium from all countries except Canada and Australia would create a competitive disadvantage for U.S. growers who would be unable to access the latest Vaccinium varieties. One commenter stated that, since Vaccinium spp. are already subject to a quarantine period of two growing seasons following importation, imports of Vaccinium spp. should only be excluded from countries where P. kernoviae is known to occur. The commenter requested that, if Vaccinium cannot be excluded from the NAPPRA listing, small quantities be allowed to be imported for evaluation and plant breeding purposes under a CIP stating the plants will be maintained under quarantine and tested for the presence of P. kernoviae in cooperation with USDA inspectors.

Vaccinium spp. are not consistently being exported from any country except Canada and Australia. Therefore, we do not believe adding Vaccinium to the NAPPRA list for all countries except Canada and Australia would negatively impact U.S. growers. However, we are not indefinitely prohibiting Vaccinium spp. or any other host taxon from importation through NAPPRA. Host taxa (genus or species) listed as NAPPRA only require a PRA before trade in those taxa can be initiated to ensure that all quarantine pests of the host that may follow this pathway are appropriately mitigated. An importer may also apply for a CIP to import small quantities of a prohibited or restricted taxon for experimental or developmental purposes provided that adequate pest mitigation measures can be identified and implemented.

Two commenters stated that APHIS should remove Vaccinium from the NAPPRA list as a host of P. kernoviae because the data sheet used to add Vaccinium to the NAPPRA list does not provide evidence that the entire genus is a host of the pathogen. The commenters stated that the pathogen justifying the prohibition of Vaccinium spp., P. kernoviae, has only been associated with a single Vaccinium species, V. myrtillus (bilberry), and that the pathogen has only been found in the United Kingdom, Ireland, and New Zealand. Therefore, only bilberry from those countries should be added to the NAPPRA list.

As stated previously, APHIS' policy is to regulate hosts of quarantine pests at the genus level. This is because many pests or pathogens are not specific to one particular species within a taxon. When a new host species is identified as a host, additional scientific studies will often identify other host species within that genus. Therefore, regulating all species within the genus is the preferred course of action until a PRA is conducted. Only countries where significant trade with the United States in Vaccinium spp. has been established will be exempt from NAPPRA listing.

One commenter asked for clarification of a statement made in the datasheet for Moniliophthora perniciosa that “geographical variations within the pathogen impact resistance.” The commenter asked whether this means there are geographical variations in the virulence of the pathogen.

Evidence does seem to suggest that the pathogen may be more virulent in some regions than in others. A PRA conducted for a host taxon from a country where M. perniciosa is present would provide more information regarding virulence as well as any possible mitigations related to that information.

One commenter stated that Monochamus alternatus is also present in Korea, Vietnam, Laos, Taiwan, and Hong Kong and asked why host taxa from those countries, specifically Acer and Cryptomeria, were not included on the NAPPRA list.

Acer is already listed on the NAPPRA list for all countries except Canada, the Netherlands, and New Zealand, and Cryptomeria is already listed on the NAPPRA list for all countries except Canada. These additions were made in the April 2013 NAPPRA notice.

Phytophthora kernoviae. One commenter asked that exemption from NAPPRA listing be considered for tissue culture when testing is conducted that shows freedom from specific pests. The commenter cited a study suggesting that it is possible to test tissue cultures for the presence of P. kernoviae.

While properly tissue-cultured plants are pest-free, plants that are infected with disease prior to tissue culture are likely to be infected when the plant comes out of tissue culture as well. Plants that are added to the NAPPRA list may be hosts of quarantine plant pests for which tissue culturing is not an adequate mitigation, or for which there may be special requirements for tissue culturing. In order to fully consider whether tissue culture is an adequate mitigation for all the pests associated with a taxon of plants for planting, we would need to conduct a PRA. Therefore, we cannot exempt the importation of tissue cultures of plant taxa listed as NAPPRA.

One commenter stated that restricting the importation of host plant taxa based on the occurrence of P. kernoviae in only one location in England does not warrant restrictions on the importation of host taxa from all countries.

As mentioned in the datasheet made available with the May 6, 2013, NAPPRA notice, P. kernoviae has been found in Ireland and New Zealand as well as in England. This may be evidence of the spread of the pest through the global movement of plants. This, coupled with the number of confirmed hosts and the lack of specific control measures available for the disease, led us to add host taxa from all countries without significant trade in those host taxa to the NAPPRA list. When requested, a PRA will help determine the risk of this pest on host material from a country without a history of significant trade.

Two commenters stated that host taxa of ALB and CLB should be exempted from NAPPRA listing when host plants and cuttings are less than 10 mm in diameter, a size that is not susceptible to ALB and CLB infestation. One commenter stated that this exemption should also apply to host plants and cuttings when imported from countries where ALB and CLB are not present.

We have used the biology of the pest to institute sufficient phytosanitary measures to mitigate the risk for taxa that are being traded in significant amounts from countries where we have import history to determine the presence of other quarantine pests. We are not, however, exempting any plant material less than 10mm in diameter from an ALB or CLB host taxon from the NAPPRA category, as NAPPRA listing does not address mitigation measures for pests. In order to authorize the importation of plant material from a new source, we would need to conduct a PRA to analyze all the relevant risks associated with their importation. A PRA is required to determine all quarantine pests that would follow that host pathway and to determine appropriate phytosanitary measures, including size exemptions, for all pests of concern.

Therefore, in accordance with the regulations in § 319.37-2a(b)(2), we are adding 22 taxa of plants for planting that are quarantine pests and 34 taxa of plants for planting that are hosts of 8 quarantine pests to the list of taxa whose importation is NAPPRA. These taxa include all taxa listed in the May 2013 notice except for Callistephus, Chrysanthemum, and Eustoma spp., which we are removing from the NAPPRA list. A complete list of taxa added to the NAPPRA list and the restrictions placed on their importation can be found at the address in footnote 1 of this document or on the PPQ Web site at http://www.aphis.usda.gov/import_export/plants/plant_imports/Q37/nappra/index.shtml. We are also exempting Hibiscus spp. from Denmark and Annona, Camellia, Cercidiphyllum, and Pennisetum spp. from Canada from NAPPRA listing.

Title: Johne's Disease in Domestic Animals.

OMB Control Number: 0579-0338.

Type of Request: Revision to and extension of approval of an information collection.

Abstract: Under the authority of the Animal Health Protection Act (7 U.S.C. 8301 et seq.), the Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture is authorized, among other things, to prohibit or restrict the importation and interstate movement of animals and animal products to prevent the introduction into and dissemination within the United States of livestock diseases and pests.

Disease prevention is the most effective method for maintaining a healthy animal population and for enhancing APHIS' ability to compete in the world market of animal and animal product trade. Johne's disease affects cattle, sheep, goats, and other ruminants. It is an incurable and contagious disease that results in progressive wasting and eventual death. The disease is nearly always introduced into a healthy herd by an infected animal that is not showing symptoms of the disease.

The regulations in 9 CFR part 80 pertain specifically to the interstate movement of domestic animals that are positive to an official test for Johne's disease. These regulations provide that cattle, sheep, goats, and other domestic animals that are positive to an official test for Johne's disease may generally be moved interstate only to a recognized slaughtering establishment or to an approved livestock facility for sale to such an establishment. However, they may also be moved for purposes other than slaughter under certain conditions. Moving Johne's-positive livestock interstate for slaughter or for other purposes without increasing the risk of disease spread requires a movement permit or an owner-shipper statement, official ear tags, and a permission to move request. Permission may also be sought, in writing, for movement of animals that do not have a permit, owner-shipper statement, or ear tags.

To more accurately reflect the current activities, APHIS has revised the title of this information collection from “Voluntary Bovine Johne's Disease Control Program” to “Johne's Disease in Domestic Animals.”

We are asking the Office of Management and Budget (OMB) to approve our use of these information collection activities, as described, for an additional 3 years.

The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:

(1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;

(2) Evaluate the accuracy of our estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;

(3) Enhance the quality, utility, and clarity of the information to be collected; and

(4) Minimize the burden of the collection of information on those who are to respond, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies; e.g., permitting electronic submission of responses.

Estimate of burden: The public reporting burden for this collection of information is estimated to average 0.69 hours per response.

Respondents: Accredited veterinarians, herd owners, and livestock shippers.

Estimated annual number of respondents: 7.

Estimated annual number of responses per respondent: 2.

Estimated annual number of responses: 13.

Estimated total annual burden on respondents: 9 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)

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

Title: National Animal Health Monitoring System; Equine Herpesvirus Study.

OMB Control Number: 0579-0399.

Type of Request: Reinstatement of an approved information collection.

Abstract: Under the Animal Health Protection Act (7 U.S.C. 8301 et seq.), the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA) is authorized, among other things, to protect the health of U.S. livestock and poultry populations by preventing the introduction and interstate spread of serious diseases and pests of livestock and for eradicating such diseases from the United States when feasible. In connection with this mission, APHIS operates the National Animal Health Monitoring System (NAHMS), which collects nationally representative, statistically valid, and scientifically sound data on the prevalence and economic importance of livestock diseases and associated risk factors.

NAHMS' epidemiologic investigations are a collaborative industry and government initiative to help determine the most effective means of preventing and controlling livestock disease outbreaks. APHIS is the only agency responsible for collecting data on livestock health. Participation in any NAHMS study is voluntary, and all data are confidential.

APHIS conducts an equine herpesvirus myeloencephalopathy (EHM) study as part of an ongoing series of NAHMS studies on the U.S. livestock population. The purpose of this study is to collect information using questionnaires to identify risk factors for EHM, the neurologic form of equine herpesvirus (EHV-1) in horses. EHV-1 is an infection of horses that can cause respiratory disease, abortion in mares, neonatal foal death, and/or neurologic disease. The virus can spread through direct horse-to-horse contact, through the air in equine environments, and on contaminated equipment, clothing, and hands. EHM is endemic to the United States and outbreaks are usually handled by the States affected; USDA becomes involved in cases involving multiple States or interstate movement of horses.

In person or by telephone interview, APHIS-designated data collectors will administer questionnaires to horse owners and trainers of horses infected with EHV-1 during outbreaks that include cases of EHM and horses that are noninfected to serve as case controls. The information collected is used to understand the risk factors for EHM, make recommendations for disease control, and provide guidance on the best ways to avoid future outbreaks based on a thorough analysis of the data.

We are asking the Office of Management and Budget (OMB) to approve our use of these information collection activities for 3 years.

The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:

(1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;

(2) Evaluate the accuracy of our estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;

(3) Enhance the quality, utility, and clarity of the information to be collected; and

(4) Minimize the burden of the collection of information on those who are to respond, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies; e.g., permitting electronic submission of responses.

Estimate of burden: The public reporting burden for this collection of information is estimated to average 0.79 hours per response.

Respondents: Horse owners and horse trainers.

Estimated annual number of respondents: 626.

Estimated annual number of responses per respondent: 1.57.

Estimated annual number of responses: 982.

Estimated total annual burden on respondents: 778 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)

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

Title: CCC Export Credit Guarantee (GSM-102) Program.

OMB Number: 0551-0004.

Expiration Date of Approval: November 30, 2017.

Type of Request: Revision of a currently approved information collection.

Abstract: The primary objective of the GSM-102 program is to expand U.S. agricultural exports by making available export credit guarantees to encourage U.S. private sector financing of foreign purchases of U.S. agricultural commodities on credit terms. The CCC currently has programs operating in at least 144 countries and regions with 167 exporters eligible to participate. Under 7 CFR part 1493, exporters, foreign banks, and U.S. banks are required to submit the following: (1) Information about the exporter, foreign banks, and U.S. banks for program participation; (2) applications for payment guarantees; (3) notices of assignment; (4) repurchase agreements; (5) information regarding the actual export of the commodity (evidence of export report); (6) notice of default and claims for loss; and (7) appeals. In addition, each exporter and exporter's assignee (U.S. financial institution) must maintain records on all information submitted to CCC and in connection with sales made under the GSM-102 program. The information collected is used by CCC to manage, plan, evaluate, and account for government resources. The reports and records are required to ensure the proper and judicious use of public funds.

Estimate of Burden: The public reporting burden for these collections is estimated to average 0.38 hours per response.

Respondents: U.S. exporters, U.S. financial institutions, and foreign financial institutions.

Estimated Number of Respondents: 88 per annum.

Estimated Number of Responses per Respondent: 42.05 per annum.

Estimated Total Annual Burden of Respondents: 1,423 hours.

Request for Comments: Send comments regarding (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information including validity of the methodology and assumption used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Copies of this information collection can be obtained from Connie Ehrhart, the Agency Information Collection Coordinator, at (202) 690-1690 or email at [email protected].

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

Article 5 of the WTO Agreement on Agriculture provides that additional import duties may be imposed on imports of products subject to tariffication as a result of the Uruguay Round, if certain conditions are met. The agreement permits additional duties to be charged if the price of an individual shipment of imported products falls below the average price for similar goods imported during the years 1986-88 by a specified percentage. It also permits additional duties to be imposed if the volume of imports of an article exceeds the average of the most recent 3 years for which data are available by 5, 10, or 25 percent, depending on the article. These additional duties may not be imposed on quantities for which minimum or current access commitments were made during the Uruguay Round negotiations, and only one type of safeguard, price or quantity, may be applied at any given time to an article.

Section 405 of the Uruguay Round Agreements Act requires that the President cause to be published in the Federal Register information regarding the price and quantity safeguards, including the quantity trigger levels, which must be updated annually based upon import levels during the most recent 3 years. The President delegated this duty to the Secretary of Agriculture in Presidential Proclamation No. 6763, dated December 23, 1994, 60 FR 1005 (Jan. 4, 1995). The Secretary of Agriculture further delegated this duty, which lies with the Administrator of the Foreign Agricultural Service (7 CFR 2.43(a)(2)). The Annex to this notice contains the updated quantity trigger levels.

Additional information on the products subject to safeguards and the additional duties which may apply can be found in subchapter IV of Chapter 99 of the Harmonized Tariff Schedule of the United States (2017) and in the Secretary of Agriculture's Notice of Uruguay Round Agricultural Safeguard Trigger Levels, published in the Federal Register at 60 FR 427 (Jan. 4, 1995).

Notice: As provided in Section 405 of the Uruguay Round Agreements Act, consistent with Article 5 of the WTO Agreement on Agriculture, the safeguard quantity trigger levels previously notified are superseded by the levels indicated in the Annex to this notice. The definitions of these products were provided in the Notice of Safeguard Action published in the Federal Register, at 60 FR 427 (Jan. 4, 1995).

Background

On May 9, 2017 (82 FR 21509), the Bureau of Industry and Security (BIS) published the Notice of Request for Public Comments and Public Hearing on Section 232 National Security Investigation of Imports of Aluminum. The May 9 notice specified that on April 26, 2017, the Secretary of Commerce (“Secretary”) initiated an investigation under section 232 of the Trade Expansion Act of 1962, as amended (19 U.S.C. 1862), to determine the effects on the national security of imports of aluminum. (See the May 9 notice for additional details on the investigation and the request for public comments.)

The May 9 notice also announced that the Department of Commerce will hold a public hearing on the investigation. The hearing will be held on June 22, 2017 at the U.S. Department of Commerce auditorium, 1401 Constitution Avenue NW., Washington, DC 20230. The hearing will begin at 10:00 a.m. local time and conclude at 1:00 p.m. local time. The hearing will assist the Department in determining whether imports of aluminum threaten to impair the national security and in recommending remedies, if such a threat is found to exist.

The May 9 notice included the following information: (a) Procedures for requesting participation in the hearing, including procedures for submitting comments; (b) conduct of the hearing; and (c) special accommodations for the hearing. (See the May 9 notice for additional details on these aspects of the public hearing.)

In addition to the May 9 notice, on June 2, 2017 (82 FR 25597), BIS published the notice, Change in Comment Deadline for Section 232 National Security Investigation of Imports of Aluminum. The June 2 notice moved the original deadline included in the May 9 notice for all written submissions up by six calendar days. Commenters now are encouraged to submit their comments by June 20, 2017, but all written submissions must be received by no later than June 23, 2017 to be considered in the drafting of the final report. (See the June 2 notice for additional details on the change in comment deadline.)

Today's notice provides additional details on the procedures for attending the hearing and for viewing the hearing, via webcast.

Registration: Individuals and entities who wish to attend the public hearing in person are required to pre-register for the hearing on-line at www.bis.doc.gov/232AluminumHearing. Anyone wishing to attend this public hearing must register by 5:00 p.m. (EST), Tuesday, June 20, 2017.

Webcast: The public hearing will be available live via webcast. Registration is not required to view the hearing via webcast. No log-in information is required. Please visit: www.bis.doc.gov/232AluminumHearing to be directed to the live webcast.

Visitor Access Requirement: For participants attending in person, please note that federal agencies can only accept a state-issued driver's license or identification card for access to federal facilities if such license or identification card is issued by a state that is compliant with the REAL ID Act of 2005 (Pub. L. 109-13), or by a state that has an extension for REAL ID compliance. The main entrance of the Department of Commerce is on 14th Street NW., between Pennsylvania Avenue and Constitution Avenue, across from the Ronald Reagan Building. Upon entering the building, please go through security and check in at the guard's desk. BIS staff will meet and escort visitors to the auditorium. Admittance to the auditorium for the hearing will be available beginning at 9:00 a.m. (EST) on June 22, 2017 and the hearing will start promptly at 10:00 a.m. (EST).

Non U.S. Citizens Please Note: All foreign national visitors who do not have permanent resident status must register to attend the hearing at www.bis.doc.gov/232aluminumhearing and must fax a copy of their passport to (202) 482-5361 by 5:00 p.m. (EST), Tuesday, June 20, 2017. Please also bring a copy of your passport on the day of the hearing to serve as identification. Failure to provide this information prior to arrival will result, at a minimum, in significant delays in entering the facility. Authority to gather this information is derived from United States Department of Commerce Department Administrative Order (DAO) number 207-12. Please visit www.bis.doc.gov/232AluminumHearing to register and for more details regarding this requirement.

The regulations governing the Department's scope determinations are found at 19 CFR 351.225. In past scope determinations,1 in accordance with 19 CFR 351.225(k)(1), the Department has relied on the scope language, along with descriptions of the merchandise contained in the petitions, the initial investigations, prior scope determinations, and rulings by the International Trade Commission (ITC) to determine that two-layer wood flooring products are outside the scope of the Orders. 2

On April 19, 2017, the Department published the Proposed Scope Clarification 3 to provide notice that the Department intends to clarify the scope of the Orders due to the large number of scope ruling requests concerning wood flooring products consisting of only two layers. Interested parties were invited to comment on the intended clarification.

The Department received two comment submissions from two groups of interested parties during the comment period.4 The first group agrees that the Department has received a large number of scope ruling requests concerning two-layer wood flooring products, and notes that the requests are being filed not because the order language is ambiguous, but, rather, because of concern that U.S. Customs and Border Protection (CBP) officials may not always distinguish between two-ply and subject merchandise.5 This group, therefore, does not believe that the Proposed Scope Clarification will necessarily eliminate the number of scope ruling requests received by the Department, and proposes, as an alternative, that the Department work more closely with CBP to ensure CBP knows the difference between subject and non-subject merchandise.6 Nonetheless, to the extent the clarification language is merely meant to reiterate the scope rulings that have already been issued, and is not intended to change the scope of the Orders, this group does not object.7

The second group agrees with the Proposed Scope Clarification and deems the language necessary to reflect more definitively that two-layer wood flooring products are excluded from the scope of the Orders, as it will expedite handling of entries by CBP and eliminate the need for further scope rulings.8 This group also proposes that the Department insert additional clarifying language to the exclusion section of the existing written scope description in order to emphasize the exclusion of two-layer wood flooring products from the scope of the Orders as follows: “Also excluded is wood flooring composed of two layers. Two layered flooring typically consists of a single wood veneer, or ply, in combination with a base layer of various constructions and materials, which may include wood.” 9

No other parties, including the petitioner, commented on the Proposed Scope Clarification.

The Proposed Scope Clarification is meant to clarify the Department's interpretation of the scope of the Orders, as provided in numerous past scope determinations, that the wood flooring products covered by the Orders are composed of a minimum of three layers. This clarification is not intended to change the scope of wood flooring products covered by the Orders, but is merely meant to clarify and inform the public and CBP that the Department has consistently interpreted the scope of the Orders to cover wood flooring products composed of a minimum of three layers. Further, this clarification will expedite CBP's processing of entries of both subject and non-subject wood flooring products, and reduce the need for further scope rulings with respect to two-layer wood flooring products.

However, in light of the comments received, and to further reiterate that the clarification is not intended to change the scope of wood flooring products covered by the Orders, but is merely meant to clarify the Department's interpretation, for purposes of this final scope clarification we are including an interpretive note as a footnote to the scope language, rather than add clarifying language to the scope itself. See Scope of the Orders section below at note 11. We are adopting this clarification for all segments of the proceeding under the Orders for which a determination is made on or after the effective date of this notice. We intend to notify CBP of this final scope clarification.

Lastly, although certain parties propose changing the existing scope by adding language specifically excluding two-layered flooring, we have not adopted this change. We find that the changes adopted herein are sufficient to accomplish the goals of the clarification, and that further language regarding a specific exclusion for two-layered flooring is not necessary.

Multilayered wood flooring is composed of an assembly of two or more layers or plies of wood veneer(s) 10 in combination with a core.11 The several layers, along with the core, are glued or otherwise bonded together to form a final assembled product. Multilayered wood flooring is often referred to by other terms, e.g., “engineered wood flooring” or “plywood flooring.” Regardless of the particular terminology, all products that meet the description set forth herein are intended for inclusion within the definition of subject merchandise.

All multilayered wood flooring is included within the definition of subject merchandise, without regard to: Dimension (overall thickness, thickness of face ply, thickness of back ply, thickness of core, and thickness of inner plies; width; and length); wood species used for the face, back and inner veneers; core composition; and face grade. Multilayered wood flooring included within the definition of subject merchandise may be unfinished (i.e., without a finally finished surface to protect the face veneer from wear and tear) or “prefinished” (i.e., a coating applied to the face veneer, including, but not exclusively, oil or oil-modified or water-based polyurethanes, ultra-violet light cured polyurethanes, wax, epoxy-ester finishes, moisture-cured urethanes and acid-curing formaldehyde finishes). The veneers may be also soaked in an acrylic-impregnated finish. All multilayered wood flooring is included within the definition of subject merchandise regardless of whether the face (or back) of the product is smooth, wire brushed, distressed by any method or multiple methods, or hand-scraped. In addition, all multilayered wood flooring is included within the definition of subject merchandise regardless of whether or not it is manufactured with any interlocking or connecting mechanism (for example, tongue-and-groove construction or locking joints). All multilayered wood flooring is included within the definition of the subject merchandise regardless of whether the product meets a particular industry or similar standard.

The core of multilayered wood flooring may be composed of a range of materials, including but not limited to hardwood or softwood veneer, particleboard, medium-density fiberboard, high-density fiberboard (“HDF”), stone and/or plastic composite, or strips of lumber placed edge-to-edge.

Multilayered wood flooring products generally, but not exclusively, may be in the form of a strip, plank, or other geometrical patterns (e.g., circular, hexagonal). All multilayered wood flooring products are included within this definition regardless of the actual or nominal dimensions or form of the product. Specifically excluded from the scope are cork flooring and bamboo flooring, regardless of whether any of the sub-surface layers of either flooring are made from wood. Also excluded is laminate flooring. Laminate flooring consists of a top wear layer sheet not made of wood, a decorative paper layer, a core-layer of HDF, and a stabilizing bottom layer.

Imports of the subject merchandise are provided for under the following subheadings of the Harmonized Tariff Schedule of the United States (“HTSUS”): 4412.31.0520; 4412.31.0540; 4412.31.0560; 4412.31.0620; 4412.31.0640; 4412.31.0660; 4412.31.2510; 4412.31.2520; 4412.31.2610; 4412.31.2620; 4412.31.3175; 4412.31.4040; 4412.31.4050; 4412.31.4060; 4412.31.4070; 4412.31.4075; 4412.31.4080; 4412.31.4140; 4412.31.4160; 4412.31.4175; 4412.31.5125; 4412.31.5135; 4412.31.5155; 4412.31.5165; 4412.31.5175; 4412.31.5225; 4412.31.6000; 4412.31.9100; 4412.32.0520; 4412.32.0540; 4412.32.0560; 4412.32.0565; 4412.32.0570; 4412.32.0640; 4412.32.0665; 4412.32.2510; 4412.32.2520; 4412.32.2525; 4412.32.2530; 4412.32.2610; 4412.32.2625; 4412.32.3125; 4412.32.3135; 4412.32.3155; 4412.32.3165; 4412.32.3175; 4412.32.3185; 4412.32.3225; 4412.32.5600; 4412.32.5700; 4412.39.1000; 4412.39.3000; 4412.39.4011; 4412.39.4012; 4412.39.4019; 4412.39.4031; 4412.39.4032; 4412.39.4039; 4412.39.4051; 4412.39.4052; 4412.39.4059; 4412.39.4061; 4412.39.4062; 4412.39.4069; 4412.39.5010; 4412.39.5030; 4412.39.5050; 4412.94.1030; 4412.94.1050; 4412.94.3105; 4412.94.3111; 4412.94.3121; 4412.94.3131; 4412.94.3141; 4412.94.3160; 4412.94.3171; 4412.94.4100; 4412.94.5100; 4412.94.6000; 4412.94.7000; 4412.94.8000; 4412.94.9000; 4412.94.9500; 4412.99.0600; 4412.99.1020; 4412.99.1030; 4412.99.1040; 4412.99.3110; 4412.99.3120; 4412.99.3130; 4412.99.3140; 4412.99.3150; 4412.99.3160; 4412.99.3170; 4412.99.4100; 4412.99.5100; 4412.99.5105; 4412.99.5115; 4412.99.5710; 4412.99.6000; 4412.99.7000; 4412.99.8000; 4412.99.9000; 4412.99.9500; 4418.71.2000; 4418.71.9000; 4418.72.2000; 4418.72.9500; 4418.74.2000; 4418.74.9000; 4418.75.4000; 4418.75.7000; 4418.79.0100; and 9801.00.2500.

While HTSUS subheadings are provided for convenience and customs purposes, the written description of the subject merchandise is dispositive.

BCP's base charge and rates for electric service are calculated annually based on formulas that are set for a five-year period. Since BCP begins a new 50-year marketing period in FY 2018, WAPA is proposing to update the rate-setting formulas effective October 1, 2017 through September 30, 2022. Proposed Rate Schedule BCP-F10 will update the existing forecast capacity rate formula to reflect BCP's current generating capacity of 2,074 megawatts. No other changes to the existing rate-setting formulas are proposed.

The proposed FY 2018 base charge and rates for BCP electric service are designed to recover an annual revenue requirement that includes operation and maintenance and replacements costs, interest expense, investment repayments, payments to states, and visitor services expenses. The total costs are offset by the projected revenue from water sales, visitor services, ancillary services, and late fees. The annual revenue requirement is the base charge for electric service divided equally between capacity and energy. The annual composite rate is the base charge divided by annual energy sales.

The proposed Rate Schedule BCP-F10 requires updated financial and hydrology data to calculate the annual base charge and rates. The proposed base charge for FY 2018 is $85,094,786 and the proposed composite rate is 24.39 mills/kilowatt-hour. The following table compares the existing and proposed base charge and composite rate:

The proposed FY 2018 base charge includes a one-time $15 million working capital fund primarily for Reclamation, which is an increase of approximately 22 percent compared to the FY 2017 base charge. Under the BCP Electric Service Contracts and Amended and Restated Implementation Agreements, Reclamation worked collaboratively with BCP contractors to establish the $15 million working capital fund for the new marketing period, to be collected in the FY 2018 base charge. The FY 2019 base charge is expected to decrease by $15 million after the collection of working capital in FY 2018 (subject to Reclamation's annual working capital evaluation). The working capital fund accounts for nearly all of the increase to the base charge. Increases in annual operation and maintenance and replacement costs, and decreases in debt service, uprating credits, non-power revenue, and carryover revenue account for the remaining increase to the base charge.

The proposed FY 2018 composite rate represents an increase of approximately 24 percent compared to the FY 2017 composite rate. The increase in the proposed base charge accounts for the composite rate increase.

This proposal, to be effective October 1, 2017, is preliminary and is subject to change upon publication of the final base charge and rates.

In establishing rate-setting formulas for electric service and the base charge and rates for BCP, WAPA will follow the formal public process set forth in 10 CFR parts 903 and 904, and review all comments it receives on the proposed base charge and rates before taking action.

WAPA is proposing this action under the Department of Energy (DOE) Organization Act (42 U.S.C. 7101-7352); the Reclamation Act of 1902 (ch. 1093, 32 Stat. 388), as amended and supplemented by subsequent enactments; and other acts that specifically apply to the project involved.

By Delegation Order No. 00-037.00B effective November 19, 2016, the Secretary of Energy delegated: (1) The authority to develop power and transmission rates to WAPA's Administrator; (2) the authority to confirm, approve, and place such rates into effect on an interim basis to the Deputy Secretary of Energy; and (3) the authority to confirm, approve, and place into effect on a final basis, to remand, or to disapprove such rates to the Federal Energy Regulatory Commission.

All brochures, studies, comments, letters, memorandums, or other documents WAPA initiates or uses to develop the proposed rate-setting formulas and the base charge and rates will be available for inspection and copying at the Desert Southwest Customer Service Regional Office, Western Area Power Administration, located at 615 South 43rd Avenue, Phoenix, Arizona 85009. Many of these documents and supporting information are available on WAPA's Web site at: http://www.wapa.gov/regions/DSW/Rates/Pages/boulder-canyon-rates.aspx.

In compliance with the National Environmental Policy Act (NEPA) of 1969, 42 U.S.C. 4321-4347; the Council on Environmental Quality Regulations for implementing NEPA (40 CFR parts 1500-1508); and DOE NEPA Implementing Procedures and Guidelines (10 CFR part 1021), WAPA is in the process of determining whether an environmental assessment or an environmental impact statement should be prepared or if this action can be categorically excluded from those requirements.

WAPA has an exemption from centralized regulatory review under Executive Order 12866; accordingly, no clearance of this notice by the Office of Management and Budget is required.

A. Background

On March 22, 2004, EPA issued a final rule amending the MSWLF criteria in 40 CFR 258 to allow for RD&D permits (69 FR 13242). This rule allows for variances from specified criteria for a limited period of time, to be implemented through state-issued RD&D permits. RD&D permits are available only in states with approved MSWLF permit programs that have been modified to incorporate RD&D permit authority. On May 10, 2016, the EPA issued a revision to the regulations allowing RD&D permits to increase the number of permit renewals allowed to six, for a total permit term of up to 21 years (40 CFR 258.4).

While states are not required to incorporate this new provision, those states interested in providing RD&D permits must seek approval from EPA before issuing such permits. On January 25, 2006 Illinois received a final notice of adequacy of its RD&D permit program (71 FR 4142). On March 21, 2017, IEPA submitted a notification to EPA Region 5 seeking Federal approval of its revised RD&D requirements per the procedures in 40 CFR 239.12. Illinois' revised RD&D provisions can be found in Part 813 of the Illinois Pollution Control Board's (IPCB), Title 35: Environmental Protection Regulations, in the January 19, 2017 opinion and order of the IPCB.

EPA has made a determination that the Illinois RD&D permit provisions as set out in Part 813 of the IPCB's, Title 35: Environmental Protection Regulations, in the January 19, 2017 opinion and order of the Illinois Pollution Control Board comply with the Federal criteria, as set forth in 40 CFR 258.4.

A. Background

On March 22, 2004, EPA issued a final rule amending the MSWLF criteria in 40 CFR 258 to allow for RD&D permits (69 FR 13242). This rule allows for variances from specified criteria for a limited period of time, to be implemented through state-issued RD&D permits. RD&D permits are available only in states with approved MSWLF permit programs that have been modified to incorporate RD&D permit authority. On May 10, 2016, the EPA issued a revision to the regulations allowing RD&D permits to increase the number of permit renewals allowed to six, for a total permit term of up to 21 years (40 CFR 258.4).

While states are not required to incorporate this new provision, those states interested in providing RD&D permits must seek approval from EPA before issuing such permits. On February 15, 2005, Minnesota received approval of its RD&D permit program (Minn. R. 7035.0450). On March 24, 2017, MPCA submitted a notification to EPA Region 5 seeking Federal approval of its RD&D requirements per the procedures in 40 CFR 239.12. Minnesota's rules authorizing RD&D permits (Minn. R. 7035.0450) do not establish a specific term in years and instead incorporate by reference 40 CFR 258.4. Therefore, Minn. R. 7035.0450 automatically updates with the additional permit renewal revision in 40 CFR 258.4.

EPA has made a determination that the Minnesota RD&D permit provisions as set out in Minn. R.7035.0450 comply with the Federal criteria, as set forth in 40 CFR 258.4.

A. Background

On March 22, 2004, EPA issued a final rule amending the MSWLF criteria in 40 CFR part 258 to allow for RD&D permits (69 FR 13242). This rule allows for variances from specified criteria for a limited period of time, to be implemented through state-issued RD&D permits. RD&D permits are available only in states with approved MSWLF permit programs that have been modified to incorporate RD&D permit authority. On May 10, 2016, the EPA issued a revision to the regulations allowing RD&D permits to increase the number of permit renewals allowed to six, for a total permit term of up to 21 years (40 CFR 258.4).

While states are not required to incorporate this new provision, those states interested in providing RD&D permits must seek approval from EPA before issuing such permits. On October 30, 2006, Michigan received approval of its RD&D permit program (71 FR 51614). On February 15, 2017, MDEQ submitted a notification to EPA Region 5 seeking Federal approval of its revised RD&D requirements per the procedures in 40 CFR 239.12. Michigan's revised RD&D provisions can be found in Part 115 of the Natural Resources and Environmental Protection Act as amended by 2016 PA 437.

EPA has made a determination that the Michigan RD&D permit provisions as set out in Part 115 of the Natural Resources and Environmental Protection Act as amended by 2016 PA 437 comply with the Federal criteria, as set forth in 40 CFR 258.4.

In accordance with regulations at 40 CFR part 53, the EPA evaluates various methods for monitoring the concentrations of those ambient air pollutants for which EPA has established National Ambient Air Quality Standards (NAAQSs) as set forth in 40 CFR part 50. Monitoring methods that are determined to meet specific requirements for adequacy are designated by the EPA as either reference or equivalent methods (as applicable), thereby permitting their use under 40 CFR part 58 by States and other agencies for determining compliance with the NAAQSs. A list of all reference or equivalent methods that have been previously designated by EPA may be found at http://www.epa.gov/ttn/amtic/criteria.html.

The EPA hereby announces the designation of one new reference method for measuring concentrations of CO in ambient air and one new equivalent method for measuring concentrations of NO2 in ambient air. These designations are made under the provisions of 40 CFR part 53, as amended on October 26, 2015 (80 FR 65291-65468).

The new reference method for CO is an automated method (analyzer) utilizing a measurement principle based on non-dispersive infrared (NDIR) analysis and is identified as follows:

RFCA-0317-244, “Kentek Mezus Model 310 Carbon Monoxide Analyzer” non-dispersive infrared (NDIR) analyzer operated in the measurement range of 0-50 ppm, with 0.5 µm, 47 mm diameter Teflon® filter installed, operated at any ambient temperatures between 20 °C and 30 °C, at nominal input line voltages of 110 VAC or 220 VAC and frequencies of 50 to 60 Hz, with temperature and pressure compensation, at a nominal sampling flow rate of 800 cc/min, and operated according to the Kentek Mezus 310 CO User's Instruction Manual.

This application for a reference method determination for this CO method was received by the Office of Research and Development on May 25, 2016. This analyzer is commercially available from the applicant, Kentek Environmental Technology, Hanshin S Meca Room #526, 65 Techbi 3-ro, Yuseong-gu, Daejeon, Republic of Korea, 34016.

The new equivalent method for NO2 is an automated method (analyzer) utilizing a measurement principle based on cavity attenuated phase shift (CAPS) spectroscopy and is identified as follows:

EQNA-0217-242, “Ecotech Serinus 60 NO2 CAPS (Cavity Attenuated Phase Shift) Analyzer” operated at temperatures between 20 °C and 45 °C, a line voltage between 80V and 260V, and with or without any of the following options: Rack mounts, internal pump, internal permeation device, high pressure calibration ports, Ethernet output. The following menu choices must be selected: Control Loop—Enabled; Diagnostic Mode—Operate; Pres/Temp/Flow Compensation—Enabled; Span Compensation—Disabled, and operated according to the Serinus 60 User Manual.

This application for an equivalent method determination for this NO2 method was received by the Office of Research and Development on January 11, 2017. This analyzer is commercially available from the applicant, Ecotech Pty. Ltd., 1492 Ferntree Gully Rd., Knoxfield, Victoria, 3180, Australia.

Representative test analyzers have been tested in accordance with the applicable test procedures specified in 40 CFR part 53, as amended on October 26, 2015. After reviewing the results of those tests and other information submitted by the applicant, EPA has determined, in accordance with part 53, that these methods should be designated as a reference or equivalent method.

As a designated reference or equivalent method, these methods are acceptable for use by states and other air monitoring agencies under the requirements of 40 CFR part 58, Ambient Air Quality Surveillance. For such purposes, each method must be used in strict accordance with the operation or instruction manual associated with the method and subject to any specifications and limitations (e.g., configuration or operational settings) specified in the designated method description (see the identification of the method above).

Use of the method also should be in general accordance with the guidance and recommendations of applicable sections of the “Quality Assurance Handbook for Air Pollution Measurement Systems, Volume I,” EPA/600/R-94/038a and “Quality Assurance Handbook for Air Pollution Measurement Systems, Volume II, Ambient Air Quality Monitoring Program,” EPA-454/B-13-003, (both available at http://www.epa.gov/ttn/amtic/qalist.html). Provisions concerning modification of such methods by users are specified under Section 2.8 (Modifications of Methods by Users) of Appendix C to 40 CFR part 58.

Consistent or repeated noncompliance with any of these conditions should be reported to: Director, Exposure Methods and Measurement Division (MD-E205-01), National Exposure Research Laboratory, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711.

Designation of these reference and equivalent methods is intended to assist the States in establishing and operating their air quality surveillance systems under 40 CFR part 58. Questions concerning the commercial availability or technical aspects of the method should be directed to the applicant.

Public Hearing. Persons wishing to request a public hearing may do so, in writing, by the expiration date of this public comment period. A public hearing is a formal meeting whereby EPA officials hear the public's views and concerns about an EPA action or proposal. A request for a public hearing must state the nature of the issues to be raised, reference the NPDES permit name and permit number, and include the requester's name, address, and telephone number.

Document Viewing Locations. The re-proposed General Permit and Fact Sheet may also be viewed at the following location: EPA Region 10 Library, Park Place Building, 1200 6th Avenue, Suite 900, Seattle, WA 98101; (206) 553-1289. EPA's current administrative record for the draft General Permit is available for review at the EPA Region 10 Office, Park Place Building, 1200 6th Avenue, Suite 900, Seattle, WA 98101, between 9:00 a.m. and 4:00 p.m., Monday through Friday. Contact Catherine Gockel at [email protected] or (206) 553-0325.

State Water Quality Standards and Certification. The General Permit's area of coverage is only in federal waters, thus EPA is not seeking 401 certification from any State or Tribe. However, seafood waste discharged under this General Permit could potentially affect waters of Washington and Oregon. EPA has sent the draft General Permit to the States of Oregon and Washington as required under Section 401(a)(2) and received feedback from each State.

Coastal Zone Management Act—Federal Consistency Determination. Section 307 of the Coastal Zone Management Act of 1972 (CZMA) requires that federal actions, within and outside the coastal zone, which have reasonably foreseeable effects on any coastal use (land or water) or natural resource of the coastal zone be consistent with the enforceable policies of a state's federally approved coastal management program. Federal agency activities must be consistent to the maximum extent practicable with the enforceable policies of a state coastal management program, and license and permit and financial assistance activities must be fully consistent. EPA has submitted CZMA federal consistency determinations to Washington and Oregon. The consistency determinations conclude that the General Permit is consistent with the enforceable policies of each State. Both States will now review the consistency determinations and General Permit, and will provide their own opportunities for public notice.

Endangered Species Act. Section 7 of the Endangered Species Act, 16 U.S.C. 1531-1544, requires federal agencies to consult with the National Marine Fisheries Service (NMFS) and the U.S. Fish and Wildlife Service (USFWS) if their actions have the potential to affect any threatened or endangered species. EPA analyzed the discharges proposed to be authorized by the draft General Permit and their potential to adversely affect any of the threatened or endangered species or their designated critical habitat areas in the vicinity of the discharges in a Biological Evaluation dated August 2015. On December 18, 2015, NMFS concurred with EPA that the proposed action is not likely to adversely affect the ESA-listed fish, marine mammals, and turtles under NMFS jurisdiction. On September 29, 2015, EPA received a response from USFWS indicating that the draft General Permit has the potential to affect ESA-listed or migratory birds. EPA has updated its Biological Evaluation to reflect changes to the re-proposed General Permit. EPA has reviewed the re-proposed draft permit and determined that the proposed changes would not alter the original conclusions that the discharges may affect, but are not likely to adversely affect listed, proposed, and candidate species or their designated critical habitat areas. The Fact Sheet, the re-proposed draft General Permit, and the revised Biological Evaluation will be sent to NMFS and USFWS for review during the public comment period.

Essential Fish Habitat. The Magnuson-Stevens Fishery Conservation and Management Act requires EPA to consult with NMFS when a proposed permit action has the potential to adversely affect Essential Fish Habitat (EFH). The EPA submitted a Biological Evaluation dated August 2015 to NMFS, which included an EFH assessment. The EFH assessment concluded that the discharges authorized by the draft General Permit will not adversely affect EFH. On December 18, 2015, the NMFS communicated to the EPA that the proposed action could adversely affect EFH because of impacts to water quality and to benthic conditions. The NMFS provided conservation recommendations to avoid, mitigate, or offset the impact of the proposed action on EFH. The EPA has considered these recommendations and responded via letter.

Executive Order 12866. The Office of Management and Budget exempts this action from the review requirements of Executive Order 12866 pursuant to Section 6 of that order.

Paperwork Reduction Act. EPA has reviewed the requirements imposed on regulated facilities in the draft General Permit and finds them consistent with the Paperwork Reduction Act of 1980, 44 U.S.C. 3501 et seq.

National Marine Sanctuaries Act. Section 304(d) of the NMSA (16 U.S.C § 1434(d)) requires federal agencies to consult with the Secretary of Commerce, through NOAA, regarding any federal action or proposed action, including activities authorized by federal license, lease, or permit, that is likely to destroy, cause the loss of, or injure any sanctuary resource. In a letter dated May 25, 2016, the Sanctuary provided the EPA with recommended alternatives to protect Sanctuary resources and minimize or mitigate injury to Sanctuary resources associated with the proposed General Permit. The EPA has considered the Sanctuary's recommendations and has responded via letter.

Regulatory Flexibility Act. Under the Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., a federal agency must prepare an initial regulatory flexibility analysis “for any proposed rule” for which the agency “is required by section 553 of the Administrative Procedure Act (APA), or any other law, to publish general notice of proposed rulemaking.” The RFA exempts from this requirement any rule that the issuing agency certifies “will not, if promulgated, have a significant economic impact on a substantial number of small entities.” EPA has concluded that NPDES General Permits are permits, not rulemakings, under the APA and thus not subject to APA rulemaking requirements or the RFA.

I. Background

EPA's light-duty vehicle greenhouse gas (GHG) program provides three pathways by which a manufacturer may accrue off-cycle carbon dioxide (CO2) credits for those technologies that achieve CO2 reductions in the real world but where those reductions are not adequately captured on the test used to determine compliance with the CO2 standards, and which are not otherwise reflected in the standards' stringency. The first pathway is a predetermined list of credit values for specific off-cycle technologies that may be used beginning in model year 2014.1 This pathway allows manufacturers to use conservative credit values established by EPA for a wide range of technologies, with minimal data submittal or testing requirements, as long as the technologies meet EPA regulatory definitions. In cases where the off-cycle technology is not on the menu but additional laboratory testing can demonstrate emission benefits, a second pathway allows manufacturers to use a broader array of emission tests (known as “5-cycle” testing because the methodology uses five different testing procedures) to demonstrate and justify off-cycle CO2 credits.2 The additional emission tests allow emission benefits to be demonstrated over some elements of real-world driving not adequately captured by the GHG compliance tests, including high speeds, hard accelerations, and cold temperatures. These first two methodologies were completely defined through notice and comment rulemaking and therefore no additional process is necessary for manufacturers to use these methods. The third and last pathway allows manufacturers to seek EPA approval to use an alternative methodology for determining the off-cycle CO2 credits.3 This option is only available if the benefit of the technology cannot be adequately demonstrated using the 5-cycle methodology. Manufacturers may also use this option for model years prior to 2014 to demonstrate off-cycle CO2 reductions for technologies that are on the predetermined list, or to demonstrate reductions that exceed those available via use of the predetermined list.

Under the regulations, a manufacturer seeking to demonstrate off-cycle credits with an alternative methodology (i.e., under the third pathway described previously) must describe a methodology that meets the following criteria:

• Use modeling, on-road testing, on-road data collection, or other approved analytical or engineering methods;

• Be robust, verifiable, and capable of demonstrating the real-world emissions benefit with strong statistical significance;

• Result in a demonstration of baseline and controlled emissions over a wide range of driving conditions and number of vehicles such that issues of data uncertainty are minimized;

• Result in data on a model type basis unless the manufacturer demonstrates that another basis is appropriate and adequate.

Further, the regulations specify the following requirements regarding an application for off-cycle CO2 credits:

• A manufacturer requesting off-cycle credits must develop a methodology for demonstrating and determining the benefit of the off-cycle technology, and carry out any necessary testing and analysis required to support that methodology.

• A manufacturer requesting off-cycle credits must conduct testing and/or prepare engineering analyses that demonstrate the in-use durability of the technology for the full useful life of the vehicle.

• The application must contain a detailed description of the off-cycle technology and how it functions to reduce CO2 emissions under conditions not represented on the compliance tests.

• The application must contain a list of the vehicle model(s) which will be equipped with the technology.

• The application must contain a detailed description of the test vehicles selected and an engineering analysis that supports the selection of those vehicles for testing.

• The application must contain all testing and/or simulation data required under the regulations, plus any other data the manufacturer has considered in the analysis.

Finally, the alternative methodology must be approved by EPA prior to the manufacturer using it to generate credits. As part of the review process defined by regulation, the alternative methodology submitted to EPA for consideration must be made available for public comment.4 EPA will consider public comments as part of its final decision to approve or deny the request for off-cycle credits.

Using the alternative methodology approach discussed previously, BMW, Ford, and Hyundai are applying for credits for an air conditioning compressor manufactured by Denso that results in air conditioning efficiency credits beyond those provided in the regulations. This compressor, known as the Denso SAS compressor, improves the internal valve system within the compressor to reduce the internal refrigerant flow necessary throughout the range of displacements that the compressor may use during its operating cycle. The addition of a variable crankcase suction valve allows a larger mass flow under maximum capacity and compressor start-up conditions (when high flow is ideal), and then it can reduce to smaller openings with reduced mass flow in mid- or low-capacity conditions. The refrigerant exiting the crankcase is thus optimized across the range of operating conditions, reducing the overall energy consumption of the air conditioning system.

The “5-cycle” methodology does not adequately measure the real-world greenhouse gas reduction benefits of this compressor because the only one of the five tests with the air conditioner operating is conducted under worst-case conditions (high temperature, high solar load, and high humidity), not the more moderate conditions where the technology provides the majority of its benefits.

In December 2014, General Motors (GM) requested off-cycle GHG credits for the use of the Denso SAS compressor. GM worked with Denso to perform bench testing of compressors with and without the improvements and quantified the impact, which supported an off-cycle credit of 1.1 grams/mile. GM substantiated these results by also performing vehicle tests using the AC17 procedure. After public notice and comment, EPA approved GM's request in September 2015.5

The credits calculated for the Denso SAS compressor would be in addition to the credits of 1.7 grams/mile for variable-displacement A/C compressors already allowed under EPA regulations.6 However, it is important to note that EPA regulations place a limit on the cumulative credits that can be claimed for improving the efficiency of A/C systems. The rationale for this limit is that the additional fuel consumption of A/C systems can never be reduced to zero, and the limits established by regulation reflect the maximum possible reduction in fuel consumption projected by EPA. These limits, or caps, on credits for A/C efficiency, must also be applied to A/C efficiency credits granted under the off-cycle credit approval process. In other words, cumulative A/C efficiency credits for an A/C system—from the A/C efficiency regulations and those granted via the off-cycle regulations—must comply with the stated limits.

BMW is requesting an off-cycle GHG credit of 1.1 grams CO2 per mile for the Denso SAS compressor (the same as was approved for GM in 2015). BMW repeated the bench test modeling analysis using vehicle-specific BMW input data, and, like the original Denso analysis, demonstrated a benefit of 1.1 grams/mile. Like GM, BMW also ran vehicle tests using the AC17 test. Six tests were conducted on a 3-series BMW, resulting in a calculated benefit of 1.2 grams/mile, thus substantiating the bench test results. Based on these results, BMW is requesting a credit of 1.1 grams/mile for all BMW vehicles equipped with the Denso SAS compressor with variable crankcase suction valve technology, starting with 2016 model year vehicles. Details of the testing and analysis can be found in the manufacturer's application.

Ford is requesting an off-cycle GHG credit of 1.1 grams CO2 per mile for the Denso SAS compressor (the same as was approved for GM in 2015). Ford cited the bench test modeling analysis referenced in the original GM application, which demonstrated a benefit of 1.1 grams/mile. Ford also ran vehicle tests using the AC17 test. Six tests were conducted on a 2017 Lincoln MKC, resulting in a calculated benefit of 1.5 grams/mile, thus substantiating the bench test results. Based on these results, Ford is requesting a credit of 1.1 grams/mile for all 2017 and later model year Ford vehicles equipped with the Denso SAS compressor with variable crankcase suction valve technology. Details of the testing and analysis can be found in the manufacturer's application.

Hyundai is requesting an off-cycle GHG credit of 1.4 grams CO2 per mile for the Denso SAS compressor. Hyundai repeated the bench test modeling analysis using vehicle-specific Hyundai input data, which demonstrated a benefit of 1.4 grams/mile. Like the other manufacturers, Hyundai also ran vehicle tests using the AC17 test. Two tests were conducted on a Hyundai Sonata, resulting in a calculated benefit of 9.3 grams/mile, substantially more than the bench test results. Based on these results, Hyundai is requesting a credit of 1.4 grams/mile for all 2015 through 2017 model year Hyundai Sonata models equipped with the Denso SAS compressor with variable crankcase suction valve technology. Details of the testing and analysis can be found in the manufacturer's application.

Ford is requesting GHG credits for alternators with improved efficiency relative to a baseline alternator. This request is for the 2009 and later model years. Automotive alternators convert mechanical energy from a combustion engine into electrical energy that can be used to power a vehicle's electrical systems. Alternators inherently place a load on the engine, which results in increased fuel consumption and CO2 emissions. High efficiency alternators use new technologies to reduce the overall load on the engine yet continue to meet the electrical demands of the vehicle systems, resulting in lower fuel consumption and lower CO2 emissions. Some comments on EPA's proposed rule for GHG standards for the 2016-2025 model years suggested that EPA provide a credit for high-efficiency alternators on the pre-defined list in the regulations. While EPA agreed that high-efficiency alternators can reduce electrical load and reduce fuel consumption, and that these impacts are not seen on the emission test procedures because accessories that use electricity are turned off, EPA noted the difficulty in defining a one-size-fits-all credit due to lack of data.7 Ford proposes a methodology that would scale credits based on the efficiency of the alternator; alternators with efficiency (as measured using an accepted industry standard procedure) above a baseline value could get credits from 0.2 to 1.9 grams/mile. Details of the testing and analysis can be found in the manufacturer's application.

Ford is requesting off-cycle credits for glass/glazing that reduces the amount of solar energy that is transmitted through the windows. By doing so, interior cabin temperatures can be reduced, which results in a reduction in the amount of energy needed to cool the cabin and maintain passenger comfort. Ford's request is fundamentally identical to the request submitted by Chrysler in 2013, which EPA subsequently approved in September of 2015.8

Ford's request is for 2010 and later model year vehicles, whereas the credits approved for Chrysler were limited to the model years before 2014 (after which EPA expects that credits would be gained via the regulatory “menu”, since the methodology essentially replicates EPA's methodology and produces similar credit values). Note that the regulations limit glass/glazing credits to 2.9 grams/mile for cars and 3.9 grams/mile for trucks, and that EPA will require that these caps be observed for all glass/glazing credits, regardless of the regulatory pathway by which those credits are claimed or granted. This is also true for the caps specified for the total credits from thermal control technologies (3.0 grams/mile for cars and 4.3 grams/mile for trucks). The technical and engineering reasons for these limits remain applicable and are not rendered moot because credits are granted through this public process.

Ford is requesting off-cycle credits for solar reflective paint. Like glass, by reducing the heat that is transmitted to the interior, interior cabin temperatures can be reduced, which results in a reduction in the amount of energy needed to cool the cabin and maintain passenger comfort. Ford's request is largely similar to the request submitted by Chrysler in 2013, which EPA subsequently approved in September of 2015.9 However, there is one significant difference. Chrysler noted two data points regarding the impact of reflective paint: A study by the National Renewable Energy Laboratory (NREL) that determined a cabin air breath temperature reduction of 1.2 degrees C, and a study by the Lawrence Berkeley National Laboratory for the California Energy Commission that showed a reduction of 5-6 degrees C. Chrysler's methodology, which EPA approved, used the more conservative value from the NREL study (as did EPA in our Technical Support Document to establish the menu values for reflective paint). Chrysler's methodology, which does not differ substantially from EPA's methodology outlined in our Technical Support Document, would produce credits of 0.4 grams/mile, comparable to the menu values for a paint with high reflectivity. Ford provided test data that indicated a cabin air breath temperature reduction closer to the California Energy Commission study, and the resulting credits would be up to about 2 grams/mile for the highest reflectivity paint, or five times the menu credit value documented in EPA's Technical Support Document. EPA is particularly interested in comments on Ford's data and methodology for these credits because of the different inputs used by Ford as well as the data those inputs are based on and the magnitude of the requested credits compared to the regulatory menu of credits for this technology.

Ford's request is for 2010 and later model year vehicles, whereas the credits approved for Chrysler were limited to the model years before 2014 (after which EPA expects that credits would be gained via the regulatory “menu”, since the methodology used by Chrysler essentially replicated EPA's methodology and produced similar credit values). Note that the regulations limit the cumulative credits from thermal control technologies to 3.0 grams/mile for cars and 4.3 grams/mile for trucks, and that EPA will require that these caps be observed for all thermal control credits, regardless of the regulatory pathway by which those credits are claimed or granted. The technical and engineering reasons for these limits remain applicable (a fact that is acknowledged by Ford in their application materials) and are not rendered moot because credits are granted through this public process instead of through the regulatory menu.

EPA has reviewed the applications for completeness and is now making the applications available for public review and comment as required by the regulations. The off-cycle credit applications submitted by BMW, Ford, and Hyundai (with confidential business information redacted) have been placed in the public docket (see ADDRESSES section in this preamble) and on EPA's Web site at the following locations:

EPA is providing a 30-day comment period on the applications for off-cycle credits described in this action, as specified by the regulations. The manufacturers may submit a written rebuttal of comments for EPA's consideration, or may revise an application in response to comments. After reviewing any public comments and any rebuttal of comments submitted by manufacturers, EPA will make a final decision regarding the credit requests. EPA will make its decision available to the public by placing a decision document (or multiple decision documents) in the docket and on EPA's Web site at the same manufacturer-specific pages shown previously. While the broad methodologies used by these manufacturers could potentially be used for other vehicles and by other manufacturers, the vehicle specific data needed to demonstrate the off-cycle emissions reductions would likely be different. In such cases, a new application would be required, including an opportunity for public comment.

Acronyms and Abbreviations. We use multiple acronyms and terms in this notice. While this list may not be exhaustive, to ease the reading of this notice and for reference purposes, the EPA defines the following terms and acronyms here:

Organization of This Document. The information in this notice is organized as follows:

In a Federal Register notice dated April 4, 2017, the EPA provided public notice and solicited comment on CP Chem's AMEL request under the CAA for the operation of an MPGF at an ethylene plant in Baytown, Texas, and for the operation of an MPGF at a polyethylene plant in Old Ocean, Texas (see 82 FR 16392).1 This action solicited comment on all aspects of the AMEL request, including the operating conditions specified in that action that are necessary to achieve a reduction in emissions of volatile organic compounds (VOC) and organic hazardous air pollutants (HAP) at least equivalent to the reduction in emissions required by various standards in 40 CFR parts 60, 61, and 63 that apply to emission sources that would be controlled by these MPGFs. These standards incorporate the design and operating requirements for flares in the General Provisions to parts 60 and 63 as part of the emission reduction requirements. Because the two proposed MPGFs cannot meet the velocity requirements in these General Provisions, CP Chem requested an AMEL. In its request, CP Chem demonstrates that the proposed AMEL for each of the two facilities would achieve at least equivalent emissions reductions as flares that meet the standards in the General Provisions.

This action provides a summary of the comments received as part of the public review process, our response to those comments, and our approval of the AMEL request received from CP Chem for use of MPGFs at both their ethylene plant in Baytown, Texas, and polyethylene plant in Old Ocean, Texas, along with the operating conditions they must follow for demonstrating compliance with the approved AMEL.

CP Chem submitted a complete MPGF AMEL request, following the MPGF AMEL framework that was published in the Federal Register (see 81 FR 23480, April 21, 2016), to the EPA on November 28, 2016. CP Chem sought an AMEL to operate an MPGF for use during limited HP maintenance, startup, and shutdown events, as well as during upset events at their ethylene plant in Baytown, Texas. In addition, CP Chem sought an AMEL to operate an MPGF during certain routine operations (i.e., the first two stages only), as well as during periods of maintenance, startup, shutdown, and upset at their polyethylene plant in Old Ocean, Texas. In its request, CP Chem cited various regulatory requirements in 40 CFR parts 60, 61, and 63 that will apply to the flare vent gas streams that will be collected and routed to their MPGFs at each of these two plants. See Table 1 for a list of regulations, by subparts, that CP Chem has identified as applicable to the two plants described above. These new source performance standards (NSPS) and national emissions standards for hazardous air pollutants (NESHAP) require that flares subject to these subparts meet the flare design and operating requirements in the General Provisions of part 60 and 63, respectively (i.e., 40 CFR 60.18(b) and 63.11(b)). CP Chem is requesting that the EPA approve the AMEL to be used by each of the two plants for complying with the flare requirements in the relevant subparts as specified in Table 1.

The provisions in each NSPS and NESHAP cited in Table 1 that ensure flares meet certain specific requirements when used to satisfy the requirements of the NSPS or NESHAP were established as work practice standards pursuant to CAA sections 111(h)(1) or 112(h)(1). For standards established according to these provisions, CAA sections 111(h)(3) and 112(h)(3) allow the EPA to permit the use of an AMEL by a source if, after notice and opportunity for comment,2 it is established to the Administrator's satisfaction that such AMEL will achieve emission reduction at least equivalent to the reduction required under the CAA section 111(h)(1) or 112(h)(1) standard. As noted in Table 1, many of the NSPS and NESHAP in the table above also include specific regulatory provisions allowing sources to request an AMEL.

CP Chem sought such an AMEL request because their MPGFs are not designed to operate below the maximum permitted velocity requirements for flares in the General Provisions of 40 CFR parts 60 and 63. CP Chem provided information that the MPGFs they propose to use will achieve a reduction in emissions at least equivalent to the reduction in emissions for flares complying with these General Provisions requirements (for further background information on the regulatory flare requirements and a facility's ability to request an AMEL, see 82 FR 16392-16399, April 4, 2017).

The EPA received eight public comments on this action. The public comments received fell into one of the following three bins: (1) General support for CP Chem's AMEL request, (2) general opposition to CP Chem's AMEL request, and (3) general comments outside the scope of the action. None of the comments raised issues or otherwise mentioned any specific aspect of the MPGFs (including any operating condition) proposed for either of the two plants or the EPA's authority to approve these AMEL under the CAA. None of the commenters who opposed the EPA's proposal to approve the AMEL with the operating conditions specified in the April 4, 2017, action asserted that the EPA lacked authority to approve the AMEL or that the AMEL would not achieve at least equivalent emissions reductions as flares that meet the standards in the General Provisions. Additionally, the one commenter who generally opposed CP Chem's AMEL request did not provide any substantive reason for why they opposed the request, other than to note that existing regulations should be followed. Therefore, no changes have been made to the operating conditions specified in the April 4, 2017, action.

Based on information the EPA received from CP Chem and the comments received through the public comment period, we are approving CP Chem's request for an AMEL and establishing operating requirements for the MPGF at CP Chem's ethylene plant in Baytown, Texas, and the MPGF at CP Chem's polyethylene plant in Old Ocean, Texas. The operating conditions for CP Chem's MPGF that will achieve a reduction in emissions at least equivalent to the reduction in emissions being controlled by a steam-assisted, air-assisted, or non-assisted flare complying with the requirements of either 40 CFR 63.11(b) or 40 CFR 60.18(b) are as follows: (1) The MPGF system for all HP stages at CP Chem's ethylene plant and for all HP stages excluding stage 1 and 2 for CP Chem's polyethylene plant must be designed and operated such that the net heating value of the combustion zone gas (NHV cz) is greater than or equal to 800 British thermal units per standard cubic foot (Btu/scf) or lower flammability limit of the combustion zone gas (LFL cz) is less than or equal to 6.5 percent by volume. The MPGF system for HP stages 1 and 2 of CP Chem's polyethlene plant must be designed and operated such that the NHV cz is greater than or equal to 600 Btu/scf or the LFL cz is less than or equal to 8.0 percent by volume. Owners or operators must demonstrate compliance with the NHV cz or LFL cz metric by continuously complying with a 15-minute block average. Owners or operators must calculate and monitor for the NHV cz or LFL cz according to the following:

(a) Calculation of NHV cz

(i) The owner or operator shall determine the net heating value of flare vent gas (NHV vg) by following the requirements of (1)(d)-(1)(e) below. If an owner or operator elects to use a monitoring system capable of continuously measuring (i.e., at least once every 15 minutes), calculating, and recording the individual component concentrations present in the flare vent gas, NHV vg shall be calculated using the following equation:

(ii) For all MPGF HP stages at CP Chem's ethylene plant and for all MPGF HP stages, excluding stage 1 and 2 for CP Chem's polyethylene plant, NHV vg = NHV cz.

(iii) For HP stages 1 and 2 of CP Chem's polyethlene plant MPGF, NHV cz shall be calculated using the following equation:

(b) Calculation of LFL cz

(i) The owner or operator shall determine LFL cz from compositional analysis data by using the following equation:

(ii) For all MPGF HP stages at CP Chem's ethylene plant and for all MPGF HP stages, excluding stages 1 and 2 for CP Chem's polyethylene plant, LFL vg = LFL cz.

(iii) For HP stages 1 and 2 of CP Chem's polyethlene plant MPGF, LFL cz shall be calculated using the following equation:

(c) The operator of an MPGF system shall install, operate, calibrate, and maintain a monitoring system capable of continuously measuring the volumetric flow rate of flare vent gas (Q vg) and the volumetric flow rate of total assist steam (Q s).

(i) The flow rate monitoring systems must be able to correct for the temperature and pressure of the system and output parameters in standard conditions (i.e., a temperature of 20 °C (68 °F) and a pressure of 1 atmosphere).

(ii) Mass flow monitors may be used for determining volumetric flow rate of flare vent gas provided the molecular weight of the flare vent gas is determined using compositional analysis so that the mass flow rate can be converted to volumetric flow at standard conditions using the following equation:

(iii) Mass flow monitors may be used for determining volumetric flow rate of total assist steam. Use Equation 5 to convert mass flow rates to volumetric flow rates. Use a molecular weight of 18 pounds per pound-mole for total assist steam.

(d) The operator shall install, operate, calibrate, and maintain a monitoring system capable of continuously measuring (i.e., at least once every 15 minutes), calculating, and recording the individual component concentrations present in the flare vent gas or the owner or operator shall install, operate, calibrate, and maintain a monitoring system capable of continuously measuring, calculating, and recording NHV vg (in Btu/scf).

(e) For each measurement produced by the monitoring system used to comply with (1)(d) above, the operator shall determine the 15-minute block average as the arithmetic average of all measurements made by the monitoring system within the 15-minute period.

(f) The operator must follow the calibration and maintenance procedures according to Table 3. Maintenance periods, instrument adjustments, or checks to maintain precision and accuracy and zero and span adjustments may not exceed 5 percent of the time the flare is receiving regulated material.

I. Background

Under section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264), the Secretary of Health and Human Services, has the authority to make and enforce regulations necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the United States and between U.S. states and territories. For purposes of carrying out and enforcing such regulations, the Secretary may authorize a variety of public health measures, including inspection, fumigation, disinfection, sanitation, pest extermination, destruction of animals or articles found to be sources of dangerous infection to human beings, and other measures. Since 1956, federal quarantine regulations have controlled the entry of dogs into the United States. See 21 FR 9870 (Dec. 12, 1956). Currently, HHS/CDC regulates the import of dogs into the United States under regulations found at 42 CFR 71.51. Among the principal concerns for regulating the import of dogs is to prevent the introduction and spread of rabies. Authority for carrying out 42 CFR 71.51 has been delegated to HHS/CDC's Division of Global Migration and Quarantine (DGMQ), which staffs and maintains quarantine stations at major U.S. ports of entry.

DGMQ oversees the import of dogs into the United States to ensure that dogs show no signs of communicable disease upon arrival and are vaccinated against rabies. Under 42 CFR 71.51, the owner or owner's agent must present a valid rabies vaccination certificate for a dog upon arrival at a U.S. port of entry. The only exceptions to this requirement are if the owner or agent submits satisfactory evidence that the dog, for the previous 6 months before arrival, has only been in a country that does not present a risk for canine rabies or the dog is to be taken to a research facility and vaccination would interfere with the purposes of the research.

Under 42 CFR 71.51(c)(2), however, the CDC Director may authorize admission of an inadequately immunized dog if the owner or owner's agent agrees to confine the dog under conditions that restrict its contact with humans and other animals until it is fully immunized against rabies. Under these circumstances, if the date of vaccination shown on the vaccination certificate is less than 30 days before the date of arrival and the dog was 3 months of age or older when vaccinated, the dog may be admitted into the United States, but must be confined until at least 30 days have elapsed since the date of vaccination. If the dog is unvaccinated upon arrival and is at least 3 months of age or older, it may be admitted, but must be confined until it is vaccinated against rabies and 30 days have elapsed since vaccination. If the dog is either unvaccinated or partially immunized upon arrival and is less than 3 months of age, it may be admitted, but must be confined until vaccinated against rabies at 3 months of age and for at least 30 days after the date of vaccination.

In 2014, HHS/CDC published guidance in the Federal Register clarifying that it allows an owner or agent to import an inadequately immunized dog into the United States only for purposes of personal pet ownership. See 79 FR 39403 (July 20, 2014). This document also described the criteria that HHS/CDC uses in determining whether to issue a dog confinement agreement that allows the entry into the United States and confinement of a dog until it is adequately immunized against rabies. The document further described the steps that an importer may take if an imported dog is denied entry into the United States, including the availability of a written appeal.

Through today's document, HHS/CDC is informing the public that it is changing its application process from a paper-based dog confinement agreement system to a web-based application and electronic permit system (Permit to Import a Dog Inadequately Immunized against Rabies). Effective August 18, 2017, an owner or owner's agent must apply for a Permit to Import a Dog Inadequately Immunized against Rabies at least 10 business days before arriving into the United States with an inadequately immunized dog through this web-based system. Permit applications to import an inadequately immunized dog will not be available at the port of entry and no permits will be issued at the port of entry. Inadequately immunized dogs arriving at a port of entry without an approved permit will be denied entry into the United States and re-exported to the country of origin at the owner's expense.

Effective, August 18, 2017, at least 10 business days before arriving into the United States with an inadequately immunized dog, an importer must apply online at https://www.cdc.gov/importation/ for a Permit to Import a Dog Inadequately Immunized against Rabies.

DGMQ will review a permit application within 3-5 business days of receiving the application and apply the criteria in Federal Register notice published at 79 FR 39403 (July 20, 2014). If the application is approved, a permit will be emailed to the dog's owner. The owner must present the permit to the Customs and Border Protection (CBP) officer at the first arriving port of entry into the United States. The permit will be collected by the CBP officer and sent to CDC.

If the permit application is denied, DGMQ will email the reasons for the denial to the dog's owner within 3-5 business days of receiving the application. The email will include instructions on whom to contact, including name, address, and telephone number, if the dog's owner has any questions, as well as information on how to submit an appeal. In accordance with current procedures, individuals who wish to contest CDC's determination will have five business days after receiving the denial to submit a written appeal. The individual must submit the appeal via email to [email protected], state the reasons for the appeal, and show that there is a genuine and substantial issue of fact in dispute. CDC will issue a response via email, which will constitute final agency action. The appeal will be reviewed and decided upon by a CDC senior management official who is senior to the employee who denied the initial permit application. In keeping with current practice, a successful appeal of a denial only permits the owner to import the dog into the United States at a later date under the requirements set forth in a dog import permit. The appeal does not entitle the owner to recover any costs related to returning a dog that has been denied entry to its country of origin and reimporting the dog into the United States. An owner or owner's agent will not be allowed to board a dog or arrange for its confinement at a port of entry pending a determination regarding the importer's application to import an inadequately immunized dog. Accordingly, inadequately immunized dogs arriving at a port of entry without an approved permit will be denied entry into the United States and re-exported to its country of origin at the owner's expense.

This change does not institute a new collection of information. The collection of information, has been previously approved by the Office of Management and Budget (OMB) in accordance with the requirements of the Paperwork Reduction Act (44 U.S.C. 3507) and assigned the following OMB control number: Foreign Quarantine: OMB Control No. 0920-0134, expiration date 5/31/2019.

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.

Evaluation of Medication-Assisted Treatment (MAT) for Opioid use disorder—New—National Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC).

CDC seeks a three-year OMB approval to collect evaluation information for Medication-Assisted Treatment (MAT) for Opioid use disorder.

About 2.4 million people aged 18 or older have opioid use disorders (OUDs) in the United States. At any given time, only half of these people receive some form of treatment, which may include medication-assisted treatment (MAT) or abstinence-based psychotherapy or self-help treatments (i.e., counseling without medication [COUN]). The rise in opioid overdose deaths, up from 2014-2015 due partly to a 72% rise in synthetic opioid overdose deaths alone, shows that engaging and retaining clients in OUD treatment is an urgent public health need. Only a few studies are available to help clients and providers make informed decisions about the risks and benefits associated with the different types of MATs. This information is crucial because even though each MAT drug helps prevent withdrawal symptoms and decreases cravings, differences in treatment approach and settings influence how people respond to the medication and, thus, their long-term treatment success.

The purpose of this evaluation is to conduct an epidemiologic, mixed-methods evaluation of OUD treatment in real-world outpatient settings. The study aims to have 3,000 participants from real-world outpatient settings to better understand the relationship between type of MAT and individual, provider, and contextual characteristics related to retention in treatment and abstinence from opioid use. The sites will be located across 10 diverse metropolitan statistical areas (MSAs) with four sites in each MSA. At each site, about 75 participants are expected to participate for a total of 300 per MSA. Across all MSAs, the study will aim to have 750 client participants in each of the four treatment conditions (MMT, BUP, NAL, and COUN).

The study will use a mixed-method approach using quantitative methods such as multilevel latent growth models, propensity score matching, latent class analysis and advance mediation analysis and qualitative methods such as interactive coding and analysis for common themes. The only cost to respondents will be time spent responding to the survey/screener.

ORR is continuously monitoring its capacity to shelter the UC referred to the Department of Health and Human Services (HHS), and the information received from interagency partners, to inform any future decisions or actions. The six recipients are:

ORR has been identifying additional capacity to provide shelter for potential increases in apprehensions of UC at the U.S. Southern Border. Planning for increased shelter capacity is a prudent step to ensure that ORR is able to meet its responsibility, by law, to provide shelter for Unaccompanied Children referred to its care by the Department of Homeland Security (DHS).

The expansion supplement grants will support the need to increase shelter capacity to accommodate the increasing numbers of UCs being referred by DHS. All grantees have the infrastructure, licensing, experience and appropriate level of trained staff to meet the service requirements and the urgent need for expansion of services. The grantees provide residential services to UC in the care and custody of ORR, as well as services to include counseling, case management, and additional support services to the family or to the UC and their sponsor when a UC is released from ORR's care and custody.

ORR has specific requirements for the provision of services. Award recipients must have the infrastructure, licensing, experience, and appropriate level of trained staff to meet those requirements. The expansion of the existing program and its services through this supplemental award is a key strategy for ORR to be prepared to meet its responsibility to provide shelter for UC referred to its care by DHS and so that the U.S. Border Patrol can continue its vital national security mission to prevent illegal migration and trafficking, and to protect the borders of the United States.

Statutory Authority: This program is authorized by—

(A) Section 462 of the Homeland Security Act of 2002, which in March 2003, transferred responsibility for the care and custody of Unaccompanied Alien Children from the Commissioner of the former Immigration and Naturalization Service to the Director of ORR of HHS.

(B) The Flores Settlement Agreement, Case No. CV85-4544-RJK (C. D. Cal. 1996), and the William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008 (Pub. L. 110-457), which authorizes post release services under certain conditions to eligible children. All programs must comply with the Flores Settlement Agreement, Case No. CV85-4544-RJK (C.D. Cal. 1996), pertinent regulations and ORR policies and procedures.

Section 2607(b)(1) of the Low Income Home Energy Assistance Act (the Act), (42 U.S.C. 8626(b)(1)) requires that, if the Secretary of HHS determines that, as of September 1 of any fiscal year, an amount in excess of 10 percent of the amount awarded to a grantee for that fiscal year (excluding Leveraging and REACH funds) will not be used by the grantee during that fiscal year, then the Secretary must notify the grantee and publish a notice in the Federal Register that such funds may be reallotted to LIHEAP grantees during the following fiscal year. If reallotted, the LIHEAP block grant allocation formula will be used to distribute the funds. No funds may be allotted to entities that are not direct LIHEAP grantees during FY 2017.

It has been determined that $3,253,866 in LIHEAP funds may be available for reallotment during FY 2017. This determination is based on FY 2016 Carryover and Reallotment Reports, which showed that 15 grantees reported reallotment funds (State of Arkansas, Association of Village Council Presidents, Cocopah Tribe of Arizona, Eastern Band of Cherokee Indians, State of Georgia, Hoh Indian Tribe, Kalispel Indian Community of the Kalispel Reservation, Oglala Sioux Tribe, Passamaquoddy Tribe at Pleasant Point, Poarch Band of Creeks, Quinault Indian Nation, Sault Ste. Marie Tribe of Chippewa Indians, The Chickasaw Nation, Three Affiliated Tribes of the Ft. Berthold Reservation, and the State of Vermont). Grantees submitted the FY 2016 Carryover and Reallotment Reports to OCS, as required by regulations applicable to LIHEAP at 45 CFR 96.81(b).

The LIHEAP statute allows grantees who have funds unobligated at the end of the federal fiscal year for which they are awarded to request that they be allowed to carry over up to 10 percent of their full-year allotments to the next federal fiscal year. Funds in excess of this amount must be returned to HHS and are subject to reallotment under section 2607(b)(1) of the Act (42 U.S.C. 8626(b)(1)). The amount described in this notice was reported by grantees as unobligated FY 2016 funds in excess of the amount that these grantees could carry over to FY 2017.

In accordance with section 2607(b)(3) of the Act (42 U.S.C. 8626(b)(3)), comments will be accepted for a period of 30 days from the date of publication of this notice.

After considering any comments submitted, all current LIHEAP grantees will be notified of the final reallotment amount redistributed to them for obligation in FY 2017. This decision will be published in an Information Memorandum that gets posted to ACF's Web site.

If funds are reallotted, they will be allocated in accordance with section 2604 of the Act (42 U.S.C. 8623) and must be treated by LIHEAP grantees receiving them as an amount appropriated for FY 2017. As FY 2017 funds, they will be subject to all requirements of the Act, including section 2607(b)(2) (42 U.S.C. 8626(b)(2)), which requires that a grantee obligate at least 90 percent of its total block grant allocation for a fiscal year by the end of the fiscal year for which the funds are appropriated, that is, by September 30, 2017.

Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Sections 525 through 528 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360aa through 360dd) give FDA statutory authority to do the following: (1) Provide recommendations on investigations required for approval of marketing applications for orphan drugs, (2) designate eligible drugs as orphan drugs, (3) set forth conditions under which a sponsor of an approved orphan drug obtains exclusive approval, and (4) encourage sponsors to make orphan drugs available for treatment on an “open protocol” basis before the drug has been approved for general marketing. The implementing regulations for these statutory requirements have been codified under part 316 (21 CFR part 316) and specify procedures that sponsors of orphan drugs use in availing themselves of the incentives provided for orphan drugs in the FD&C Act and sets forth procedures FDA will use in administering the FD&C Act with regard to orphan drugs.

Section 316.10 specifies the content and format of a request for written recommendations concerning the nonclinical laboratory studies and clinical investigations necessary for approval of marketing applications. Section 316.12 provides that, before providing such recommendations, FDA may require results of studies to be submitted for review. Section 316.14 contains provisions permitting FDA to refuse to provide written recommendations under certain circumstances. Within 90 days of any refusal, a sponsor may submit additional information specified by FDA. Based on past experience, FDA estimates that there will be one respondent to §§ 316.10, 316.12, and 316.14 requiring 50 hours of human resources annually.

Section 316.20 specifies the content and format of an orphan drug application which includes requirements that an applicant document that the disease is rare (affects fewer than 200,000 persons in the United States annually) or that the sponsor of the drug has no reasonable expectation of recovering costs of research and development of the drug. Section 316.21 specifies content of a request for orphan drug designation required for verification of orphan-drug status. Section 316.26 allows an applicant to amend the applications under certain circumstances. Based on past experience, FDA estimates 496 respondents to §§ 316.20, 316.21 and 316.26, requiring 93,000 hours of human resources annually.

The Common EMA/FDA Application Form for Orphan Medicinal Product Designation (Form FDA 3671) is intended to benefit sponsors who desire to seek orphan designation of drugs intended for rare diseases or conditions from both the European Commission and FDA by reducing the burden of preparing separate applications to meet the regulatory requirements in each jurisdiction. It highlights the regulatory cooperation between the United States and the European Union mandated by the Transatlantic Economic Council (TEC). Based on past experience, FDA estimates there will be 60 respondents using the form requiring 450 hours of human resources annually.

Section 316.22 specifies requirement of a permanent resident agent for foreign sponsors. Based on past experience, FDA estimates 70 respondents requiring 140 hours of human resources annually. Section 316.24(a) specifies a requirement that sponsors respond to deficiency letters from FDA on designation requests within 1 year of issuance of the deficiency letter, unless within that time frame, the sponsor requests an extension of time to respond. Based on past experience, FDA estimates 20 respondents requiring 40 hours of human resources annually.

Section 316.27 specifies content of a change in ownership of orphan-drug designation. Based on past experience, FDA estimates 63 respondents requiring 315 hours of human resources annually. Section 316.30 requires submission of annual reports, including progress reports on studies, a description of the investigational plan, and a discussion of changes that may affect orphan status. Based on number of orphan-drug designations, the number of respondents is estimated as 744 requiring 2,232 hours of human resources annually. Finally, § 316.36 describes information required of sponsor when there is insufficient quantity of approved orphan drug. Based on past experience, FDA estimates two respondents requiring 90 hours of human resources annually.

The information requested will provide the basis for an FDA determination that the drug is for a rare disease or condition and satisfies the requirements for obtaining orphan drug status. Secondly, the information will describe the medical and regulatory history of the drug. The respondents to this collection of information are biotechnology firms, drug companies, and academic clinical researchers.

FDA estimates the burden of this collection of information as follows:

FDA has experienced increases in: (1) The number of submissions to change ownership of orphan-drug designation (21 CFR 316.27), (2) the number of annual reports 21 CFR 316.30, and (3) assurances of the availability of sufficient quantities of the orphan drug and the holder's consent for the approval of other marketing applications for the same drug (21 CFR 316.36). In contrast, however, the use of Form FDA 3671, the application form to submit for product designation to the European Medicines Agency and to the FDA Office of Orphan Products, has decreased from 6,760 to 450 total burden hours.

Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

FDA regulations in part 11 (21 CFR part 11) provide criteria for acceptance of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records. Under these regulations, records and reports may be submitted electronically to FDA provided the Agency has stated its ability to electronically accept the records in an Agency-established public docket and that the other requirements of part 11 are met.

The recordkeeping provisions in part 11 (§§ 11.10, 11.30, 11.50, and 11.300) require the following standard operating procedures to assure appropriate use of, and precautions for, systems using electronic records and signatures: (1) § 11.10 specifies procedures and controls for persons who use closed systems to create, modify, maintain, or transmit electronic records; (2) § 11.30 specifies procedures and controls for persons who use open systems to create, modify, maintain, or transmit electronic records; (3) § 11.50 specifies procedures and controls for persons who use electronic signatures; and (4) § 11.300 specifies controls to ensure the security and integrity of electronic signatures based upon use of identification codes in combination with passwords. The reporting provision (§ 11.100) requires persons to certify in writing to FDA that they will regard electronic signatures used in their systems as the legally binding equivalent of traditional handwritten signatures.

The burden created by the information collection provision of this regulation is a one-time burden associated with the creation of standard operating procedures, validation, and certification. The Agency anticipates the use of electronic media will substantially reduce the paperwork burden associated with maintaining FDA required records. The respondents are businesses and other for-profit organizations, State or local governments, Federal Agencies, and nonprofit institutions.

FDA estimates the burden for the collection of information as follows:

Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Testing of messages in advance of a communication campaign provides an important role in improving FDA communications. The methods to be employed include individual indepth interviews, general public focus group interviews, intercept interviews, self-administered surveys, gatekeeper surveys, and professional clinician focus group interviews. The qualitative methods to be used serve the narrowly defined need for direct and informal opinion on a specific topic and have two major purposes: To obtain information that is useful in formulating policies and regulatory decisions and for developing variables and measures for formulating the basic objectives of risk communication campaigns, and to assess the potential effectiveness of messages and materials in reaching and successfully communicating with their intended audiences.

FDA will use these methods to test and help refine messages and other communications but will generally conduct further research before making important decisions. FDA will use this mechanism to test messages about regulated drug products on a variety of subjects related to consumer, patient, or health care professional perceptions and about use of drug products and related materials, including but not limited to, direct-to-consumer prescription drug promotion, physician labeling of prescription drugs, medication guides, over-the-counter drug labeling, emerging risk communications, patient labeling, online sale of medical products, and consumer and professional education. Annually, FDA projects about 45 communication studies using the variety of test methods listed in this document.

FDA estimates the burden of this collection of information as follows:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

The collection of information supports Agency guidance entitled, “Guidance for Industry on Pharmacogenomic Data Submissions.” The guidance provides recommendations to sponsors submitting or holding investigational new drug applications (INDs), new drug applications (NDAs), or biologics license applications (BLAs) on what pharmacogenomic data should be submitted to the Agency during the drug development process. Sponsors holding, and applicants submitting, INDs, NDAs, or BLAs are subject to FDA requirements for submitting to the Agency data relevant to drug safety and efficacy (21 CFR 312.22, 312.23, 312.31, 312.33, 314.50, 314.81, 601.2, and 601.12).

The guidance interprets FDA regulations for IND, NDA, or BLA submissions, clarifying when the regulations require pharmacogenomics data to be submitted and when the submission of such data is voluntary. The pharmacogenomic data submissions described in the guidance that are required to be submitted to an IND, NDA, BLA, or annual report are covered by the information collection requirements under 21 CFR parts 312, 314, and 601 (approved under OMB control numbers 0910-0014 (part 312, INDs); 0910-0001 (part 314, NDAs and annual reports); and 0910-0338 (part 601, BLAs)), respectively.

The guidance distinguishes between pharmacogenomic tests that may be considered valid biomarkers appropriate for regulatory decisionmaking, and other, less well-developed exploratory tests. The submission of exploratory pharmacogenomic data is not required under the regulations, although the Agency encourages the voluntary submission of such data.

The guidance describes the voluntary genomic data submission (VGDS) that can be used for such a voluntary submission. The guidance does not recommend a specific format for the VGDS, except that such a voluntary submission be designated as a VGDS. The data submitted in a VGDS and the level of detail should be sufficient for FDA to be able to interpret the information and independently analyze the data, verify results, and explore possible genotype-phenotype correlations across studies. FDA does not want the VGDS to be overly burdensome and time-consuming for the sponsor.

In the Federal Register of March 17, 2017 (82 FR 14221), we published a 60-day notice requesting public comment on the proposed extension of this collection of information. One comment was received, however it was not responsive to the four information collection topics solicited in the notice and therefore is not addressed here.

FDA has estimated the burden of preparing a voluntary submission described in the guidance that should be designated as a VGDS based on our experience with these submissions over the past few years, and on our familiarity with sponsors' interest in submitting pharmacogenomic data during the drug development process. In 2013, we received three VGDS. Since 2013, there have been no submission of VGDS; however, for purposes of this information collection approval, we are estimating that we may receive one submission annually. We estimate each submission requires approximately 50 hours to prepare and submit to FDA.

We therefore estimate the burden of this collection of information as follows:

I. Background

Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)) authorizes FDA to conduct research relating to health information. Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to conduct research relating to drugs and other FDA regulated products in carrying out the provisions of the FD&C Act.

Section 502(n) of the FD&C Act (21 U.S.C. 352(n)) specifies that advertisements (ads) for prescription drugs and biological products must provide a true statement of information “in brief summary” describing the advertised product's “side effects, contraindications and effectiveness.” The prescription drug advertising regulations provide further clarification on the information to include in brief summary a true statement of information in brief summary relating to side effects, contraindications to include side effects, warnings, precautions, and contraindications and include any such information under such headings as cautions, special considerations, important notes, etc. and effectiveness (21 CFR 202.1(e)(1)). The prescription drug advertising regulations also specify that the phrase side effect and contraindication refers to all of the categories of risk information contained in the required, approved or permitted product labeling written for health professionals, including the Warnings, Precautions, and Adverse Reactions sections (21 CFR 202.1(e)(3)(iii)). Ads must also “present a fair balance between information relating to side effects and contraindications and effectiveness. . . .” An ad must present true information relating to side effects and contraindications in comparable depth and detail with the claims for effectiveness or safety (21 CFR 202.1(e)(5)(ii)).

To fulfill the regulatory requirements for fair balance and the brief summary, sponsors have typically included risk information about the product in direct-to-consumer (DTC) print ads both in the main part of the ad where the product claims appear, and in a separate brief summary page. The section of the main ad where the risks appear is often referred to as the “Important Safety Information” (ISI). Including risks in both the ISI and the brief summary may have advantages. Some research has found that repetition of information improves recall, especially for older adults (Ref. 1). This might result in improved recall for risks that appear both in the ISI and brief summary. However, it is possible that risks appearing on the main page in the ISI may be more likely to be read than risks appearing in the brief summary. Based on FDA survey research, about 27 percent of consumers surveyed in 2002 reported reading half or more of the brief summary in DTC print ads (Ref. 2). In comparison, when asked how much of the “main” ad they read, about 78 percent reported reading “all” or “almost all” of the main body portion of the ad.

One potential downside to including the same warnings in both the ISI and again in the brief summary is the potential to overwarn consumers. Overwarning is the concept that individuals are exposed to so many warnings in the course of daily life that they are less likely to pay attention to any one particular warning (Ref. 3). In terms of presenting risk information, detailing too many risks may lead consumers to discount all risks, or miss the most important risk information. Similarly, habituation follows when readers see the same warning repeatedly. Upon seeing a particular warning repeatedly, consumers may cease to pay attention to it (Refs. 4 to 6). Even if a warning has features that make it noticeable, it still has the potential for habituation with repeated exposure (Ref. 5). Although researchers caution against habituation and overwarning, there appears to be little empirical research for the logical supposition that seeing repeated warnings will lead to increased selectivity and reduced attention by recipients over time. Of note, the Office of Prescription Drug Promotion (OPDP) is studying the issue of reduced risk information in the context of DTC TV ads (“Disclosure Regarding Additional Risks in Direct-to-Consumer Prescription Drug Television Advertisements,” OMB control number. 0910-0785).

OPDP plans to investigate, through empirical research, how repetition and overwarning apply to the presentation of risks in promotional prescription drug print pieces. We propose to test two levels of the ISI (short versus long) and the presence of the Brief Summary (absent versus present) in two different medical conditions (overactive bladder and rheumatoid arthritis). Figures 1 and 2 describe the study design. This will be investigated in DTC print ads for prescription drugs.

This project is designed to use eye tracking technology to determine how these risk presentations in DTC print ads are perceived. Eye tracking technology is an effective method to determine the extent to which consumers attend to risk information presented in DTC print ads. This technology allows researchers to unobtrusively detect and measure where a participant looks while viewing a print ad and for how long, and the pattern of their eye movements may indicate attention to and processing of information in the ad.

We plan to collect descriptive eye tracking data on participants' attention to the following: (1) The important safety information, (2) the brief summary, and (3) the indication and benefit claims. All participants will be 18 years of age or older. We will exclude individuals who are trained as healthcare professionals, or who work in pharmaceutical, advertising, or marketing settings because their knowledge and experiences may not reflect those of the typical consumer. We will also exclude individuals who have photosensitive epilepsy; use a medical device that is sensitive to infrared light; or wear bifocals, hard contact lenses, or colored contact lenses.

To examine differences between experimental conditions, we will conduct inferential statistical tests such as analysis of variance (ANOVA). With the sample size described in this document, we will have sufficient power to detect small-to-medium sized effects in the main study.

We plan to conduct one 60-minute pilot study with 40 participants and two 60-minute studies with 200 participants each (50 participants in each cell), for a total of 400 main study participants. The studies will be conducted in person in at least five different cities across the United States. The pilot study and main studies will have the same design and will follow the same procedure. Participants who self-identify as having one of the medical conditions of interest will be randomly assigned to one of four test conditions. In Study 1, the ad will be for a fictitious drug to treat rheumatoid arthritis. In Study 2, the ad will be for a fictitious drug to treat overactive bladder. After obtaining consent, we will explain the study procedure to participants and calibrate the eye tracking device. To collect eye tracking data, we will use an unobtrusive glasses-based real world eye tracker with a minimum speed of 50 Hertz. The test images will be presented on paper and sized similarly to how they would appear in print materials such as magazines. To simulate normal ad viewing, participants will view two ads. One of the ads will be the study ad. The non-study ad will be for a consumer product unrelated to health. Only eye tracking data from the study ad will be analyzed. Next, participants will complete a questionnaire that assesses risk perceptions, risk recall, efficacy perceptions, efficacy recall, and covariates such as demographics and health literacy. In the pilot study, participants will also answer questions as part of a debriefing interview to assess the study design and questionnaire.

FDA estimates the burden of this collection of information as follows:

The following references are on display in the Dockets Management Staff (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.

I. Background

Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)) authorizes FDA to conduct research relating to health information. Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to conduct research relating to drugs and other FDA regulated products in carrying out the provisions of the FD&C Act.

Under the FD&C Act and implementing regulations, promotional labeling and advertising about prescription drugs are generally required to be truthful, non-misleading, and to reveal facts material to the presentations made about the product being promoted (see sections 502(a) and (n), and 201(n) of the FD&C Act (21 U.S.C. 352(a) and (n), and 321(n)); see also 21 CFR 202.1). As a part of the ongoing evaluation of FDA's regulations in this area, FDA is proposing to study the impact of disclosures as they relate to presentations of preliminary or descriptive scientific and clinical data in promotional labeling and advertising for oncology products. The use of disclosures is one method of communicating information to health care professionals about scientific and clinical data, the limitations of that data, and practical utility of that information for use in treatment. These disclosures may influence prescriber comprehension and decisionmaking, and may affect how and what treatment they prescribe for their patients.

Pharmaceutical companies market directly to physicians through publishing advertisements in medical journals, exhibit booths at physician meetings or events, sending unsolicited promotional materials to doctors' offices, or presentations (“detailing”) by pharmaceutical representatives (Ref. 1). Detail aids may contain carefully extracted data from clinical studies that, taken out of context, can exaggerate the benefits of a drug (Ref. 2) or contribute to physicians prescribing the drug for an inappropriate patient population.

Promotional labeling and advertising for cancer drugs deserve specific attention. Oncology drugs represented 26 percent of the 649 compounds under clinical trial investigation from 2006 to 2011 (Ref. 3). The past decade has seen a dramatic rise in the number of oncology drugs brought to market. In the past 18 months, FDA has approved 27 cancer drugs (Ref. 4). Although overall survival remains the gold standard for demonstrating clinical benefit of a drug, several additional endpoints are accepted as surrogates illustrating clinical benefit with regard to cancer and many drugs are granted expedited approval on their basis. These include disease-free survival, objective response rate, complete response rate, progression-free survival, and time to progression (Ref. 5). For clinicians who are not specifically trained in clinical trial design, interpreting these endpoints may be challenging. Pharmaceutical companies invest heavily in the development and distribution of promotional materials to educate oncologists about favorable clinical trial results.

When communicating scientific and clinical data, a disclosure (a specific statement that modifies or qualifies a claim) could be used to convey the limitations of the data and practical utility of the information for treatment. Much of the prior research on disclosures in this topic area has been limited to the dietary supplement arena with consumers (Refs. 6-9). Disclosures in professional pieces could influence prescriber comprehension as well as subsequent decisionmaking; however, no published data exist regarding how prescribers use and understand scientific claims in conjunction with qualifying disclosures.

Different aspects of disclosures may influence their effectiveness. For example, despite the advanced education of health care providers, in a busy practice they may not be willing or able to process the disclosures thoroughly. Thus, the level of technicality in the disclosure may play a role in their use of the disclosure to contextualize the data display. Additionally, the addition of a general summary statement to frame the disclosure may help or hinder the processing of the disclosure and therefore the entire data display. Finally, it is possible that the impact of disclosure statements on prescriber comprehension, perceptions, and intentions to prescribe the promoted product will vary based on the level of clinical training. Although oncologists and primary care physicians (PCPs) will have more experience with clinical data, mid-level practitioners have reported having significantly more formal training on pharmaceutical marketing tactics than specialists and PCPs (Ref. 10). Therefore, it is unclear whether any one group would be more or less affected by both the claims made in promotional materials or by the disclosures that accompany those claims.

The proposed study seeks to address the following research questions:

1. Do disclosures mitigate potentially misleading presentations of preliminary or descriptive data in oncology drug product promotion?

2. Does the language (technical, non-technical) of the disclosure influence the effectiveness of the disclosure?

3. Does the presence of a general statement about the clinical utility of the data in addition to a specific disclosure influence processing of claims and disclosures?

4. Do PCPs, oncologists, and mid-level practitioners (nurse practitioners, physician assistants) differ in their processing of claims and disclosures about preliminary or descriptive data?

5. Which disclosures do physicians prefer?

To address these questions, FDA has designed a study that will be conducted in three independent phases, each phase examining a data display in a promotional piece for a unique oncological product. Independent variables will include: (1) Specific disclosure (technical, non-technical, none), (2) general statement (present, absent), and (3) specialty (oncologists, PCPs, mid-level practitioners). Each phase will have the following design:

Specific disclosures will include material information specifically related to the particular data display in question. As such, each specific disclosure may include clinical or statistical information related to the trial design, the statistical analysis plan of the trial, or any other material statistical or clinical information necessary for evaluation or interpretation of the data. The team developing the disclosures includes social science analysts, pharmacists, oncological medical officers, and an oncology nurse. An example of the general statement is “This presentation includes exploratory information of uncertain clinical utility and should be interpreted cautiously when used to make treatment decisions.”

Outcome variables will focus on the assessment of the data display as a whole as well as attention to the disclosure, if present. Specifically, we will examine recognition of the clinical endpoint in the data display, comprehension of the data display, perceptions of the exploratory nature of the data, and the perceived credibility of the promotional piece. We will also look at attention to the specific disclosure and the general statement, prescriber decisions, and prescriber preferences. This latter outcome variable will be determined by a secondary task at the end of the questionnaire that shows each participant all disclosure options and asks them to choose their preferred version.

Oncologists, PCPs, and non-oncology mid-level practitioners will be recruited to participate via the Internet, and the study is expected to take approximately 20 minutes. Participants will view professionally developed promotional pieces that mimic currently available promotion and answer questions. The questionnaire is available upon request.

FDA estimates the burden of this collection of information as follows:

The following references are on display in the Dockets Management Staff (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.