Title: Importation of Hass Avocados from Michoacan, Mexico.

OMB Number: 0579-0129.

Type of Request: Extension of approval of an information collection.

Abstract: The Plant Protection Act (PPA, 7 U.S.C. 7701 et seq. ) authorizes the Secretary of Agriculture to restrict the importation, entry, or interstate movement of plants, plant products, and other articles to prevent the introduction of plant pests, including avocado stem weevils, seed weevils, and seed moths, into the United States or their dissemination within the United States. Regulations authorized by the PPA concerning the importation of fruits and vegetables into the United States from certain parts of the world are contained in “Subpart-Fruits and Vegetables” (7 CFR 319.56-1 through 319.56-50).

Under these regulations, avocados from Michoacan, Mexico, are subject to certain conditions before entering the United States. These requirements include, among other things, trust fund agreements, work plans, phytosanitary certificates, stickers, truck and container seals, and box marking.

We are asking the Office of Management and Budget (OMB) to approve our use of this information collection activity 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 0.0015068 hours per response.

Respondents: Importers, shippers, Mexican officials.

Estimated annual number of respondents: 20,178.

Estimated annual number of responses per respondent: 4,078.

Estimated annual number of responses: 82,283,974.

Estimated total annual burden on respondents: 123,985 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.

Under the regulations in “Subpart—Fruits and Vegetables” (7 CFR 319.56-1 through 319.56-50, referred to below as the regulations), the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture prohibits or restricts the importation of fruits and vegetables into the United States from certain parts of the world to prevent plant pests from being introduced into and spread within the United States.

There are two pests of concern associated with the importation of garlic ( Allium sativum L.) from most countries in the world: Weevils in the genus Brachycerus spp. and the moth larvae Dyspessa ulula. Both of these pests have stages that may feed internally in the garlic cloves.

Currently, several countries are authorized to export garlic (dry bulbs, no green leaves) to the United States only if the commodity undergoes vacuum fumigation with methyl bromide for Brachycerus spp. and D. ulula. These countries are Algeria, Armenia, Austria, Azerbaijan, Belarus, Bosnia and Herzegovina, Bulgaria, Croatia, Czech Republic, Egypt, Estonia, Georgia, Germany, Greece, Hungary, Israel, Kazakhstan, Kyrgyzstan, Latvia, Lebanon, Lithuania, the Republic of Macedonia, Moldova, Montenegro, Morocco, Palestine Authority, Portugal, Romania, Russian Federation, Serbia, Slovakia, Slovenia, Switzerland, Syria, Tajikistan, Turkey, Turkmenistan, Ukraine, and Uzbekistan. In this document, we refer to them as the European Union (EU) and other countries.

Section 319.56-4 contains a performance-based process for approving the importation of commodities that, based on the findings of a pest risk analysis, can be safely imported subject to one or more of the designated phytosanitary measures listed in paragraph (b) of that section. These measures are:

• The fruits or vegetables are subject to inspection upon arrival in the United States and comply with all applicable provisions of § 319.56-3;

• The fruits or vegetables are imported from a pest-free area in the country of origin that meets the requirements of § 319.56-5 for freedom from that pest and are accompanied by a phytosanitary certificate stating that the fruits or vegetables originated in a pest-free area in the country of origin;

• The fruits or vegetables are treated in accordance with 7 CFR part 305;

• The fruits or vegetables are inspected in the country of origin by an inspector or an official of the national plant protection organization of the exporting country, and have been found free of one or more specific quarantine pests identified by the risk analysis as likely to follow the import pathway; and/or

• The fruits or vegetables are a commercial consignment.

APHIS received a request from the Government of Egypt to allow the importation of garlic bulbs from Egypt into the continental United States without vacuum chamber fumigation. We have prepared a commodity import evaluation document (CIED) to evaluate whether vacuum fumigation is necessary to mitigate the risk from Brachycerus spp. and D. ulula. We have concluded that garlic can be safely imported into the continental United States from the EU and other countries without vacuum fumigation by using one or more of the five designated phytosanitary measures listed in § 319.56-4(b).

Therefore, in accordance with § 319.56-4(c), we are announcing the availability of our CIED for public review and comment. The CIED may be viewed on the Regulations.gov Web site or in our reading room ( see ADDRESSES above for instructions for accessing Regulations.gov and information on the location and hours of the reading room). You may request paper copies of the CIED by calling or writing to the person listed under FOR FURTHER INFORMATION CONTACT. Please refer to the subject of the CIED when requesting copies.

After reviewing the comments we receive, we will announce our decision regarding the import status of garlic from the European Union and other countries in a subsequent notice. If the overall conclusions of the CIED and the Administrator's determination of risk remain unchanged following our consideration of the comments, then we will begin issuing permits for importation of garlic from the EU and other countries into the continental United States subject to the requirements specified in the CIED.

Under the regulations in “Subpart—Fruits and Vegetables” (7 CFR 319.56-1 through 319.56-50, referred to below as the regulations), the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture prohibits or restricts the importation of fruits and vegetables into the United States from certain parts of the world to prevent plant pests from being introduced into and spread within the United States.

Section 319.56-4 contains a performance-based process for approving the importation of commodities that, based on the findings of a pest-risk analysis, can be safely imported subject to one or more of the designated phytosanitary measures listed in paragraph (b) of that section. These measures are:

• The fruits or vegetables are subject to inspection upon arrival in the United States and comply with all applicable provisions of § 319.56-3;

• The fruits or vegetables are imported from a pest-free area in the country of origin that meets the requirements of § 319.56-5 for freedom from that pest and are accompanied by a phytosanitary certificate stating that the fruits or vegetables originated in a pest-free area in the country of origin;

• The fruits or vegetables are treated in accordance with 7 CFR part 305;

• The fruits or vegetables are inspected in the country of origin by an inspector or an official of the national plant protection organization of the exporting country, and have been found free of one or more specific quarantine pests identified by the risk assessment as likely to follow the import pathway; and/or

• The fruits or vegetables are a commercial consignment.

APHIS received a request from the Government of the Republic of South Africa to allow the importation of fresh persimmon fruit ( Diospyros kaki ) from the Republic of South Africa into the continental United States. We have completed a pest risk assessment for this commodity to identify pests of quarantine significance that could follow the pathway of importation into the United States and, based on this list, have prepared a risk management document to identify phytosanitary measures that could be applied to fresh persimmon fruit from the Republic of South Africa to mitigate the pest risk. We have concluded that fresh persimmon fruit can be safely imported into the continental United States from the Republic of South Africa using one or more of the five designated phytosanitary measures listed in § 319.56-4(b). Therefore, in accordance with § 319.56-4(c), we are announcing the availability of our pest risk analysis for public review and comment. The pest risk analysis may be viewed on the Regulations.gov Web site or in our reading room ( see ADDRESSES above for a link to Regulations.gov and information on the location and hours of the reading room). You may request paper copies of the pest risk analysis by calling or writing to the person listed under FOR FURTHER INFORMATION CONTACT. Please refer to the subject of the pest risk analysis you wish to review when requesting copies.

After reviewing any comments we receive, we will announce our decision regarding the import status of fresh persimmon fruit from the Republic of South Africa in a subsequent notice. If the overall conclusions of the analysis and the Administrator's determination of risk remain unchanged following our consideration of the comments, then we will begin issuing permits for the importation of fresh persimmon fruit from the Republic of South Africa into the continental United States subject to the requirements specified in the risk management document.

Title: Evaluation of the Quantity and Quality of Nutritional Information Available to School Food Authorities about Food Service Products and Commodities.

OMB Number: [0584-NEW].

Expiration Date: [Not Yet Determined.]

Type of Request: [New Collection].

Abstract: The purpose of this evaluation is to fulfill the requirements of Section 242 of the Health, Hunger-Free Kids Act of 2010 (the Act). The Act amended Section 9(a)(4) of the Richard B. Russell National School Lunch Act, 42 U.S.C. 1758(a)(4), and requires the Secretary to, not later than 1 year after the date of enactment of the Act, carry out a study to analyze the quantity and quality of nutritional information available to school food authorities about food service products and commodities. In addition, the Secretary must also submit to Congress a report on the results of the study that contains such legislative recommendations as the Secretary considers necessary to ensure that school food authorities have access to the nutritional information needed for menu planning and compliance assessments within 1 year after enactment of the Act.

To conduct this study, FNS will work with our external partners, such as State agencies and the School Nutrition Association, to disseminate the survey to school foodservice professionals. The study will assess the quality and quantity of nutrition information available to school food authorities (SFAs) during both the ordering and delivery periods. The questions posed in the study will help FNS better understand purchasing decisions and will ultimately allow FNS to make recommendations to ensure SFAs can effectively and efficiently obtain accurate nutrition information needed for purchasing the widest variety of healthful foods, menu planning and undertaking compliance assessments.

Affected Public: State, Local and Tribal Government. Respondent groups identified include current school foodservice professionals sampled from across the United States.

Estimated Number of Respondents: Approximately 500 school foodservice professionals will participate in the benchmark survey as part of the study. This is based on an estimated completion rate with a previous FNS survey conducted through the School Nutrition Association's membership list.

Estimated Number of Responses per Respondent: The school foodservice professionals will be asked to respond to a survey once.

Estimated Total Annual Responses: 500 (500 respondents × 1 response).

Estimated Time per Response: .25 (the estimated time is approximately 15 minutes).

Estimated Total Annual Burden on Respondents: 5,000 minutes (125 hours). See the table below for estimated total annual burden for each type of respondent.

FSIS is the public health regulatory agency in USDA that is responsible for ensuring that the nation's commercial supply of meat, poultry, and processed egg products is safe, wholesome, and appropriately labeled and packaged. FSIS is a participant in the President's Food Safety Working Group (FSWG), which was created by President Obama in March 2009 to recommend improvements to the U.S. food safety system. The FSWG is chaired by Secretary of Agriculture Tom Vilsack and Health and Human Services Secretary Kathleen Sebelius. In July 2009, the FSWG published Key Findings recommending a new, public health-focused approach to food safety based on three core principles: Prioritizing prevention, strengthening surveillance and enforcement, and improving response and recovery.

The FSWG specifically charged FSIS with “cutting Salmonella risk in Poultry Products” by “develop[ing] new standards to reduce the prevalence of Salmonella in turkey and poultry” and by “establish[ing] a Salmonella verification program with the goal of having 90 percent of poultry establishments meeting the new standards by the end of [calendar year] 2010.” (FSWG) These new Salmonella standards are to be applied to sample sets from establishments included in the Agency's Salmonella Verification Program in the place of the performance standards for young chickens (as broilers) codified at 9 CFR 381.94 and the standards for turkeys announced in a Federal Register Notice of February 17, 2005. The Agency intends to issue a proposed rule that would formally rescind the codified standards that are no longer in effect. In consultations with the FSWG, the Agency committed to a number of other food safety initiatives to prevent illness, among them developing a new performance standard for Campylobacter for young chickens and turkeys.

The Agency accordingly published a Federal Register Notice on May 14, 2010 (75 FR 27288) in which it announced the July 2010 implementation of new performance standards for the pathogenic micro-organisms Salmonella and Campylobacter for chilled carcasses in young chicken and turkey slaughter establishments. The May 14, 2010 notice announced that FSIS had developed such performance standards and predicted the public health impact that might result if, after two years of implementation, these standards are met by half of the establishments that would not meet them at first. The new performance standards for young chickens and turkeys were informed by, among other data sources, data collected during the Agency's recent Nationwide Microbiological Baseline Data Collection Programs: The Young Chicken Baseline Survey (YCBS), and the Young Turkey Baseline Survey (YTBS) ( Baselines ). The May 14, 2010 notice detailed the baseline surveys and their use in developing the new performance standards.

Although FSIS had planned to implement the new standards in July 2010, the Agency decided to delay implementation until the many comments filed in response to the May 14, 2010 notice had been evaluated. This current notice responds to those comments and explains the policy changes made by the Agency based on its careful evaluation of the comments. These policy changes are listed in the notice Summary above and are further detailed in the responses to comments below.

The Agency cannot yet determine if it has met the FSWG goal of having 90 percent of poultry establishments meeting the new Salmonella standards by the end of Calendar Year (CY) 2010 as Salmonella verification set scheduling and sampling is an ongoing process and a number of establishments that started sets in CY 2010 were not completed by December 31, 2010. Partial sets are incommensurate, moreover, with the completed-set-based performance measures used by the Agency and the FSWG. Therefore, in preparing its CY 2010 accounting for this FSWG goal, FSIS plans to complete sample sets started in 2010 or earlier during the first quarter of 2011 and count those completed sets toward its final 2010 report. The Agency will cut off its 2010 sample set total on April 1, 2011 and issue its final 2010 accounting at that point. Any 2010-started sample sets not completed by April 1 will be applied toward CY 2011 totals once completed. The final CY total will thus comprise sets started no later than December 31, 2010 and completed no later than March 31, 2011. As of March 2011, 86.2 percent of young chicken slaughter establishments would have met the new standard for 2010. Also as of March 2011, 87.8 percent of young turkey slaughter establishments would have met the new standard for 2010.

The Agency believes that the policy changes announced in this notice, which will be implemented in July 2011, will encourage the poultry industry to reduce Salmonella in poultry and thereby further reduce the risk of human illnesses.

Foreign countries that are eligible to export poultry products to the United States must apply inspection, sanitary, and other standards that are equivalent to those that FSIS applies to poultry products. Thus, in evaluating a foreign country's poultry inspection system to determine the country's eligibility to export products to the United States, FSIS will consider whether Salmonella or Campylobacter methods and procedures that the country applies are equivalent to those that FSIS uses.

Some comments claimed that the Agency is violating the Administrative Procedure Act (APA) by effectively promulgating a “regulation” without following due notice-and-comment procedure.

FSIS Response: The Agency does not agree that FSIS policies explained herein are regulations subject to notice-and-comment requirements under the APA or are otherwise in violation of the APA. The policies and performance standards, including the testing process the Agency will undertake, do not impose requirements on establishments. We would note, however, that the Agency has sought to engage industry and all interested parties in the subject matter of this notice, has provided extensive opportunity for public comment, delayed implementation to carefully consider issues that were raised in comments, and made various substantive changes to policies based on those comments. We would also note that this is not a novel approach and that notice establishing standards against which to measure establishment performance has been accomplished before through Federal Register notices in 2005 (70 FR 8058) and 2006 (71 FR 9772) (referenced in the May 14, 2010 notice). In 2008, FSIS further articulated how the Agency intended to evaluate whether industry was adequately controlling for Salmonella in carcasses (73 FR 4767).

Several comments expressed opposition to the Agency's decision to apply the new standards requiring fewer positives for Category 1 status than has been the case and that posting Category 2 establishments unrealistically differentiates such establishments from those in Category 1.

FSIS Response: The Agency believes that its policy of posting establishments that are not in the highest performance rank has stimulated improvement in industry performance, as was shown in the Agency's experience after announcing performance categories in 2006 when 55-60 percent of non-compliant establishments moved to become compliant within two years. FSIS, however, recognizes that some establishments that have been excluded from posting may now be included based on the same level of performance. While the Agency will implement updated Salmonella and new Campylobacter performance standards for young chickens and turkeys with Agency verification sample sets scheduled for July 2011, establishments that complete sample sets begun in or after July 2011 will be Web-posted only if they have failed the new standards. Web-posting of Category 2 and 3 establishments that began sets under current standards will continue until these establishments have completed sets under the new standards.

Effective with samples sets starting in or after July 2011, Salmonella performance Categories 1 and 2, based on the new performance standards, will be applied exclusively for Agency internal analysis and not for posting purposes. The Agency will post quarterly aggregate reports showing the Category 1/2/3 distribution for each relevant product class subject to FSIS Salmonella testing but will not identify individual establishments. In order to accomplish this, the Agency will determine Category 1 and 2 performance criteria for young turkey establishments.

The Agency believes that this policy change is reasonable given the general progress of the poultry industry in reducing positive rates from the 1996 HACCP baselines to current rates. Though the “pass-fail” approach is to be taken with young chickens now as well as turkeys, as stated in the May 14, 2010 notice, the smaller prevalence on young turkey carcasses permits a less stringent compliance criterion that is consistent with the Agency's stated objectives of substantially reducing pathogen presence. Thus, the young chicken standard allows an establishment operating at the baseline prevalence approximately an 80 percent chance of passing. The turkey standard, however, is based on a much lower prevalence and so the turkey standard's higher chance of passing of 99+ percent is appropriate.

Several comments doubted that there is a connection between Salmonella contamination of chicken carcasses and the occurrence of cases of human salmonellosis.

FSIS Response: The Agency believes that there is a connection between Salmonella contamination and human illness, and that poultry contamination continues to contribute significantly to salmonellosis. Evidence of the connection of salmonellosis and contaminated chicken products can be found in the outbreaks that have been associated with chicken (CDC food borne outbreaks) and a 2004 case control study conducted by the Centers for Disease Control and Prevention (CDC) that has linked salmonellosis with chicken products (A.C. Kimura et al.; Kimura et al. study). Furthermore, in a Memorandum to the Record dated January 18, 2011, CDC re-affirmed that “Poultry products are an important vehicle for human Salmonella and Campylobacter infections in the United States” (posted with this notice at http://www.fsis.usda.gov/Regulations_&_Policies/2011_Notices_Index/index.asp ). Since raw chicken products (ground and carcasses) continue to show greater Salmonella prevalence than is found with other product classes (Salmonella Testing Tables), it is likely that the source of the contamination was chicken carcasses rather than other non-chicken ingredients such as spices that may be used with such products. The Agency has concluded, using the available data and the best science available, that reducing Salmonella on chicken carcasses would reduce risk of illness and thus potentially reduce the occurrence of illnesses.

The Agency further notes, however, that the commenter's evidence to support the assertion of no connection was based on the human illness FoodNet database ( see discussion below). Salmonellosis cases due to poultry are only a subset of all salmonellosis cases reported through the CDC FoodNet program. The total number of salmonellosis cases stem from all sources including cattle, swine, eggs, fish, fruits and vegetables. Thus an observed correlation (negative or positive) between Salmonella occurrence in poultry carcasses at post chill and salmonellosis from FoodNet data cannot be used to assert a causal relationship between poultry contamination and salmonellosis. Further, the available salmonellosis data cannot be stratified by food vehicle ( e.g., poultry), given the lack of food attribution data within the FoodNet database. Given this data gap, it is entirely conceivable that a reduction of salmonellosis due to one food product such as poultry could be negated by an increase in salmonellosis due to another product or unrelated vehicle. In any case, the Agency believes that the available evidence leads to the conclusion that Salmonella occurrence in poultry has the potential to cause salmonellosis in humans.

Several comments from industry argued that tightening Salmonella performance standards since 2006 has not resulted in fewer cases of human salmonellosis and thus that further tightening the standards would be pointless and punitive. They argue that available evidence (from CDC FoodNet data sets) did not support the Agency's predictions that there would be benefits derived from decreases in Salmonella found on carcasses at post chill.

FSIS Response: There are important reasons why it is not appropriate to examine CDC salmonellosis rates and compare these data directly to trends of Salmonella incidence for inferring the impact of reduction of Salmonella incidence for any particular commodity and salmonellosis rates. Specifically, it is important to distinguish the two surveillance datasets available from the CDC used to analyze outbreak trends and foodborne illness. First, the CDC National Outbreak Reporting System (NORS) ( http://wwwn.cdc.gov/foodborneoutbreaks/ ), referred here as outbreak data, provides information on reported outbreaks (defined as two or more illnesses associated with a single vehicle (product) that caused the illness). The source of the contamination is investigated (the pathogen and food product responsible for the outbreak); however, about 50 percent of confirmed Salmonella outbreaks do not have a known food vehicle. Second, the Foodborne Diseases Active Surveillance Network (FoodNet) ( http://cdc.gov/foodnet/ ) produces annual case rates for several major foodborne pathogens, including Salmonella. FoodNet data tracks salmonellosis cases presently in 10 states, presently covering about 1/7 of the U.S. population (46 million). The majority of reported FoodNet cases reflect sporadic cases of Salmonella (for example, only six percent of 2007 reported FoodNet cases were outbreak-related (2007 annual report). There is no information regarding the food product that was (or might have been) associated with the illness. Therefore, FoodNet data are only available as aggregated information from cases due to all sources thought to be foodborne, including all food products such as those categories of foods defined by the CDC—including fish, crustaceans, mollusks, dairy, eggs, beef, game, pork, poultry, grains-beans, oils-sugars, fruits-nuts, fungi, leafy vegetables, root vegetables, sprout, vine-stalk vegetables (Painter et al., 2009; Painter et al.). Thus an observed correlation (negative or positive) between Salmonella occurrence in chicken carcasses at post chill and FoodNet salmonellosis cannot be used, by itself, to assert a causal relationship between chicken contamination and salmonellosis. Unfortunately, as mentioned above, the FoodNet database reflecting trends of salmonellosis rates cannot be stratified by food vehicle ( e.g., chicken), given the lack of food attribution data. However, for all food sources, the incidence of Salmonella -caused human illness declined approximately eight percent from the beginning of surveillance in 1996 to the most recently released annual report case rate in 2007 (as opposed to the most recently released preliminary report in 2009), with most of the reductions in the earlier years. This trend (or lack of trend) though cannot be assumed true for product-specific trends: It is possible that reduction of salmonellosis due to one food product such as chicken could be negated by the increase in salmonellosis due to another product or unrelated vehicle, such as produce, thus causing the stable case rate in recent years. Consequently, even if there is not a positive correlation of salmonellosis rates and the incidence of contamination rates on young chicken carcasses over time, it would not be possible to dismiss the likelihood that Salmonella occurrence in chicken and salmonellosis are causally connected.

The data presented above are part of a weight of evidence approach to refute the assertion that there is no connection between the presence of Salmonella on broilers and human illnesses. Additional evidence can be gleaned by performing trend analyses comparing either CDC outbreak data or the serotype data contained within FoodNet to FSIS verification results (FSIS Serotype Data).

Some comments questioned the validity of applying Campylobacter performance standards, given the fragility of the organism and the relatively low risk associated with all but highly-contaminated servings or samples.

FSIS Response: After evaluating comments pointing out the complexities of Campylobacter and considering the Agency's lack of experience with verification sampling for this organism, FSIS has decided that it will track and report Campylobacter results to establishments and will not post the names of establishments that fail to meet the new Campylobacter standards. The Campylobacter performance standards and sample set criteria for tracking and reporting to establishments will be applied to results from the smaller of the two laboratory Campylobacter sample portions (1 mL) described in the May 14, 2010 Notice, which detects higher levels of contamination. The Campylobacter sample set criteria for tracking and reporting 1 mL results are eight positive samples acceptable per 51-sample set for young chickens and three positive samples acceptable per 56-sample set for turkeys. Campylobacter results from the larger of the two laboratory Campylobacter sample portions (30 mL for chickens, sponge plus 24 mL sponge diluent for turkeys), which detects lower levels of contamination, will be used for Agency internal analysis. Agency responses to Campylobacter sample set results will follow current Salmonella procedures for immediate follow-up testing for both organisms and for Food Safety Assessments (FSAs) when deemed necessary.

The Agency notes that the implementation of Campylobacter standards and sampling in July 2011 will mean that all poultry establishments will move to the highest priority in the Agency scheduling algorithm as “new” establishments. Each set scheduled under the new standards will be tested for both Campylobacter and Salmonella. Furthermore, any establishment that fails a set for either organism will be moved to the second-highest priority for scheduling to conduct an immediate follow-up set, and the samples taken in the follow-up set will be analyzed for both organisms. FSIS believes that this more intensive sampling approach will provide a significant incentive for establishments to increase process control for both pathogens.

Category 1/2/3 results will be posted in quarterly aggregate reports for all establishments producing raw products subject to FSIS Salmonella testing, including young chickens and turkeys under the new standards including Campylobacter . FSIS will evaluate industry performance trends with regard to both Salmonella and Campylobacter . In response to adverse trends, the Agency may consider actions that could include, among other things, posting young chicken and turkey Category 2 establishments, posting all establishments that fail any applicable performance standards, or posting non-categorized individual sample set results from all establishments producing raw products subject to such testing. Any such actions would be announced in a Federal Register notice.

Some comments criticized the Agency's predictions of illness reduction, including (1) the assumptions used, and (2) that such reductions were not possible because the standard would primarily affect small volume establishments (Potential Public Health Impact).

FSIS Response: FSIS notes here that the public health predictions made in the May 14, 2010 Federal Register notice were derived from the latest available illness-attribution data published by the CDC in 1999. Updated data have been published recently by the CDC (CDC updated data). The Agency has adjusted its public health predictions accordingly. These public health predictions depend on establishments that currently do not pass the new performance standards changing their processes to pass. Although FSIS has some historic evidence regarding industry behavior in response to previous measures ( i.e., Salmonella HACCP verification program data and categorization of establishments in that program [FSIS 2006]), the true behavior of the industry in response to the new performance standards is unknowable in advance. If the status quo remains and no establishments change their processes to meet the new performance standards, zero illnesses will be avoided. Alternatively, approximately 40,000 illnesses could be avoided if all initially noncompliant establishments were to become compliant. Based on the past performance of the industry to the previous guidance where approximately 50 percent of noncompliant establishments became compliant (FSIS, 2006), FSIS now predicts that two years after implementing the Salmonella standards, human illnesses due to Salmonella could decrease by approximately 20,000 per year.

The case of Campylobacter is somewhat different, in that the Agency will be tracking industry performance and will expect to see improvement rather than stasis or regression. If the Agency, as stated above, sees adverse trends with Campylobacter, it may take various mitigation actions. These public health predictions depend on establishments that currently do not pass the new performance standards changing their processes to pass. Although FSIS has some historic evidence regarding industry behavior in response to previous measures ( i.e., Salmonella HACCP verification program data and categorization of establishments in that program [FSIS 2006]), the true behavior of the industry in response to the new performance standards is unknowable in advance. If the status quo remains and no establishments change their processes to meet the new performance standards, zero illnesses will be avoided. If all initially noncompliant establishments were to become compliant, approximately 11,000 illnesses due to Campylobacter could be avoided. Based on the past response of the industry to the previous guidance where approximately 50 percent of noncompliant establishments became compliant (FSIS, 2006), the Agency predicts that, two years after implementation, as many as 5,000 fewer cases of human illness due to Campylobacter might occur each year. The Agency's detailed response to comments on its approach to making public health predictions is contained in Appendix I.

Comments noted that the Agency's Young Turkey Baseline Survey (YTBS) found 0.35 percent of post-chill samples positive for Salmonella and asked the Agency to explain the discrepancy between the YTBS and FSIS HACCP verification sampling results. In light of the lowered performance standards and these other concerns, comments requested a “grace period” for turkey establishments failing under the new standards, using an average over two sets before posting establishments.

FSIS Response: As an initial matter, FSIS notes and regrets the error in the report “The Nationwide Microbiological Baseline Data Collection Program: Young Turkey Survey August 2008—July 2009” where the report erroneously stated that 0.35 percent of the analyzed post chill samples were found with Salmonella; in the report FSIS also correctly stated that “The estimated prevalence for Salmonella was 1.73 percent * * *” (pages 9 and 11). Reference was made to a technical report: “Technical Paper for Performance Guidance for Broilers and Young Turkey at Post-chill,” that explains the estimation procedure used (Technical Paper). In that technical report, FSIS addressed this issue of the difference of percentages of positive results between the two sampling programs. The comparison between the percentages of positive Salmonella results showed a higher percentage with the HACCP verification sampling, though the difference was not statistically significant. A more detailed response to these comments is attached in Appendix II.

Comments on the proposed Campylobacter performance standards for chickens and turkeys suggest removing the larger sample test portion of the compliance criteria (30 mL for chickens and sponge plus 24 mL sponge diluent for turkeys). Remaining would be the test to detect relatively high levels based on analyses of 1 mL portions for chickens and turkeys.

FSIS response: The Agency believes that a performance standard based on the 1 mL is most efficient in that it targets samples with higher levels of Campylobacter, which have a greater probability of inducing human illness by cross-contamination and surviving cooking compared to lower levels. The performance criteria (number of positive samples acceptable per sample set) for tracking and reporting to establishments will be eight positive samples acceptable per 51-sample set for young chickens and three positive samples acceptable per 56-sample set for turkeys. Data collected for the 30 and sponge plus 24 mL sponge diluent enrichment will be used primarily for Agency internal analysis but will also be aggregated and posted quarterly by performance category to show the progress of the chicken and turkey industries. If there is no improvement in these data over time, FSIS may consider implementing the performance standard using the larger-portion sample results as well.

Comments cited studies claiming that the threshold of concern for Campylobacter in broilers is much higher than the new Campylobacter performance standard and questioned the standard's relevance to public health.

FSIS Response: The threshold dose-response concept implies that there is a very low probability of illness below a certain dose. The 500 Colony Forming Units/gram (CFU/g) threshold suggested would translate into roughly 50,000 CFU as a minimum dose to cause illness assuming a serving of about 100 grams. This assertion is in contrast to the available data. Campylobacter human feeding trials show human illness can result in healthy adult males fed 500 CFU and 800 CFU (Robinson, 1985; Black et al., 1988). If such low levels can result in human illness among healthy adult males, it is reasonable to assume that lower doses might result in human illness in traditionally sensitive populations, such as the young, the old, and the immuno-compromised. Given these concerns, the Agency believes that establishing a performance standard from baseline data is warranted.

A comment stated that the Campylobacter organism is very fragile and is unlikely to survive regular processing and handling and thus questioned the need or usefulness of creating a performance standard for it.

FSIS Response: The FSIS Young Chicken Baseline Survey, 2007-2008, found about 46 percent of sampled chicken carcasses at post-chill had Campylobacter. FSIS does not have data to confirm or deny the presence of Campylobacter on finished product or at retail. However, two Consumer Reports of retail sampling programs for leading national brands of young chickens, published in January of 2007 and 2010 respectively, found about 81 and 62 percent of retail young chickens contaminated with Campylobacter (Consumer Reports). Given the limited sampling, these results cannot be generalized to the retail market as a whole. In addition, however, the National Antibiotic Resistance Monitoring System (NARMS) annual retail meat survey reported that between 2002 and 2008 the incidence of Campylobacter on chicken breasts was between approximately 40 and 60 percent (NARMS).

As Campylobacter does not grow at normal distribution temperatures, it is likely that Campylobacter organisms are able to survive the commercial processes and current interventions employed by the industry. In view of these facts, the Agency believes that it is appropriate to apply Campylobacter standards for tracking and reporting to establishments and for Agency internal analysis, follow-up testing, and Food Safety Assessments when deemed necessary.

Several comments asked for clarification on appropriate methods for use by establishments to verify compliance with the new Campylobacter standards.

FSIS Response: The Agency testing program to verify establishment performance against the new standards will collect young chicken rinsates and turkey carcass sponges to be tested for Campylobacter using a method described in the Microbiology Laboratory Guidebook (MLG), which is available on the FSIS Web site at http://www.fsis.usda.gov/PDF/MLG_41_00.pdf. Contrary to a misleading note in the May 14, 2010 notice implying that the method was being significantly revised, no substantive changes to this method are anticipated at this time.

The MLG 41 method for poultry rinsates and carcass sponges is designed to be selective for the Campylobacter species of interest. FSIS will perform testing for detection and enumeration of Campylobacter jejuni, C. coli, and C. lari. According to CDC data, C. jejuni and C. coli cause the majority of Campylobacter illnesses in the U.S. The National Advisory Committee for Microbiological Criteria of Foods (NACMCF) recommended the use of methodology to specifically target these Campylobacter species so FSIS encourages industry testing to include these species.

The MLG method includes two procedures. In the first procedure (MLG 41 Section 41.5), an aliquot of the rinsate or sponge/buffered peptone water (BPW) combination is plated directly to the Campy-Cefex plating medium and then incubated under microaerophilic conditions for 48 hours at 42 °C.

In the second procedure (MLG 41 Section 41.6.1 or 41.6.2), an aliquot of rinsate or sponge/BPW combination is cultured in blood free Bolton enrichment broth plus Bolton broth selective supplements under microaerophilic conditions for 48 hours at 42 °C and then a small amount of enriched culture is streaked to Campy-Cefex plating medium and incubated under microaerophilic conditions for 48 hours at 42 °C.

The theoretical limit of detection is considerably higher for the direct plating sample compared with the enriched sample. For both procedures, multiple colonies that are typical of the appearance of Campylobacter are picked from the Campy-Cefex plating medium and confirmed as Campylobacter jejuni, coli, or lari (Campylobacter j/c/l ) using microscopy to assess cell morphology and motility, and a latex agglutination serological testing procedure that identifies Campylobacter specifically belonging to these three species. To determine establishment performance relative to the performance standards, samples by the direct plating procedure with one or more colonies confirmed as Campylobacter j/c/l would be considered positive. Samples positive by either or both procedures will be recorded by FSIS and used for internal Agency analysis and quarterly aggregate reports.

Establishments that wish to perform Campylobacter testing to verify their process control procedures can use the FSIS MLG method. Alternatively, establishments may rely on methods that have been validated to provide equivalent or superior sensitivity. For example, verification testing programs based solely on enriching samples could provide equivalent sensitivity compared with the FSIS method. To be comparable with the FSIS method, confirmatory methods should be demonstrated to be capable of detecting C. coli, C. jejuni, and C. lari. However, FSIS realizes that C. lari is rarely encountered in poultry samples. The culture and identification procedures in MLG 41 are not optimized for detection of non- Campylobacter j/c/l species.

Questions related to specific Campylobacter methods used by establishments should be directed to the AskFSIS sampling queue at http://www.fsis.usda.gov/Businesses/index.asp.

One comment queried why available Polymerase Chain Reaction (PCR) methodology is not used by the Agency.

FSIS Response: For its baseline testing, FSIS applied standard culture methodology recommended by the NACMCF for detecting and quantifying levels of Campylobacter on poultry samples. Non-proprietary traditional culture methodology offers advantages for reliability of results, the potential for confirming and subtyping isolates, and implementation of testing in a broad range of laboratories that may not have access to equipment for PCR or similar testing technologies. FSIS plans to apply the same NACMCF-recommended methodology used in the baseline study for future Agency verification testing. However, FSIS is encouraging development and validation of alternative testing methodologies for detecting and quantifying Campylobacter.

One comment questioned the Agency use of different sampling methodologies for young chickens and turkeys, asserting that the turkey methodology is biased against finding Salmonella and Campylobacter.

FSIS Response: FSIS agrees that sampling methodology has an impact on pathogen detection and enumeration. Because different sampling methodologies are used for chicken and turkey carcasses, FSIS has not proposed to compare data for these commodities. FSIS agrees that rinsate sampling, even without complete recovery of attached pathogens, provides a representative sample for internal and external carcass surfaces. For the first turkey carcass baseline in the mid-1990s, FSIS had attempted to use 600 mL rinsate sampling for turkey carcasses. However, because the typical turkey carcass was quite large and heavy, the manual rinse procedure posed problems for effective sampling and workplace safety. Following that initial study, FSIS adopted an industry recommendation to use a sponge to sample a 100 cm 2 area of the turkey carcass. To compare the effectiveness of rinse vs. sponge sampling, FSIS conducted two baseline studies, Young Turkey Rinse Baseline (1996-1997) and the Young Turkey Sponge Baseline (1997-1998). The two baseline studies demonstrated a comparable Salmonella prevalence of 18.6 percent and 19.6 percent, respectively. For the most recent turkey carcass baseline study in 2009, FSIS considered sampling skin from the neck flap or other areas of the carcass, but these sampling procedures also present technical and logistical challenges. FSIS agrees that sponge sampling likely under-represents the prevalence and levels of Salmonella and Campylobacter on turkey carcasses, but this approach, applied consistently over time to sampling continues to provide an effective means to identify establishments where process control may be less robust.

General questions were raised about Agency policies regarding Campylobacter following implementation of the new performance standards.

FSIS Response: The Agency will respond to a sample set failure for either organism by immediately scheduling a follow-up set, the samples of which will be analyzed for both organisms. An FSA will automatically be triggered under the current criteria for failing the Salmonella standard. The Agency will follow the Salmonella methodology for Campylobacter until FSIS develops specific methodology for a Campylobacter FSA. The Agency will not set an automatic Campylobacter FSA trigger until two full sample sets have been completed under the new standard for 90 percent of the eligible establishments in the product class, at which time the Agency will evaluate the results to determine the best food safety and public health policy. The Agency may, however, conduct an FSA for any establishment failing the Campylobacter performance standard for two sets straight or in the case of egregious failure of a single set. The concept for an egregious failure is based on a comparison of the establishment's performance for the set versus establishments' performances on other sets during some specified period of time. Thus, the actual criterion for determining an egregious failure could, and is expected to, change over time. The criterion is based on first determining an 80th percentile of the distribution of establishment-specific prevalences of positive results over some specified period, and then determining a cutoff threshold for the number of positive results in a set such that if exceeded for a set would be considered an egregious occurrence. Using the Young Chicken Baseline Survey and a statistical model using empirical Bayes estimation procedures for developing a tentative criterion, the Agency estimated the 80th percentile of the establishments' specific estimated prevalence to be 18 percent. The compliance criterion would therefore be 14 positive samples out of a 51 sample set. Fifteen or more positive results would be considered egregious given there would be more than 95 percent confidence that the true underlying establishment-specific prevalence during the period of sampling exceeded 18 percent, based on an assumption that positive results are distributed randomly following the binomial distribution. However, as mentioned above, FSIS expects this threshold value to change over time as data from the HACCP verification samples are analyzed.

Public awareness of all segments of rulemaking and policy development is important. Consequently, in an effort to ensure that minorities, women, and persons with disabilities are aware of this notice, FSIS will announce it online through the FSIS Web page located at http://www.fsis.usda.gov/regulations_&_policies/Federal_Register_Notices/index.asp.

FSIS will also make copies of this Federal Register publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, and other types of information that could affect or would be of interest to constituents and stakeholders. The Update is communicated via Listserv, a free electronic mail subscription service for industry, trade groups, consumer interest groups, health professionals, and other individuals who have asked to be included. The Update is also available on the FSIS Web page. Through the Listserv and Web page, FSIS is able to provide information to a much broader and more diverse audience. In addition, FSIS offers an electronic mail subscription service which provides automatic and customized access to selected food safety news and information. This service is available at http://www.fsis.usda.gov/news_&_events/e-mail_subscription/ . Options range from recalls to export information to regulations, directives and notices. Customers can add or delete subscriptions themselves, and have the option to password protect their accounts.

Agenda topics include solicitation for new RAC project proposals, reviewing progress on current projects, and receiving public comment. If the meeting location is changed, notice will be posted in the local newspapers, including the Clark Fork Valley Press, and Sanders County Ledger.

The meeting is open to the public. The following business will be conducted: (1) Introductions of all committee members, replacement members and Forest Service personnel; (2) Review status of approved projects; (3) Review, evaluate and recommend project proposals to be funded with Title II money; (4) Create a timeline to receive and review new project proposals and schedule the next meeting; and (5) Public Comment. Persons who wish to bring related matters to the attention of the Committee may file written statements with the Committee staff before or after the meeting.

On September 14, 2010, the Department published the Preliminary Results. In the Preliminary Results, the Department determined that Union and Dongbu made sales of subject merchandise at less than NV during the POR, and that HYSCO and POSCO did not. In addition, based on the preliminary results for the respondents selected for individual review, the Department calculated a weighted-average margin for those companies that were not selected for individual review.

We conducted sales verifications at the POSCO Group from October 18 through 22, 2010, at HYSCO from October 25 through 29, 2010, and at Union from November 1 through 5, 2010. We conducted cost verifications at HYSCO from October 4 through 8, 2010, at the POSCO Group from October 11 through 15, 2010, and at Union from November 8 through 12, 2010. On December 7, 15, and 21, 2010, respectively, the Department released sales verification reports for Union, HYSCO, and the POSCO Group. On November 29, December 6, and December 17, 2010, respectively, the Department released cost verification reports for the POSCO Group, HYSCO, and Union.

On December 13, 2010, the Department extended the time limits for the final results of this review until no later than March 14, 2011. See Corrosion-Resistant Carbon Steel Flat Products From the Republic of Korea: Notice of Extension of Time Limit for the Final Results of Antidumping Duty Administrative Review, 75 FR 77615 (December 13, 2010).

We invited parties to comment on our Preliminary Results. On January 14, 2011, United States Steel Corporation (U.S. Steel) filed case briefs concerning all four mandatory respondents. On January 14, 2011, HYSCO, POSCO, Union, and Dongbu each filed case briefs. On January 14, 2011, Hausys submitted its case brief, stating that it supports the arguments submitted by Union and Dongbu in their case briefs because Hausys's dumping margin would be based on the respondents subject to individual examination. On January 21, 2011, U.S. Steel and Nucor Corporation (Nucor) (collectively, petitioners) each filed rebuttal briefs. On January 21, 2011, HYSCO, POSCO, Union, and Dongbu each filed rebuttal briefs.

This order covers cold-rolled (cold-reduced) carbon steel flat-rolled carbon steel products, of rectangular shape, either clad, plated, or coated with corrosion-resistant metals such as zinc, aluminum, or zinc-, aluminum-, nickel- or iron-based alloys, whether or not corrugated or painted, varnished or coated with plastics or other nonmetallic substances in addition to the metallic coating, in coils (whether or not in successively superimposed layers) and of a width of 0.5 inch or greater, or in straight lengths which, if of a thickness less than 4.75 millimeters, are of a width of 0.5 inch or greater and which measures at least 10 times the thickness or if of a thickness of 4.75 millimeters or more are of a width which exceeds 150 millimeters and measures at least twice the thickness, as currently classifiable in the Harmonized Tariff Schedule of the United States (HTSUS) under item numbers 7210.30.0030, 7210.30.0060, 7210.41.0000, 7210.49.0030, 7210.49.0090, 7210.61.0000, 7210.69.0000, 7210.70.6030, 7210.70.6060, 7210.70.6090, 7210.90.1000, 7210.90.6000, 7210.90.9000, 7212.20.0000, 7212.30.1030, 7212.30.1090, 7212.30.3000, 7212.30.5000, 7212.40.1000, 7212.40.5000, 7212.50.0000, 7212.60.0000, 7215.90.1000, 7215.90.3000, 7215.90.5000, 7217.20.1500, 7217.30.1530, 7217.30.1560, 7217.90.1000, 7217.90.5030, 7217.90.5060, 7217.90.5090. Included in this order are corrosion-resistant flat-rolled products of non-rectangular cross-section where such cross-section is achieved subsequent to the rolling process ( i.e., products which have been “worked after rolling”)—for example, products which have been beveled or rounded at the edges. Excluded from this order are flat-rolled steel products either plated or coated with tin, lead, chromium, chromium oxides, both tin and lead (terne plate), or both chromium and chromium oxides (tin-free steel), whether or not painted, varnished or coated with plastics or other nonmetallic substances in addition to the metallic coating. Also excluded from this order are clad products in straight lengths of 0.1875 inch or more in composite thickness and of a width which exceeds 150 millimeters and measures at least twice the thickness. Also excluded from this order are certain clad stainless flat-rolled products, which are three-layered corrosion-resistant carbon steel flat-rolled products less than 4.75 millimeters in composite thickness that consist of a carbon steel flat-rolled product clad on both sides with stainless steel in a 20%-60%-20% ratio.

These HTSUS item numbers are provided for convenience and customs purposes. The written descriptions remain dispositive.

All issues raised in the case and rebuttal briefs by parties to this administrative review are addressed in the accompanying Issues and Decision Memorandum, which is hereby adopted by this notice. A list of the issues which parties have raised, and to which we have responded in the Issues and Decision Memorandum, is attached to this notice as an Appendix. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly on the Internet at http://ia.ita.doc.gov/frn. The paper copy and electronic version of the Issues and Decision Memorandum are identical in content.

As a result of the Department's analysis of comments received, we have made certain changes to the calculations of company-specific weight-average margins.

For Union, we revised our treatment of laminated CORE products as noted at Comment 2 of our Issues and Decision Memorandum. See also “Calculation Memorandum for Union Steel,” from Dennis McClure to the File, dated March 14, 2011. We have also revised Union's reported cost of manufacturing figures to reflect a recalculation of Union's scrap offset, GNA-expense rate calculation, cost of goods sold denominator to reflect the FY scrap revenue, and financial expense ratio as noted at Comments 16, 17, 18, and 19. See also “Cost of Production and Constructed Value Calculation Adjustments for the Final Results—Union Steel Co. Ltd.,” from Kristin Case to Neal Halper, dated March 14, 2010.

For the POSCO Group, we revised our treatment of laminated CORE products, U.S. warranty expenses, home market indirect selling expenses, and U.S. indirect selling expenses incurred in the country of manufacture, as noted at Comments 2, 6, and 9 of our Issues and Decision Memorandum. See also “Calculation Memorandum for Pohang Iron & Steel Company, Ltd. (POSCO), and Pohang Coated Steel Co., Ltd. (POCOS) (collectively, the POSCO Group),” from Victoria Cho to the File, dated March 14, 2011. We have also revised the POSCO Group's reported cost of manufacturing figures to reflect a recalculation of POSCO's total cost of manufacturing, as noted at Comment 12. See also “Cost of Production and Constructed Value Calculation Adjustments for the Final Results—Pohang Iron & Steel Company, Ltd., and Pohang Coated Steel Co., Ltd.,” from Sheikh M. Hannan to Neal M. Halper, dated March 14, 2011.

For HYSCO, we calculated the temper rolling cost adjustment factors for both temper rolled and non-temper rolled products and applied them to HYSCO's reported cost file as noted at Comment 5 of our Issues and Decision Memorandum. See also “Cost of Production and Constructed Value Calculation Adjustments for the Final Results—Hyundai HYSCO,” from Ji Young Oh to Neal M. Halper, dated March 14, 2011 ( HYSCO's Final Cost Calculation Memorandum ). Moreover, we reversed our adjustment made in the Preliminary Results as facts available, regarding the use of weighted-average value of SOTHMAT, DIRLAB, and FOH from the cost file for CONNUMS with negative values and disregarded the cost file field COMADJ3 as noted at Comment 4 of our Issues and Decision Memorandum. See Preliminary Results, 75 FR at 55774; see also HYSCO's Final Cost Calculation Memorandum.

We have made no changes to Dongbu's margin calculations since the Preliminary Results. See “Final Results in the 16th Administrative Review on Corrosion-Resistant Carbon Steel Flat Products from Korea: Calculation Memorandum for Dongbu Steel,” from Christopher Hargett to the File, dated March 14, 2011.

We determine that the following weighted-average margins exist:

The Department will determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries, pursuant to 19 CFR 351.212(b). The Department calculated importer-specific duty assessment rates on the basis of the ratio of the total antidumping duties calculated for the examined sales to the total entered value of the examined sales for that importer. Where the assessment rate is above de minimis, we will instruct CBP to assess duties on all entries of subject merchandise by that importer. The Department intends to issue appropriate assessment instructions directly to CBP 15 days after publication of these final results of review.

The Department clarified its “automatic assessment” regulation on May 6, 2003 (68 FR 23954). This clarification applies to POR entries of subject merchandise produced by companies examined in this review ( i.e., companies for which a dumping margin was calculated) where the companies did not know that their merchandise was destined for the United States. In such instances, we will instruct CBP to liquidate unreviewed entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction. For a full discussion of this clarification, see Antidumping and Countervailing Duty Proceedings: Assessment of Antidumping Duties, 68 FR 23954 (May 6, 2003).

The following deposit requirements will be effective upon publication of the final results of this administrative review for all shipments of CORE from Korea entered, or withdrawn from warehouse, for consumption on or after the publication date of these final results, as provided by section 751(a) of the Tariff Act of 1930, as amended (the Act): (1) For companies covered by this review, the cash deposit rate will be the rate listed above; (2) for previously reviewed or investigated companies other than those covered by this review, the cash deposit rate will be the company-specific rate established for the most recent period; (3) if the exporter is not a firm covered in this review, a prior review, or the less-than-fair-value investigation, but the producer is, the cash deposit rate will be the rate established for the most recent period for the manufacturer of the subject merchandise; and (4) if neither the exporter nor the producer is a firm covered in this review, a prior review, or the investigation, the cash deposit rate will be 17.70 percent, the all-others rate established in the less-than-fair-value investigation. These deposit requirements shall remain in effect until further notice.

This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping and/or countervailing duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the presumption that reimbursement of antidumping and/or countervailing duties occurred and the subsequent increase in antidumping duties by the amount of antidumping and/or countervailing duties reimbursed.

This notice also is the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305. Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.

We are issuing and publishing these results and notice in accordance with sections 751(a)(1) and 777(i)(1) of the Act.

Title III of the Export Trading Company Act of 1982 (15 U.S.C. 4001-21) authorizes the Secretary of Commerce to issue Export Trade Certificates of Review. The regulations implementing Title III are found at 15 CFR part 325 (2010). The U.S. Department of Commerce, International Trade Administration, Office of Competition and Economic Analysis (“OCEA”) is issuing this notice pursuant to 15 CFR 325.6(b), which requires the Secretary of Commerce to publish a summary of the issuance in the Federal Register . Under Section 305(a) of the Export Trading Company Act (15 U.S.C. 4012(b)(1)) and 15 CFR 325.11(a), any person aggrieved by the Secretary's determination may, within 30 days of the date of this notice, bring an action in any appropriate district court of the United States to set aside the determination on the ground that the determination is erroneous.

ARC is certified to engage in the Export Trade Activities and Methods of Operation described below in the following Export Trade and Export Markets.

1. Products: All products.

2. Services: All services.

3. Technology Rights: Technology rights that relate to Products and Services including, but not limited to, patents, trademarks, copyrights, and trade secrets.

4. Export Trade Facilitation Services (as They Relate to the Export of Products, Services, and Technology Rights): Export Trade Facilitation Services include professional services in the areas of government relations and assistance with State and Federal programs; foreign trade and business protocol; consulting; market research and analysis; collection of information on trade opportunities; marketing; negotiations; joint ventures; shipping; export management; export licensing; advertising; documentation and services related to compliance with customs requirements; insurance and financing; trade show exhibitions; organizational development; management and labor strategies; licensing of technology; transportation; and facilitating the formation of products and services associations.

The Export markets include all parts of the world except the United States: (the fifty States of the United States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, American Samoa, Guam, the Commonwealth of the Northern Mariana Islands, and the Trust Territory of the Pacific Islands).

1. With respect to the export of Products and Services, licensing of Technology Rights and provision of Export Trade Facilitation Services, ARC may, subject to the terms and conditions listed below:

a. Provide and/or arrange for the provision of Export Trade Facilitation Services;

b. Engage in promotional and marketing activities and collect information on trade opportunities in the Export Markets and distribute such information to clients;

c. Enter into exclusive and/or non-exclusive licensing and/or sales agreements with Suppliers for the export of products and services, and/or technology rights to Export Markets;

d. Enter into exclusive and/or non-exclusive agreements with distributors and/or sales representatives in Export Markets;

e. Allocate export sales or divide Export Markets among Suppliers for the sale and/or licensing of products and services and/or technology rights;

f. Allocate export orders among Suppliers;

g. Establish the price of products and services and/or technology rights for sales and/or licensing in Export Markets; and

h. Negotiate, enter into, and/or manage licensing agreements for the export of technology rights.

2. ARC may exchange information with individual Suppliers on a one-to-one basis regarding that Supplier's inventories and near-term production schedules in order that the availability of Products for export can be determined and effectively coordinated by ARC with its distributors in Export Markets.

1. In engaging in Export Trade Activities and Methods of Operation, ARC will not intentionally disclose, directly or indirectly, to any Supplier any information about any other Supplier's costs, production, capacity, inventories, domestic prices, domestic sales, or U.S. business plans, strategies, or methods that is not already generally available to the trade or public.

2. ARC will comply with requests made by the Secretary of Commerce on behalf of the Secretary or the Attorney General for information or documents relevant to conduct under the Certificate. The Secretary of Commerce will request such information or documents when either the Attorney General or the Secretary of Commerce believes that the information or documents are required to determine that the Export Trade, Export Trade Activities and Methods of Operation of a person protected by this Certificate of Review continue to comply with the standards of section 303(a) of the Act.

“Supplier” means a person who produces, provides, or sells Products, Services, and/or Technology Rights.

On September 14, 2010, the Department published the preliminary results of this administrative review. See AR4 Preliminary Results. The merchandise covered by the order is floor-standing, metal-top ironing tables and certain parts thereof from the PRC, as described in the “Scope of the Order” section of this notice. The period of review (POR) is August 1, 2007, through July 31, 2008. This administrative review covers Since Hardware.

In the Preliminary Results, we invited parties to comment. Additionally, on October 22, 2010 we issued to Interested Parties a Memorandum detailing the Industry Specific Wage Rates that the Department has used in these Final Results. See October 22, 2010, Memorandum from Michael J. Heaney to the File: “08/01/2007-07/31/2008 Review of the Antidumping Duty Order on Floor Standing Metal Top Ironing Tables from the People's Republic of China: Industry Specific Wage Rate Selection.” We invited interested parties to comment on the Department's calculation of industry specific wage rates that are outlined in our October 22, 2010, Industry Specific Wage Rate Memorandum. On November 3, 2010, we extended the due date for filing case briefs until November 15, 2010. In response, on November 15, 2010, the Department received a case brief from Home Products International (the Petitioner in this case). 1 Petitioner, and Since Hardware submitted rebuttal briefs on November 22, 2010. On December 27, 2010, the Department extended the time frame for the final results of review by an additional 60 days. See Floor-Standing Metal-Top Ironing Tables and Certain Parts Thereof from the People's Republic of China: Extension of Time Limit for the Final Results of Administrative Review, 75 FR 81212 (December 27, 2010).

For purposes of the order, the product covered consists of floor-standing, metal-top ironing tables, assembled or unassembled, complete or incomplete, and certain parts thereof. The subject tables are designed and used principally for the hand ironing or pressing of garments or other articles of fabric. The subject tables have full-height leg assemblies that support the ironing surface at an appropriate (often adjustable) height above the floor. The subject tables are produced in a variety of leg finishes, such as painted, plated, or matte, and they are available with various features, including iron rests, linen racks, and others. The subject ironing tables may be sold with or without a pad and/or cover. All types and configurations of floor-standing, metal-top ironing tables are covered by this review.

Furthermore, the order specifically covers imports of ironing tables, assembled or unassembled, complete or incomplete, and certain parts thereof. For purposes of the order, the term “unassembled” ironing table means a product requiring the attachment of the leg assembly to the top or the attachment of an included feature such as an iron rest or linen rack. The term “complete” ironing table means product sold as a ready-to-use ensemble consisting of the metal-top table and a pad and cover, with or without additional features, e.g., iron rest or linen rack. The term “incomplete” ironing table means product shipped or sold as a “bare board”— i.e., a metal-top table only, without the pad and cover—with or without additional features, e.g. iron rest or linen rack. The major parts or components of ironing tables that are intended to be covered by the order under the term “certain parts thereof” consist of the metal top component (with or without assembled supports and slides) and/or the leg components, whether or not attached together as a leg assembly. The order covers separately shipped metal top components and leg components, without regard to whether the respective quantities would yield an exact quantity of assembled ironing tables.

Ironing tables without legs (such as models that mount on walls or over doors) are not floor-standing and are specifically excluded. Additionally, tabletop or countertop models with short legs that do not exceed 12 inches in length (and which may or may not collapse or retract) are specifically excluded.

The subject ironing tables were previously classified under Harmonized Tariff Schedule of the United States (HTSUS) subheading 9403.20.0010. Effective July 1, 2003, the subject ironing tables are classified under new HTSUS subheading 9403.20.0011. The subject metal top and leg components are classified under HTSUS subheading 9403.90.8040. Although the HTSUS subheadings are provided for convenience and for Customs and Border Protection (CBP) purposes, the Department's written description of the scope remains dispositive.

Since Hardware requested a separate, company-specific antidumping duty rate. In the AR4 Preliminary Results, we found that Since Hardware had met the criteria for the application of a separate antidumping duty rate. See Preliminary Results, 75 FR at 55761.

We verified the separate rate information submitted by Since Hardware. See August 23, 2010 Verification of the Sales and Factors Response of Since Hardware (Guangzhou) Co., Ltd. in the Antidumping Review of Floor Standing Metal Top Ironing Tables (Ironing Tables) and Certain Parts Thereof from the People's Republic of China (PRC) (Since Hardware Verification Report) at 6.

Moreover, we have not received any information since the Preliminary Results with respect to Since Hardware that would warrant reconsideration of our separate-rates determination. Therefore, we have assigned an individual dumping margin to Since Hardware for this review period.

All issues raised in the case briefs by the parties and to which we have responded are addressed in the Memorandum to Ronald K. Lorentzen, Deputy Assistant Secretary for Import Administration, from Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, entitled “Issues and Decision Memorandum for the Final Results in the Administrative Review of Floor-Standing, Metal-Top Ironing Tables and Certain Parts Thereof from the People's Republic of China”, (March 14, 2011) (Issues and Decision Memorandum), which is hereby adopted by this notice. A list of the issues raised, all of which are in the Issues and Decision Memorandum, is attached to this notice as Appendix I. Parties can find a complete discussion of all issues raised in the briefs and the corresponding recommendations in this public memorandum, which is on file in the Central Records Unit (CRU), room 7046 of the Department of Commerce. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly on the Web at http://trade.gov/ia. The paper copy and electronic version of the Issues and Decision Memorandum are identical in content.

Based on the comments received from interested parties, we have made the following changes from that presented in our Preliminary Results:

We have based our calculations of labor inputs on industry specific wage rates.

We have applied brokerage and handling charges according to the weight of the merchandise and the container size of the shipment.

We have corrected an error in our calculation of the surrogate value of water.

We determine that the following antidumping duty margins exist in these final results:

For details on the calculation of the antidumping duty weighted-average margin for Since Hardware, see Memorandum to the File from Michael J. Heaney, Senior International Trade Compliance Analyst; “Floor-Standing, Metal-Top Ironing Tables and Certain Parts Thereof from the People's Republic of China: dated March 14, 2011. The public version of this memorandum is on file in the CRU.

Pursuant to section 751(a)(2)(A) of the Tariff Act of 1930, as amended (the Act) and 19 CFR 351.212(b), the Department will determine, and CBP shall assess, antidumping duties on all appropriate entries. The Department intends to issue assessment instructions to CBP 15 days after the date of publication of these final results of review. For assessment purposes, where possible, we calculated importer-specific assessment rates for subject ironing tables from the PRC via ad valorem duty assessment rates based on the ratio of the total amount of the dumping margins calculated for the examined sales to the total entered value of those same sales. We will instruct CBP to assess antidumping duties on all appropriate entries covered by this review.

This notice also serves as the final reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and in the subsequent assessment of double antidumping duties.

This notice also serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction or conversion to judicial protective order of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.

This administrative review and this notice are published in accordance with sections 751(a)(1) and 777(i)(1) of the Act.

On September 14, 2010, the Department published the preliminary results of this administrative review. See AR5 Preliminary Results. The merchandise covered by the order is floor-standing, metal-top ironing tables and certain parts thereof from the PRC, as described in the “Scope of the Order” section of the this notice. The period of review (POR) is August 1, 2008, through July 31, 2009. This administrative review covers Foshan Shunde and Since Hardware.

In the Preliminary Results, we invited parties to comment. Additionally, on October 22, 2010 we issued to interested parties a memorandum detailing the industry-specific wage rates that the Department intended to use in these Final Results. See October 22, 2010, Memorandum from Michael J. Heaney to the File: “08/01/2008/07/31/2009 Review of the Antidumping Duty Order on Floor Standing Metal Top Ironing Tables from the People's Republic of China: Industry Specific Wage Rate Selection.” We invited interested parties to comment on the Department's calculation of industry specific wage rates that are outlined in our October 22, 2010, Industry Specific Wage Rate Memorandum. On November 3, 2010, we extended the due date for filing case briefs until November 15, 2010. In response, on November 15, 2010, the Department received respective case briefs from Foshan Shunde and from Home Products International (the Petitioner in this case). 1 Petitioner, Foshan Shunde, and Since Hardware submitted rebuttal briefs on November 22, 2010. On December 27, 2010, the Department extended the time frame for the final results of review by an additional 60 days. See Floor-Standing Metal-Top Ironing Tables and Certain Parts Thereof from the People's Republic of China: Extension of Time Limit for the Final Results of Administrative Review, 75 FR 81212 (December 27, 2010).

For purposes of the order, the product covered consists of floor-standing, metal-top ironing tables, assembled or unassembled, complete or incomplete, and certain parts thereof. The subject tables are designed and used principally for the hand ironing or pressing of garments or other articles of fabric. The subject tables have full-height leg assemblies that support the ironing surface at an appropriate (often adjustable) height above the floor. The subject tables are produced in a variety of leg finishes, such as painted, plated, or matte, and they are available with various features, including iron rests, linen racks, and others. The subject ironing tables may be sold with or without a pad and/or cover. All types and configurations of floor-standing, metal-top ironing tables are covered by this review.

Furthermore, the order specifically covers imports of ironing tables, assembled or unassembled, complete or incomplete, and certain parts thereof. For purposes of the order, the term “unassembled” ironing table means a product requiring the attachment of the leg assembly to the top or the attachment of an included feature such as an iron rest or linen rack. The term “complete” ironing table means product sold as a ready-to-use ensemble consisting of the metal-top table and a pad and cover, with or without additional features, e.g., iron rest or linen rack. The term “incomplete” ironing table means product shipped or sold as a “bare board”— i.e., a metal-top table only, without the pad and cover—with or without additional features, e.g. iron rest or linen rack. The major parts or components of ironing tables that are intended to be covered by the order under the term “certain parts thereof” consist of the metal top component (with or without assembled supports and slides) and/or the leg components, whether or not attached together as a leg assembly. The order covers separately shipped metal top components and leg components, without regard to whether the respective quantities would yield an exact quantity of assembled ironing tables.

Ironing tables without legs (such as models that mount on walls or over doors) are not floor-standing and are specifically excluded. Additionally, tabletop or countertop models with short legs that do not exceed 12 inches in length (and which may or may not collapse or retract) are specifically excluded.

The subject ironing tables were previously classified under Harmonized Tariff Schedule of the United States (HTSUS) subheading 9403.20.0010. Effective July 1, 2003, the subject ironing tables are classified under new HTSUS subheading 9403.20.0011. The subject metal top and leg components are classified under HTSUS subheading 9403.90.8040. Although the HTSUS subheadings are provided for convenience and for Customs and Border Protection (CBP) purposes, the Department's written description of the scope remains dispositive.

Foshan Shunde and Since Hardware requested a separate, company-specific antidumping duty rate. In the AR5 Preliminary Results, we found that both Foshan Shunde and Since Hardware had met the criteria for the application of a separate antidumping duty rate. See Preliminary Results, 75 FR at 55755-55756. We verified Foshan Sunde's and Since Hardware's separate rate responses and found no discrepancies.

Further, we have not received any information since the Preliminary Results with respect to Foshan Shunde or Since Hardware that would warrant reconsideration of our separate-rates determination. Therefore, we have assigned an individual dumping margin to Foshan Shunde and Since Hardware for this review period.

All issues raised in the case briefs by the parties and to which we have responded are addressed in the Memorandum to Ronald K. Lorentzen, Deputy Assistant Secretary for Import Administration, from Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, entitled “Issues and Decision Memorandum for the Final Results in the Administrative Review of Floor-Standing, Metal-Top Ironing Tables and Certain Parts Thereof from the People's Republic of China,” (March 14, 2011) (Issues and Decision Memorandum), which is hereby adopted by this notice. A list of the issues raised, all of which are in the Issues and Decision Memorandum, is attached to this notice as Appendix I. Parties can find a complete discussion of all issues raised in the briefs and the corresponding recommendations in this public memorandum, which is on file in the Central Records Unit (CRU), room 7046 of the Department of Commerce. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly on the Web at http://trade.gov/ia. The paper copy and electronic version of the Issues and Decision Memorandum are identical in content.

Based on the comments received from interested parties, we have made the following changes from that presented in our Preliminary Results:

For both Foshan Shunde and Since Hardware, we have based our calculations of labor inputs on industry-specific wage rates using the methodology set forth in our Industry Specific Wage Rate Memorandum.

For both Foshan Shunde and Since Hardware, we have revised our calculation of brokerage and handling and applied these charges according to the weight of the merchandise and the container size of the shipment.

For both Foshan Shunde and Since Hardware, we have corrected an error in our calculation of the surrogate value of water.

For Foshan Shunde we have revised the cotton conversion factor used in our calculations.

For Foshan Shunde, we have included the cost of cartons in our calculation of packing charges.

We determine that the following antidumping duty margins exist in these final results:

For details on the calculation of the antidumping duty weighted-average margin for Foshan Shunde and Since Hardware, see Memorandum to the File from Michael J. Heaney, Senior International Trade Compliance Analyst; “Floor-Standing, Metal-Top Ironing Tables and Certain Parts Thereof From the People's Republic of China: Foshan Shunde Yongjian Housewares & Hardware Co., (Foshan Shunde) Analysis Memorandum for the Final Results,” dated March 14 2011; see also Memorandum to the File from Michael J. Heaney, Senior International Trade Compliance Analyst; “Floor-Standing, Metal-Top Ironing Tables and Certain Parts Thereof from the People's Republic of China: Since Hardware (Guangzhou) Co., Ltd. (Since Hardware) Analysis Memorandum for the Final Results.” The public versions of both memoranda are on file in the CRU.

Pursuant to section 751(a)(2)(A) of the Tariff Act of 1930, as amended (the Act) and 19 CFR 351.212(b), the Department will determine, and CBP shall assess, antidumping duties on all appropriate entries. The Department intends to issue assessment instructions to CBP 15 days after the date of publication of these final results of review. For assessment purposes, where possible, we calculated importer-specific assessment rates for subject ironing tables from the PRC via ad valorem duty assessment rates based on the ratio of the total amount of the dumping margins calculated for the examined sales to the total entered value of those same sales. We will instruct CBP to assess antidumping duties on all appropriate entries covered by this review.

The following cash deposit requirements will be effective upon publication of these final results of this administrative review for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided for by section 751(a)(2)(C) of the Act: (1) For Foshan Shunde the cash deposit rate will be 18.76 percent; (2) for Since Hardware, the cash deposit rate will be 70. 05 percent; (3) for previously-investigated or reviewed PRC and non-PRC exporters not listed above that have separate rates, the cash deposit rate will continue to be the exporter-specific rate published for the most recent period; (4) for all PRC exporters of subject merchandise that have not been found to be entitled to a separate rate, the cash deposit rate will be the PRC-wide rate of 157.68 percent; and (5) for all non-PRC exporters of subject merchandise which have not received their own rate, the cash deposit rate will be the rate applicable to the PRC exporters that supplied that non-PRC exporter. These deposit requirements, when imposed, shall remain in effect until further notice.

This notice also serves as the final reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and in the subsequent assessment of double antidumping duties.

This notice also serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction or conversion to judicial protective order of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.

This administrative review and this notice are published in accordance with sections 751(a)(1) and 777(i)(1) of the Act.

On December 1, 2010, the Department of Commerce (the Department) published a notice of opportunity to request an administrative review of the countervailing duty (CVD) order on certain hot-rolled carbon steel flat products from India. See Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation; Opportunity To Request Administrative Review, 75 FR 74682 (December 1, 2010). On January 3, 2011, we received from United States Steel Corporation, a domestic producer of subject merchandise, a request that the Department conduct an administrative review of Ispat Industries Limited (Ispat), for the review period January 1, 2010, through December 31, 2010.

On January 28, 2011, the Department published the notice of initiation of the administrative review of the CVD order covering Ispat for the period January 1, 2010, through December 31, 2010. See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 76 FR 5137 (January 28, 2011). On February 4, 2011, Ispat notified the Department that it had no shipments of subject merchandise to the United States during the period of review (POR). 1

The products covered under this order are certain hot-rolled flat-rolled carbon steel flat products of a rectangular shape, of a width of 0.5 inch or greater, neither clad, plated, nor coated with metal and whether or not painted, varnished, or coated with plastics or other non-metallic substances, in coils (whether or not in successively superimposed layers), regardless of thickness, and in straight lengths, of a thickness of less than 4.75 mm and of a width measuring at least 10 times the thickness. Universal mill plate ( i.e., flat-rolled products rolled on four faces or in a closed box pass, of a width exceeding 150 mm, but not exceeding 1250 mm, and of a thickness of not less than 4 mm, not in coils and without patterns in relief) of a thickness not less than 4.0 mm is not included within the scope of this order.

Specifically included within the scope of this order are vacuum degassed, fully stabilized (commonly referred to as interstitial-free (IF)) steels, high strength low alloy (HSLA) steels, and the substrate for motor lamination steels. IF steels are recognized as low carbon steels with micro-alloying levels of elements such as titanium or niobium (also commonly referred to as columbium), or both, added to stabilize carbon and nitrogen elements. HSLA steels are recognized as steels with micro-alloying levels of elements such as chromium, copper, niobium, vanadium, and molybdenum. The substrate for motor lamination steels contains micro-alloying levels of elements such as silicon and aluminum.

Steel products to be included in the scope of this order, regardless of definitions in the Harmonized Tariff Schedule of the United States (HTSUS), are products in which: (i) Iron predominates, by weight, over each of the other contained elements; (ii) the carbon content is 2 percent or less, by weight; and (iii) none of the elements listed below exceeds the quantity, by weight, respectively indicated:

1.80 percent of manganese, or

2.25 percent of silicon, or

1.00 percent of copper, or

0.50 percent of aluminum, or

1.25 percent of chromium, or

0.30 percent of cobalt, or

0.40 percent of lead, or

1.25 percent of nickel, or

0.30 percent of tungsten, or

0.10 percent of molybdenum, or

0.10 percent of niobium, or

0.15 percent of vanadium, or

0.15 percent of zirconium.

All products that meet the physical and chemical description provided above are within the scope of this order unless otherwise excluded. The following products, by way of example, are outside or specifically excluded from the scope of this order:

• Alloy hot-rolled steel products in which at least one of the chemical elements exceeds those listed above (including, e.g., ASTM specifications A543, A387, A514, A517, A506).

• SAE/AISI grades of series 2300 and higher.

• Ball bearings steels, as defined in the HTUS.

• Tool steels, as defined in the HTUS.

• Silico-manganese (as defined in the HTUS) or silicon electrical steel with a silicon level exceeding 2.25 percent.

• ASTM specifications A710 and A736.

• USS Abrasion-resistant steels (USS AR 400, USS AR 500).

• All products (proprietary or otherwise) based on an alloy ASTM specification (sample specifications: ASTM A506, A507).

• Non-rectangular shapes, not in coils, which are the result of having been processed by cutting or stamping and which have assumed the character of articles or products classified outside chapter 72 of the HTUS.

The merchandise subject to this order are classified in the HTUS at subheadings: 7208.10.15.00, 7208.10.30.00, 7208.10.60.00, 7208.25.30.00, 7208.25.60.00, 7208.26.00.30, 7208.26.00.60, 7208.27.00.30, 7208.27.00.60, 7208.36.00.30, 7208.36.00.60, 7208.37.00.30, 7208.37.00.60, 7208.38.00.15, 7208.38.00.30, 7208.38.00.90, 7208.39.00.15, 7208.39.00.30, 7208.39.00.90, 7208.40.60.30, 7208.40.60.60, 7208.53.00.00, 7208.54.00.00, 7208.90.00.00, 7211.14.00.90, 7211.19.15.00, 7211.19.20.00, 7211.19.30.00, 7211.19.45.00, 7211.19.60.00, 7211.19.75.30, 7211.19.75.60, and 7211.19.75.90. Certain hot-rolled flat-rolled carbon-quality steel covered by this order, including: vacuum degassed fully stabilized; high strength low alloy; and the substrate for motor lamination steel may also enter under the following tariff numbers: 7225.11.00.00, 7225.19.00.00, 7225.30.30.50, 7225.30.70.00, 7225.40.70.00, 7225.99.00.90, 7226.11.10.00, 7226.11.90.30, 7226.11.90.60, 7226.19.10.00, 7226.19.90.00, 7226.91.50.00, 7226.91.70.00, 7226.91.80.00, and 7226.99.00.00. Subject merchandise may also enter under 7210.70.30.00, 7210.90.90.00, 7211.14.00.30, 7212.40.10.00, 7212.40.50.00, and 7212.50.00.00. Although the HTUS subheadings are provided for convenience and U.S. Customs purposes, the Department's written description of the merchandise subject to this proceeding is dispositive.

Ispat submitted a letter to the Department on February 4, 2011, certifying that it had no shipments of subject merchandise to the United States during the POR. The petitioner did not comment on Ispat's claim of no shipments.

On February 7, 2011, we conducted an internal customs data query. 2 We also issued a “no shipments inquiry” message to U.S. Customs and Border Protection (CBP), which posted the message on February 16, 2011. 3 The customs data query indicates that Ispat had no entries of subject merchandise to the United States during the POR. We did not receive any information from CBP contrary to Ispat's claim of no shipments of subject merchandise to the United States during the POR.

Based on our analysis of the shipment data, we preliminarily determine that Ispat did not ship subject merchandise to the United States during the POR. Therefore, in accordance with 19 CFR 351.213(d)(3), and consistent with our practice, 4 we preliminarily determine to rescind the review for Ispat. Since Ispat was the only producer/exporter for which a review was requested and initiated, we also preliminarily determine to rescind the administrative review of the CVD order covering the period January 1, 2010, through December 31, 2010.

The Department is setting aside a period for interested parties to raise issues regarding the preliminary determination to rescind the administrative review for Ispat. The Department encourages all interested parties to submit such comments within 20 calendar days of the publication of this notice. Comments should be addressed to Import Administration's APO/Dockets Unit, Room 1870, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW., Washington, DC 20230. The period for public comment is intended to provide the Department with ample opportunity to consider all issues prior to the issuance of the notice to rescind the administrative review.

We are issuing this notice in accordance with sections 751(a)(1) and 777(i)(1) of the Tariff Act of 1930, as amended, and 19 CFR 351.213(d)(4) of the Department's regulations.

The subject permit is requested under the authority of the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq. ) and the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR 222-226).

The Virginia Living Museum [File No. 16266] is requesting a permit to continue enhancement activities previously authorized under Permit No. 1473. Activities would include the continued maintenance and educational display of eight captive-bred, non-releaseable adult shortnose sturgeon, as well as the transport of four shortnose sturgeon to the Maritime Aquarium at Norfolk. The Maritime Aquarium at Norwalk [File No. 16291] is requesting a permit to continue enhancement activities previously authorized under Permit No. 1472. Activities would include the acquisition of four captive- bred, non-releaseable adult shortnose sturgeon from the Virginia Living Museum for the maintenance and educational display of those specimens. Both displays would be used to increase public awareness of the shortnose sturgeon and its status by educating the public on shortnose sturgeon life history and the reasons for the species decline. The proposed projects to display endangered cultured shortnose sturgeon responds directly to a recommendation from the NMFS recovery plan outline for this species. The permits would not authorize any takes from the wild, nor would it authorize any release of captive sturgeon into the wild. The permits are requested for a duration of 5 years.

The following items are on the Pacific Council agenda, but not necessarily in this order:

Although non-emergency issues not contained in this agenda may come before this Council for discussion, those issues may not be the subject of formal Council action during this meeting. Council action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under Section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take final action to address the emergency.

Special Accommodations: These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Carolyn Porter at (503) 820-2280 at least 5 days prior to the meeting date.

Section 1605 of the Recovery Act requires that no appropriated funds may be used for the construction, alteration, maintenance, or repair of a public building or public work unless all of the iron, steel, and manufactured goods used in the project are produced in the United States, or unless a waiver is granted by the head of the Federal department or agency. A waiver may be granted if the head of the Federal department or agency determines that one of three exceptions applies: (1) The application of Section 1605 requirements would be inconsistent with the public interest; (2) the iron, steel, or relevant manufactured good is not produced in the United States in sufficient and reasonably available quantities and of satisfactory quality; or (3) the cost of domestic iron, steel or relevant manufactured goods will increase the cost of the overall project by more than 25 percent.

In accordance with Section 1605(c) of the Recovery Act, the Senior Center Contracting Official (SOCO) 772d ESS/PK has determined that the above items of manufactured goods are not produced in the United States in sufficient and reasonably available quantities and of a satisfactory quality.

The domestic nonavailability determination for these products is based on extensive market research and thorough investigation of the domestic manufacturing landscape. This research identified that these products are manufactured almost exclusively in China.

A Notice of Intent to prepare this Draft EIS was published in the Federal Register on May 15, 2009 (74 FR 22900). Three public scoping meetings were held in Poulsbo, Port Ludlow, and Seattle, WA. The first public scoping meeting was held on June 23, 2009, at the Poulsbo Fire Station Main Headquarters, 911 Northeast Liberty Road, Poulsbo, WA. The second public scoping meeting was held on June 24, 2009, at the Port Ludlow Fire Station 31, 7650 Oak Bay Road, Port Ludlow, WA. The third public scoping meeting was held on June 25, 2009, at the Starbucks Corporate Headquarters, 2401 Utah Avenue South, 3rd Floor, Seattle, WA. The meeting was originally scheduled to be held at the John Stanford Center for Educational Excellence, 2445 3rd Avenue South, Seattle, WA but was relocated due to unforeseen venue cancellation. Notifications were made to the media immediately upon reserving the new venue and handouts with the new location were distributed to those arriving at the John Stanford Center for Educational Excellence.

The proposed action is to construct and operate an EHW-2 adjacent to, but separate from, the existing Explosives Handling Wharf (EHW-1) at the NBK Bangor waterfront. The proposed action consists of in-water and land-based construction and operations. NBK Bangor, located on Hood Canal approximately 20 miles west of Seattle, provides berthing and support services for OHIO Class ballistic missile submarines, hereafter referred to as TRIDENT submarines. As part of the Navy's sea-based strategic deterrence mission, the Navy Strategic Systems Programs (SSP) directs research, development, manufacturing, test, evaluation, and operational support of the TRIDENT Fleet Ballistic Missile program. SSP is the action proponent and the Navy is the lead agency for this project.

The purpose for the proposed action is to support future TRIDENT program requirements for TRIDENT submarines currently homeported at NBK Bangor and the TRIDENT II (D5 missile) Strategic Weapons System. The proposed action is needed to support TRIDENT program requirements of 400 operational days per year. The EHW-1 currently provides approximately 200 operational days per year due to required facility preventative maintenance and pile replacement. The Navy anticipates that after pile replacement concludes in 2024, the EHW-1 will provide approximately 300 operational days per year. The proposed EHW-2 would provide 300 operational days per year. Therefore, EHW-1 and the proposed EHW-2 would provide a total available capacity of approximately 500-600 operational days per year. The proposed EHW-2 would be designed to meet all TRIDENT program requirements.

SSP evaluated a range of alternatives that would meet action objectives, and applied screening criteria to identify those alternatives that were “reasonable” ( i.e., practical and feasible). Screening criteria included: capability for meeting TRIDENT mission requirements; ability to avoid or minimize environmental impacts; siting requirements including proximity to existing infrastructure; availability of waterfront property; constructability of essential project features; and explosives safety restrictions. Reasonable alternatives were carried through the Draft EIS analysis.

The Draft EIS considers six alternatives including the No Action Alternative. Alternatives include in-water and land-based components such as the wharf, access trestles, an abutment where the trestles connect to the shore, extension of an existing paved road, construction of a new upland gravel access road, and an upland construction staging area. The wharf proper (excluding access trestles) would lie approximately 600 feet offshore at water depths of 60 feet to 100 feet, and would consist of a covered ordnance handling area, a warping wharf, and lightning protection towers. A warping wharf is a long narrow wharf extension used to position submarines prior to moving into the operations area of the EHW-2.

The six alternatives considered in this Draft EIS are as follows:

(1) Alternative 1 (Combined Trestle, Large Pile Wharf)—access trestles would be combined over shallow water to reduce impacts to shallow-water habitat and resources. The wharf would be supported primarily on large (up to 48-inch diameter) piles and smaller (24-inch to 36-inch diameter) piles. Alternative 1 is the preferred alternative.

(2) Alternative 2 (Combined Trestle, Conventional Pile Wharf)—access trestles would be combined as for Alternative 1 but would use a conventional pile wharf supported on a larger number of smaller piles (24-inch to 36-inch diameter). The dimensions of the conventional pile wharf would be the same as the large pile wharf. Pile driving would take longer than for Alternative 1.

(3) Alternative 3 (Separate Trestles, Large Pile Wharf)—access trestles would be completely separate. There would be more trestle piles and greater overwater area, including more area over shallow water. The large pile wharf would be the same as for Alternative 1.

(4) Alternative 4 (Separate Trestles, Conventional Pile Wharf)—access trestles would be separate as for Alternative 3 and would use a conventional pile wharf as for Alternative 2.

(5) Alternative 5 (Combined Trestle, Floating Wharf)—access trestles would be combined as for Alternatives 1 and 2. This alternative would employ a floating wharf rather than a pile-supported wharf. The wharf would be supported on large concrete pontoons and connected to mooring dolphins. The floating wharf would be larger than the pile-supported wharves and would entail considerably fewer piles than Alternatives 1 through 4.

(6) No Action Alternative—there would be no construction or operation of the EHW-2. The Navy would not have the required facilities to perform routine operations and upgrades required to maintain the current fleet of TRIDENT submarines at NBK Bangor through 2042, the life of the current TRIDENT weapons systems. The No Action Alternative is considered in accordance with Section 1502.14(d) of the NEPA regulation.

The Draft EIS evaluates the potential environmental effects associated with the construction and operation of the EHW-2 at NBK Bangor, WA. Alternatives were evaluated within several environmental resource areas including marine, upland, and social environments. These resource areas include: hydrography (currents and tides), water quality, sediment, underwater noise, marine vegetation, plankton, benthic communities including shellfish, marine fish, marine mammals, marine birds, threatened and endangered species, geology and soils, surface water and groundwater, vegetation, wetlands, wildlife, noise, air quality, cultural resources, American Indian traditional resources, coastal and shoreline management, land use and recreation, aesthetics, socioeconomics, utilities and energy, transportation, and public health and safety. Methods to reduce or minimize impacts to affected resources are addressed. The analysis includes an evaluation of the direct, indirect, and cumulative impacts.

All action alternatives would have the same types of environmental impacts; however, the magnitude of these impacts would vary among the alternatives. The principal types of marine impacts during project construction would include pile driving noise (and its effects on marine biota) and turbidity. In the long term, impacts would include loss and shading of marine habitat including eelgrass, macroalgae and benthic community, and interference with the migration of juvenile salmon, some species of which are protected under the Endangered Species Act (ESA). All action alternatives would have the potential to adversely affect fish and bird species protected under the ESA, and marine mammals (behavioral disturbance) protected under the ESA and the Marine Mammal Protection Act (MMPA). Injury is not expected to any marine mammal or bird. Upland construction would result in permanent and temporary impacts to forest, shrub lands, and wetlands; however, most areas would be replanted following construction and mitigation would offset the permanent loss of the wetland area. Wildlife would be disturbed by construction noise, especially pile driving, but no terrestrial animals or plants protected under the ESA, the Migratory Bird Treaty Act, or Bald and Golden Eagle Protection Act would be affected. Measures are proposed to mitigate these impacts. Recreational and residential areas would be disturbed by pile driving noise. Mitigation measures would be implemented to minimize impacts from pile driving noise. Construction barges could affect marine traffic in Hood Canal and would affect vehicle traffic on the Hood Canal Floating Bridge. Mitigation measures would be implemented to minimize impacts from marine construction traffic.

In accordance with Section 7 of the ESA, the Navy is consulting with NMFS and the U.S. Fish and Wildlife Service for potential impacts to Federally listed species. The Navy is also consulting with NMFS regarding potential effects on Essential Fish Habitat under the Magnuson Stevens Fishery Conservation and Management Act, and working with NMFS to ensure compliance with the MMPA. The Navy will submit an application to the USACE for a permit under Section 10 of the Rivers and Harbors Act, and Section 404 of the Clean Water Act. Navy analysis has indicated that under the Clean Air Act requirements, air pollutant emissions would not exceed thresholds for a major source for any alternative. Under all action alternatives, the setting of the EHW-1, which is eligible for listing under the National Register of Historic Places, would be adversely affected by the proposed action; however, the Navy will consult with the State Historic Preservation Officer (SHPO) and develop a mitigation plan. There would be a small potential for disturbance of archaeological resources during construction; if any such resources were encountered, the Navy would coordinate with the SHPO and affected American Indian Tribes. Access to Tribal fishing areas would not be affected by any alternative; however, implementation of the proposed action would adversely affect fish, which are Tribal treaty reserved resources. The Navy is conducting government-to-government consultation with the potentially affected Tribes. Mitigation is included as part of the proposed action to address the impacts to these aquatic resources.

The decision to be made by the Navy is to determine which of the alternatives analyzed in the EIS to implement, based upon reasonably foreseeable environmental impacts and operational needs.

The Draft EIS was distributed to Federal, State, and local agencies, elected officials, and other interested individuals and organizations. The public comment period will end on May 2, 2011. Copies of the Draft EIS are available for public review at the following libraries:

1. Jefferson County Rural Library, 620 Cedar Avenue, Port Hadlock, WA 98339;

2. Port Townsend Public Library, 1220 Lawrence Street, Port Townsend, WA 98368;

3. Poulsbo Library, 700 Northeast Lincoln Road, Poulsbo, WA 98370;

4. Silverdale Library, 3450 NW Carlton Street, Silverdale, WA 98383;

5. Sylvan Way Library, 1301 Sylvan Way, Bremerton, WA 98310; and

6. Seattle Central Library, 1000 Fourth Avenue, Seattle, WA 98104.

The TRIDENT Support Facilities EHW-2 Draft EIS is also available for electronic public viewing at: http://ehw.nbkeis.com . A paper copy of the executive summary or a single compact disc of the Draft EIS will be made available upon written request by contacting Naval Facilities Engineering Command Northwest, Attention: Ms. Christine Stevenson, EHW-2 EIS Project Manager, 1101 Tautog Circle, Silverdale, WA 98315-1101.

Federal, State, and local agencies, elected officials, and interested individuals and organizations are invited to be present or represented at the public hearings. Written comments can also be submitted during the open house sessions preceding the public hearings. Oral statements will be heard and transcribed by a court reporter; however, to ensure the accuracy of the record it is encouraged that all statements should also be submitted in writing. All statements, both oral and written, will become part of the public record on the Draft EIS and will be responded to in the Final EIS. Equal weight will be given to both oral and written statements. In the interest of available time, and to ensure all who wish to give an oral statement have the opportunity to do so, each speaker's comments will be limited to three (3) minutes. If a long statement is to be presented, it should be summarized at the public hearing with the full text submitted either in writing at the hearing or mailed to Naval Facilities Engineering Command Northwest, Attention: Ms. Christine Stevenson, EHW-2 EIS Project Manager, 1101 Tautog Circle, Silverdale, WA 98315-1101. Comments may also be submitted online at http://ehw.nbkeis.com/ during the comment period. All written comments must be postmarked by May 2, 2011, to ensure they become part of the official record. All comments will be addressed in the Final EIS.

Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that the Office of Management and Budget (OMB) provide interested Federal agencies and the public an early opportunity to comment on information collection requests. The OMB is particularly interested in comments which: (1) Evaluate 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; (2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (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, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

Type of Review: Extension.

Title of Collection: Application for Grants under the Historically Black Colleges and Universities and Historically Black Graduate Institutions Programs.

OMB Control Number: 1840-0113.

Agency Form Number(s): N/A.

Frequency of Responses: Annually.

Affected Public: Not-for-profit institutions; State, Local and Federal Governments.

Total Estimated Number of Annual Responses: 120.

Total Estimated Annual Burden Hours: 1,920.

Abstract: The collection of information is for the purpose of obtaining institutional and budgetary information needed to evaluate applications under the authority of Sections 321 and 326 of the Higher Education Act of 1965, as amended. The collection of information is gathered in two phases: Phase I—Formula Data and Phase II—The Project Plan. Both phases are submitted separately and individually by a select number of eligible institutions of higher education, as stipulated in the legislation.

This information collection is being submitted under the Streamlined Clearance Process for Discretionary Grant Information Collections (1894-0001). Therefore, the 30-day public comment period notice will be the only public comment notice published for this information collection.

Copies of the information collection submission for OMB review may be accessed from the RegInfo.gov Web site at http://www.reginfo.gov/public/do/PRAMain or from the Department's Web site at http://edicsweb.ed.gov, by selecting the “Browse Pending Collections” link and by clicking on link number 4525. When you access the information collection, click on “Download Attachments ” to view. Written requests for information should be addressed to U.S. Department of Education, 400 Maryland Avenue, SW., LBJ, Washington, DC 20202-4537. Requests may also be electronically mailed to the Internet address ICDocketMgr@ed.gov or faxed to 202-401-0920. Please specify the complete title of the information collection and OMB Control Number when making your request.

Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339.

Section 112(c)(3) and (k)(3)(B) of the Clean Air Act (CAA) requires that, by November 15, 2000, EPA promulgate emission standards to assure that area sources accounting for 90 percent of the aggregate area source emissions of each of the 30 urban hazardous air pollutants (HAP) are subject to regulation. 1 Similarly, section 112(c)(6) of the CAA requires that, by November 15, 2000, EPA promulgate emission standards to assure that sources accounting for not less than 90 percent of the aggregate emissions of each of the seven HAP enumerated in section 112(c)(6)are subject to standards. As a result of lawsuits filed by Sierra Club alleging that EPA has failed to complete these actions by the statutory deadline, EPA is under a court order to complete these obligations. Under the order, which was most recently amended on January 20, 2011, EPA must complete these obligations by February 21, 2011.

The following two technical memoranda document the actions the Agency has taken to meet these requirements, Topham to Docket, Emission Standards for Meeting the 90 Percent Requirement Under Section 112(c)(3) and Section 112(k)(3)(B) of the Clean Air Act (found in Docket ID EPA-HQ-OAR-2002-0036); and Topham to Docket, Emission Standards for Meeting the 90 Percent Requirement Under Section 112(c)(6) of the Clean Air Act (found in Docket ID EPA-HQ-OAR-2004-0505). These documents are available in the dockets for these actions. Based on my review of these two documents, I conclude that EPA has completed sufficient standards to meet the 90 percent requirement under both sections 112(c)(3) and(k)(3)(B), and section 112(c)(6).

Requests to make oral comments, or provide written comments to the Committees, should be sent to Oscar Carrillo, Designated Federal Officer, at the contact information above.

Meeting Access: For information on access or services for individuals with disabilities, please contact Oscar Carrillo at 202-564-0347 or carrillo.oscar@epa.gov. To request accommodation of a disability, please contact Oscar Carrillo, preferably at least 10 days prior to the meeting, to give EPA as much time as possible to process your request.

In accordance with the Privacy Act of 1974, as amended, the FDIC has conducted a review of its Privacy Act systems of records and has determined that it needs to add one new system of records to cover personal information submitted by residential mortgage loan originators and maintained in the Nationwide Mortgage Licensing System and Registry (NMLSR) pursuant to the S.A.F.E. Act. The new system of records is designated as FDIC-30-64-0032 (Nationwide Mortgage Licensing System and Registry).

The S.A.F.E. Act requires an employee of a bank, savings association, credit union or Farm Credit System institution and certain of their subsidiaries that are regulated by a Federal banking agency or the Farm Credit Administration who acts as a residential mortgage loan originator to register with the NMLSR, obtain a unique identifier, and maintain this registration. The NMLSR collects and stores information concerning a residential mortgage loan originator's identity including personal history and experience and may include information related to any administrative, civil, or criminal findings by any governmental jurisdiction. The information will be collected by entering information online into the NMLSR Web site. Once collected, the information will be maintained in the NMLSR electronic system in a secured environment.

The NMLSR is a Web-based system owned and operated by the State Regulatory Registry LLC (SRR). SRR is a limited-liability company established by Conference of State Bank Supervisors (CSBS) and the American Association of Residential Mortgage Regulators as a subsidiary of CSBS to develop and operate nationwide systems for State regulators in the financial services industry. SRR has contracted with the Financial Industry Regulatory Authority (FINRA) to build and maintain the NMLSR system. FINRA operates similar systems in the securities industry. More information about this system is available at http://mortgage.nationwidelicensingsystem.org/ .

Pursuant to section 6(f) of the Federal Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46(f), and § 2.34 the Commission Rules of Practice, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for March 15, 2010), on the World Wide Web, at http://www.ftc.gov/os/actions.shtm. A paper copy can be obtained from the FTC Public Reference Room, Room 130-H, 600 Pennsylvania Avenue, NW., Washington, DC 20580, either in person or by calling (202) 326-2222.

Public comments are invited, and may be filed with the Commission in either paper or electronic form. All comments should be filed as prescribed in the ADDRESSES section above, and must be received on or before the date specified in the DATES section.

The Federal Trade Commission (“FTC” or “Commission”) has accepted, subject to final approval, an agreement containing a consent order from Legacy Learning Systems, Inc. and Lester Gabriel Smith, an officer and director of the corporation (“respondents”).

The proposed consent order (“proposed order”) has been placed on the public record for thirty (30) days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After thirty (30) days, the Commission will again review the agreement and the comments received, and will decide whether it should withdraw from the agreement and take appropriate action or make final the agreement's proposed order.

The practices challenged in this case relate to the advertising of respondents' instructional courses via an online affiliate marketing program. According to the Commission's complaint, many of respondents' affiliates promoted respondents' instructional courses through positive endorsements in articles, blog posts, or other online editorial copy that contained hyperlinks to respondents' Web site in close proximity to the endorsements. For each sale of an instructional course to a consumer directed to respondents' Web site by an affiliate, respondents paid the affiliate a commission of 20 to 45 percent of the purchase price. The affiliates often posted endorsements about respondents' instructional courses using statements that gave readers the impression the endorsements had been submitted by ordinary consumers or independent reviewers. Respondents failed to implement a reasonable monitoring program to ensure that these postings clearly and prominently disclosed the compensated nature of the affiliates' relationship to respondents.

The Commission's complaint alleges that respondents violated Section 5 of the FTC Act by disseminating or causing to be disseminated reviews of their instructional courses that misrepresented that they were those of independent, ordinary consumers. The complaint further alleges that respondents violated Section 5 by failing to disclose, or disclose adequately, that the affiliates receive financial compensation from the sale of respondents' products.

Part I of the proposed order prohibits respondents, in connection with the advertising of any product or service, from misrepresenting the status of any user or endorser of a product or service, including, but not limited to, misrepresenting that the user or endorser is an independent user or ordinary consumer of the product or service.

Part II prohibits respondents from making any representation about any user or endorser of a product or service unless they disclose, clearly and prominently, a material connection, when one exists, between the user or endorser of the product or service and any other party involved in promoting that product or service. The proposed order defines “material connection” as any relationship that materially affects the weight or credibility of any endorsement and would not be reasonably expected by consumers.

Part III requires respondents to take immediate steps to ensure compliance with Parts I and II of the order, including maintaining a system to review and monitor their affiliate representations and disclosures. The proposed order requires respondents to determine, on a semi-annual basis, their top fifty (50) revenue-generating affiliates, and then monitor, on a monthly basis, the Web sites of those affiliates and the Web sites of a random sample of fifty (50) of their remaining affiliates. Part III also requires respondents to terminate any affiliate who engages in conduct inconsistent with Parts I and II of the order and to maintain reports regarding compliance with Part III of the order.

Part IV requires respondents to serve copies of the order to prospective affiliates prior to their entry into respondents' affiliate program, and to current affiliates within ten days of the date of service of the order.

Part V requires respondents to pay to the Commission a sum of $250,000. This payment may be used in the Commission's sole discretion to provide appropriate relief, which may include, but is not limited to, the recision of contracts, payment of damages, and/or public notification respecting the unfair or deceptive acts or practices alleged in the complaint. If the Commission determines that such relief is wholly or partially impracticable, any or all such funds shall be paid to the United States Treasury.

Parts VI through X of the proposed order require respondents to: Keep copies of relevant consumer complaints and inquiries, documents demonstrating order compliance, and any documents relating to any representation covered by this order; provide copies of the order to certain of their personnel; notify the Commission of changes in corporate structure that might affect compliance obligations under the order; notify the Commission of changes in corporate business or employment as to respondent Lester Gabriel Smith individually; and file compliance reports with the Commission. Part XI provides that the order will terminate after twenty (20) years, with certain exceptions.

The purpose of this analysis is to facilitate public comment on the proposed order, and it is not intended to constitute an official interpretation of the agreement and proposed order or to modify in any way their terms.

Pursuant to section 6(f) of the Federal Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46(f), and § 2.34 the Commission Rules of Practice, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for March 14, 2010), on the World Wide Web, at http://www.ftc.gov/os/actions.shtm. A paper copy can be obtained from the FTC Public Reference Room, Room 130-H, 600 Pennsylvania Avenue, NW., Washington, DC 20580, either in person or by calling (202) 326-2222.

Public comments are invited, and may be filed with the Commission in either paper or electronic form. All comments should be filed as prescribed in the ADDRESSES section above, and must be received on or before the date specified in the DATES section.

The Federal Trade Commission has accepted, subject to final approval, a consent agreement from Chitika, Inc. (“Chitika”).

The proposed consent order has been placed on the public record for thirty (30) days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After thirty (30) days, the Commission will again review the agreement and the comments received, and will decide whether it should withdraw from the agreement and take appropriate action or make final the agreement's proposed order.

Chitika is a network advertiser that engages in online behavioral advertising, the practice of tracking consumers' activities online in order to serve them targeted advertisements based upon their individual Web browsing activity. Chitika offers an online behavioral advertising service in which it acts as an intermediary between Web site publishers and advertisers that wish to have their advertisements placed on websites. Chitika tracks the searches a consumer has conducted, the websites visited, and the content viewed in order to serve advertising targeted to the individual consumer's interests. When a consumer visits a Web site within Chitika's network of Web site publishers, Chitika sets a new cookie or automatically receives a cookie it has previously set in the consumer's browser (the “Chitika tracking cookie”). Chitika uses cookies to serve advertisements to consumers that are targeted to their interests.

The Commission alleges that representations Chitika made in its privacy policy regarding consumers' ability to opt out of receiving tracking cookies were false or misleading. Chitika's privacy policy stated that consumers could opt out of receiving Chitika cookies. For those consumers who elected to opt out, Chitika set an “opt-out cookie” in the consumer's browser so that no additional cookies would be set in the consumer's browser, no additional information would be added to a previously set Chitika tracking cookie, and the data previously placed in the cookie would no longer be used to target advertisements to the consumer. From at least May 2008 to February 28, 2010, however, Chitika delivered opt-out cookies that were set to expire after ten (10) days. Accordingly, the complaint alleges that Chitika deceived consumers and violated Section 5 of the FTC Act by making an unqualified claim that consumers could opt out of targeted advertising when the opt out expired in ten (10) days.

Part I of the proposed order prohibits Chitika from misrepresenting (1) the extent of its data collection about consumers and (2) the extent to which consumers are able to control the collection, use, or sharing of their data.

Part II of the proposed order requires Chitika to take a number of steps to improve the transparency of, and consumers' ability to control, its collection of consumer data for online behavioral advertising. First, within thirty (30) days after service of the proposed order, Chitika must place a clear and prominent notice with a hyperlink on the homepage of its Web site that states: “We collect information about your activities on certain websites to send you targeted advertisements. To opt out of Chitika's targeted ads, click here. ” The mechanism that Chitika provides to allow consumers to prevent Chitika from collecting information about them must remain in effect for a minimum of five (5) years. Within close proximity to the mechanism, Chitika must disclose: (1) That Chitika collects information about consumers' activities on certain websites to deliver targeted ads; (2) that by opting out, Chitika will not collect this information to deliver such ads; (3) consumers' current choice status ( i.e., whether opted in or opted out of tracking); and (4) that consumers' choice is specific to the browser they are using ( i.e., if they switch browsers or devices, they will have to opt out again).

Part II of the proposed order includes two additional provisions. First, for a period of one (1) year, near the notice and hyperlink discussed above, Chitika's homepage must state that: “If you opted out of our targeted ads before March 1, 2010, the opt-out has expired and you must opt out again to avoid targeted ads.”

The final provision in Part II requires that within any behaviorally targeted advertisement that Chitika serves, it must include a hyperlink that takes consumers directly to the required choice mechanism. The hyperlink text must state: “Opt out?” When a consumer's cursor, or equivalent, is placed over the hyperlink, a box shall be visible that clearly and prominently states, “Opt out of Chitika's targeted ads.”

Part III of the proposed order restricts Chitika's use of any data that it collected from consumers prior to March 1, 2010, the date on which Chitika extended the expiration date of its opt-out cookies from ten (10) days to ten (10) years. Specifically, the proposed order prevents Chitika from using, selling, or transferring “any information that can be associated with a Chitika user or a Chitika user's computer or device” that the company obtained prior to March 1, 2010. In addition to restricting the use of this data, within sixty (60) days after the service of the order, Chitika must delete any such information stored in Chitika users' cookies and any information retained in Chitika's files that would allow the information to be associated with a particular consumer or that consumer's computer or device.

Parts IV through VIII of the proposed order are reporting and compliance provisions. Part IV requires Chitika to retain documents relating to its compliance with the order. Part V requires dissemination of the order to all current and future principals, officers, directors, managers, employees, agents, and representatives having responsibilities relating to the subject matter of the order. Part VI ensures notification to the FTC of changes in corporate status. Part VII mandates that Chitika submit a report to the Commission detailing its compliance with the order. Part VIII provides that the order expires after twenty (20) years, with certain exceptions.

The purpose of the analysis is to aid public comment on the proposed order. It is not intended to constitute an official interpretation of the proposed order or to modify its terms in any way.

Section 111 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110-275) and section 2 of the QI Program Supplemental Funding Act of 2008 (the SFA) (Pub. L. 110-379) provided $480 million for FY 2009 and $150 million for the first quarter of FY 2010 (that is, through December 31, 2009). Section 5005 of the American Recovery and Reinvestment Act of 2009 (ARRA, Pub. L. 111-5, enacted on February 17, 2009) extended the QI program by providing $412.5 million in additional funds for the remaining three quarters of FY 2010 and $150 million in funds for the first quarter of 2011 (that is, through December 31, 2010).

Most recently with respect to funding for the QI program for FY 2010, section 3 of the “Emergency Aid to American Survivors of the Haiti Earthquake Act” enacted on January 27, 2010 (Haiti Earthquake Act, Pub. L. 111-127) amended section 1933(g)(2)(M) of the Social Security Act (the Act) to provide an additional $50 million in funding for States' FY 2010 QI allotments. Prior to enactment of the Haiti Earthquake Act, there was only $562.5 million available for States' FY 2010 QI allotments. Under the current Medicaid statute, as amended by the Haiti Earthquake Act, a total of $612.5 million is available for States' QI program in FY 2010.

As previously stated, section 5005 of the American Recovery and Reinvestment Act of 2009 (ARRA, Pub. L. 111-5, enacted on February 17, 2009) extended the QI program by providing $150 million in additional funds for the first quarter of FY 2011 (that is, through December 31, 2010). Section 3 of the “Emergency Aid to American Survivors of the Haiti Earthquake Act” enacted on January 27, 2010 (Haiti Earthquake Act, Pub. L. 111-127) amended section 1933(g)(2)(M) of the Social Security Act (the Act) and provided an additional $15 million for States' FY 2011 QI allotments; that brings the total funds available for the QI program in FY 2011 to $165 million. Most recently, section 110 of the Medicare and Medicaid Extenders Act of 2010 (Pub. L. 111-309, enacted on December 15, 2010) amended section 1933 of the Social Security Act and provides for $720 million for the QI program in FY 2011 in addition to the currently available $165 million for a total of $885 million available for funding the QI program for FY 2011. Finally, the Medicare and Medicaid Extenders Act of 2010 (Pub. L. 111-309) also made available $280 million for the QI program for the first quarter of FY 2012 (that is, through December 31, 2011).

The amounts of the final FY 2010 and preliminary FY 2011 QI allotments, as contained in this notice, were determined in accordance with the methodology set forth in existing regulations at 42 CFR 433.10(c)(5), as amended in the Federal Register published on November 24, 2008 (73 FR 70893), and reflecting funding for the QI program made available under the legislation discussed above.

The final QI allotments for FY 2010 and the preliminary QI allotments for FY 2011 are shown by State in Chart 1 and Chart 2 below, respectively:

The following describes the information contained in the columns of Chart 1 and Chart 2:

Column A— State. Column A shows the name of each State.

Columns B through D show the determination of an Initial QI Allotment for FY 2010 (Chart 1) or FY 2011 (Chart 2) for each State, based only on the indicated Census Bureau data.

Column B— Number of Individuals. Column B contains the estimated average number of Medicare beneficiaries for each State that are not covered by Medicaid whose family income is at least 120 but less than 135 percent of the federal poverty level. With respect to the final FY 2010 QI allotment (Chart 1), Column B contains the number of such individuals for the years 2006 through 2008, as obtained from the Census Bureau's Annual Social and Economic Supplement to the 2009 Current Population Survey. With respect to the preliminary FY 2011 QI allotment (Chart 2), Column B contains the number of such individuals for the years 2007 through 2009, as obtained from the Census Bureau's Annual Social and Economic Supplement to the 2010 Current Population Survey.

Column C— Percentage of Total. Column C provides the percentage of the total number of individuals for each State, that is, the Number of Individuals for the State in Column B divided by the sum total of the Number of Individuals for all States in Column B.

Column D— Initial QI Allotment. Column D contains each State's Initial QI Allotment for FY 2010 (Chart 1) or FY 2011 (Chart 2), calculated as the State's Percentage of Total in Column C multiplied by the total amount available Nationally for QI allotments for the fiscal year. The total amount available Nationally for QI allotments each fiscal year is $612,500,000 for FY 2010 (Chart 1) and $885,000,000 for FY 2011 (Chart 2).

Columns E through L show the determination of the States' Final QI Allotments for FY 2010 (Chart 1) or Preliminary QI Allotments for FY 2011 (Chart 2).

Column E— FY 2010 Estimated QI Expenditures. Column E contains the States' estimates of their total QI expenditures for FY 2010 (Chart 1) or FY 2011 (Chart 2) based on information obtained from States in the summer of 2010.

Column F— Need (Difference). Column F contains the additional amount of QI allotment needed for those States whose estimated expenditures in Column E exceeded their Initial QI allotments in Column D for FY 2010 (Chart 1) or for FY 2011 (Chart 2) for such States, Column F shows the amount in Column E minus the amount in Column D. For other “Non-Need” States, Column F shows “NA”.

Column G— Percent of Total Need States. For States whose projected QI expenditures in Column E are greater than their initial QI allotment in Column D for FY 2010 (Chart 1) or FY 2011 (Chart 2), respectively, Column G shows the percentage of total need, determined as the amount for each Need State in Column F divided by the sum of the amounts for all States in Column F. For Non-Need States, the entry in Column G is “NA”.

Column H— Reduction Pool for Non-Need States. Column H shows the amount of the pool of surplus QI allotments for FY 2010 (Chart 1) or FY 2011 (Chart 2), respectively, for those States that project QI expenditures for the fiscal year that are less than the Initial QI allotment for the fiscal year (referred to as non-need States). For States whose estimates of QI expenditures for FY 2010 or FY 2011, respectively, in Column E are equal to or less than their Initial FY 2010 or FY 2011 QI allotments in Column D for FY 2010 or FY 2011, Column H shows the amount in Column D minus the amount in Column E. For the States with a need, Column H shows “Need”. The reduction pool of excess QI allotments is equal to the sum of the amounts in Column H.

Column I— Percent of Total Non-Need States. For States whose projected QI expenditures in Column E are less than their Initial QI allotment in Column D for FY 2010 (Chart 1) or FY 2011 (Chart 2), Column I shows the percentage of the total reduction pool in Column H, determined as the amount for each Non-Need State in Column H divided by the sum of the amounts for all States in Column H. For Need States, the entry in Column I is “Need”.

Column J— Reduction Adjustment for Non-Need States. Column J shows the amount of adjustment needed to reduce the Initial QI allotments in Column D for FY 2010 (Chart 1) or FY 2011 (Chart 2) for Non-Need States in order to address the total need shown in Column F. The amount in Column J is determined as the percentage in column I for Non-Need States multiplied by the lesser of the total need in Column F (equal to the sum of Needs in Column F) or the total Reduction Pool in Column H (equal to the sum of the Non-Need amounts in Column H). For Need States, the entry in Column J is “Need”.

Column K— Increase Adjustment for Need States.

Column K shows the amount of adjustment to increase the Initial QI Allotment in Column D for FY 2010 (Chart 1) or FY 2011 (Chart 2) for Need States in order to address the total need shown for the fiscal year in Column F. The amount in Column K is determined as the percentage in Column G for Need States multiplied by the lesser of the total need in Column F (equal to the sum of Needs in Column F) or the total Reduction Pool in Column H (equal to the sum of the Non-Need amounts in Column H). For Non-Need States, the entry in Column K is “NA”.

Column L— Final FY 2010 QI Allotment (Chart 1) or Preliminary FY 2011 QI Allotment (Chart 2).

Column L contains the Final QI Allotment for each State for FY 2010 (Chart 1) or the Preliminary QI Allotment for FY 2011 (Chart 2). For States that need additional QI allotment amounts for the fiscal year based on Estimated QI Expenditures in Column E as compared to their Initial QI allotments in Column D for the fiscal year (States with a projected need amount are shown in Column F), Column L is equal to the Initial QI allotment in Column D for FY 2010 (Chart 1) or FY 2011 (Chart 2) plus the amount determined in Column K for Need States. For Non-Need States (States with a projected surplus in Column H), Column L is equal to the QI Allotment in Column D reduced by the Reduction Adjustment amount in Column J.

We ordinarily publish a notice of proposed rulemaking in the Federal Register and invite public comment on a proposed rule. The notice of proposed rulemaking includes a reference to the legal authority under which the rule is proposed, and the terms and substance of the proposed rule, or a description of the subjects and issues involved. This procedure can be waived, however, if an agency finds good cause that a notice-and-comment procedure is impracticable, unnecessary, or contrary to the public interest, and incorporates a statement of the finding and its reasons in the rule issued. In addition, we also normally provide a delay of 30 days in the effective date. However, if adherence to this procedure would be impractical, unnecessary, or contrary to public interest, we may waive the delay in the effective date in accordance with the Administrative Procedure Act (5 U.S.C. 551 et seq. ).

We are publishing this notice without a comment period or delay in effective date because of the need to notify individual States of the limitations on Federal funds for their Medicaid expenditures for payment of Medicare Part B premiums for qualifying individuals. Some States have experienced deficits in their current allotments that have caused them to deny benefits to eligible applicants, while other States project a surplus in their allotments. This notice adjusts the allocation of Federal funds, which will reduce the impact of States denying coverage to eligible QIs when there is sufficient funding to cover all or some of these individuals. Because access to Medicare Part B coverage for QIs, who without this coverage would have difficulty paying for needed health care, is critically important, we believe that it is in the public interest to waive the usual notice and comment procedure which we undertake before making a rule final. Moreover, we are not making any changes to the process we use for allocating allotments. We are simply implementing a process already set forth in regulations. For these reasons, we also believe a notice and comment process would be unnecessary.

Therefore, for the reasons discussed above, we find that good cause exists to dispense with the normal requirement that a notice cannot become effective any earlier than 30 days after its publication. States that will have access to additional funds for QIs need to know that these funds are available as soon as possible. While we believe the surplus States that will have diminished amounts available for this FY will have sufficient funds for enrolling all potential QIs in their States, they also need to know as soon as possible that a certain amount of their unused allocation will no longer be available to them for this FY.

This document does not impose information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 35).

We have examined the impact of this notice as required by Executive Order 12866 (September 1993, Regulatory Planning and Review), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132 on Federalism and the Congressional Review Act (5 U.S.C. 804(2)).

Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any one year). This notice does not reach the economic threshold and thus is not considered a major rule.

The RFA requires agencies to analyze options for regulatory relief for small businesses. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $7 million to $34.5 million in any one year. Individuals and States are not included in the definition of a small entity.

This notice codifies our procedures for implementing provisions of the Balanced Budget Act of 1997 to allocate, among the States, Federal funds to provide Medicaid payment for Medicare Part B premiums for low-income Medicare beneficiaries. The total amount of Federal funds available during a Federal fiscal year and the formula for determining individual State allotments are specified in the law. We have applied the statutory formula for the State allotments. Because the data specified in the law were not initially available, we used comparable data from the U.S. Census Bureau on the number of possible qualifying individuals in the States. This notice also permits, in a specific circumstance, reallocation of funds to enable enrollment of all eligible individuals to the extent of the available funding.

We believe that the statutory provisions implemented in this notice will have a positive effect on States and individuals. Federal funding at the 100 percent matching rate is available for Medicare cost-sharing for Medicare Part B premium payments for qualifying individuals and, with the reallocation of the State allotments, a greater number of low-income Medicare beneficiaries will be eligible to have their Medicare Part B premiums paid under Medicaid. The changes in allotments will not result in fewer individuals receiving the QI benefit in any State. The FY 2010 and FY 2011 costs for this provision have been included in the Mid-session Review of the FY 2011 President's Budget.

Section 1102(b) of the Social Security Act requires us to prepare a regulatory impact analysis for any rule that may have a significant impact on the operations of a substantial number of small rural hospitals. The analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has fewer than 100 beds.

We are not preparing analyses for either the RFA or section 1102(b) of the Act because we have determined and certify that this notice will not have a significant economic impact on a substantial number of small entities or a significant impact on the operations of a substantial number of small rural hospitals.

Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule that may result in expenditure in any one year by State, local, or tribal governments, in the aggregate, or by the private sector, of $130 million. This notice will have no consequential effect on the governments mentioned or on the private sector.

Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a rule that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has federalism implications. Since this notice does not impose any costs on State or local governments, the requirements of E.O. 13132 are not applicable.

In accordance with the provisions of Executive Order 12866, this notice was not reviewed by the Office of Management and Budget.

On February 26, 2010, the Center for Devices and Radiological Health (CDRH) issued a not approvable letter in response to the premarket approval application (PMA) (PMA P080009) submitted by EES for the SEDASYS system. The SEDASYS system is intended for use by gastroenterologists as a drug-delivery system for the administration of propofol for minimal-to-moderate sedation in healthy patients undergoing a colonoscopy or esophagogastroduodenoscopy. CDRH determined the PMA for the SEDASYS system not to be approvable under § 814.44(f) (21 CFR 814.44(f)) because it concluded that the data and information offered in support of the PMA did not provide a reasonable assurance that the device is safe under the conditions of use prescribed, recommended, or suggested in the proposed labeling, as required by section 515(d)(2)(A) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

On March 25, 2010, EES requested administrative review of the not approvable letter. Submitted in the form of a petition for reconsideration under 21 CFR 10.33 ( see § 814.44(f)(2)), EES's request stated that, in accordance with § 814.44(f), EES considered the not approvable letter to be a denial of approval of PMA P080009 under § 814.45 (21 CFR 814.45). Pursuant to section 515(d)(4) of the FD&C Act, EES requested review of this denial under section 515(g)(2) (21 U.S.C. 360e(g)(2)) of the FD&C Act.

Accordingly, as required by § 814.45(e)(3), CDRH issued an order denying approval of the PMA for the SEDASYS system on October 26, 2010 (Ref. 1). Pursuant to section 515(g)(2) of the FD&C Act, on November 5, 2010, FDA granted EES's petition for review of the order denying PMA P080009.

In accordance with section 515(g)(2) of the FD&C Act, the Commissioner of Food and Drugs (the Commissioner) or her designee is referring PMA P080009 and the basis for the order denying its approval to an advisory committee of qualified experts. After independent study of the data and information furnished by the parties, and other data and information before it, the advisory committee will submit to the Commissioner a report and recommendation with respect to the order, together with the underlying data and information and a statement of the reasons or basis for the recommendation (section 515(g)(2)(A) of the FD&C Act). The Commissioner will provide a copy of that report and recommendation to the petitioner (id.), as well as to CDRH. At this time, the Commissioner also anticipates offering both the petitioner and CDRH the opportunity to submit comments on the report and recommendation before the final order is rendered. In keeping with section 515(g)(2)(C) of the FD&C Act, the Commissioner will make the report and recommendation public and issue an order either affirming or reversing the denial of approval.

In 1999, FDA established a standing advisory committee known as the Medical Devices Dispute Resolution Panel to provide advice to the Commissioner on complex or contested scientific issues between FDA and medical device sponsors, applicants, or manufacturers relating to specific products, marketing applications, regulatory decisions and actions by FDA, and Agency guidance and policies (see the charter for the Medical Devices Advisory Committee (MDAC charter)) (Ref. 2). In a guidance document entitled “Resolving Scientific Disputes Concerning the Regulation of Medical Devices, A Guide to Use of the Medical Devices Dispute Resolution Panel” (July 2, 2001) (the Guidance), FDA clarified that the Medical Devices Dispute Resolution Panel was established, in part, to receive referrals of petitions for advisory committee review under section 515(g)(2) of the FD&C Act (Ref. 3).

Accordingly, the Commissioner will refer EES's petition for review to this advisory committee for a report and recommendation with respect to the order denying PMA P080009. The Office of the Commissioner will select the temporary members of, and any consultants to, the advisory committee, and otherwise ensure that the proceeding is conducted in accordance with section 515(g)(2) of the FD&C Act, the Federal Advisory Committee Act, FDA's regulations in 21 CFR part 14 governing its public advisory committees, the MDAC charter, and any other applicable laws or regulations. The Office of the Commissioner will also perform the other duties assigned to FDA under section 515(g)(2) of the FD&C Act. The Office of the Commissioner will publish a Federal Register notice concerning the advisory committee meeting at a later date.

Although no statute or regulation requires that separation of functions be applied to this proceeding, the Agency is observing separation of functions as a matter of policy in this matter. As the Center responsible for the action under review, CDRH will be, like EES, a party to the advisory committee hearing and will be responsible for presenting its position at that meeting.

In addition, as a corollary to its decision to observe a separation of functions, until the Commissioner issues an order either affirming or reversing the order denying approval of PMA P080009, the Office of the Commissioner will not engage in any ex parte communication (see 21 CFR 10.3(a)) with anyone participating as a party to the hearing or any person outside the Agency with respect to the matter under consideration. 1 Any written ex parte communication will be immediately served on the two parties and filed in the docket. Any oral ex parte communication will be immediately memorialized in writing, served on both parties to the hearing, and filed in the docket.

All documents filed in this matter are filed under Docket No. FDA-2010-P-0176 and are available for public review in the Division of Dockets Management ( see ADDRESSES ) between 9 a.m. and 4 p.m., Monday through Friday. Persons with access to the Internet may obtain documents in the docket at http://www.regulations.gov .

The following references are on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20857, under Docket No. FDA-2010-P-0176 and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

1. Letter from Christy Foreman, FDA, CDRH, to Ken Charak, Ethicon Endo-Surgery, Inc., containing the order denying approval of the PMA for the SEDASYS system, October 26, 2010.

2. Charter Medical Devices Advisory Committee; Charter Amendment, Medical Devices Advisory Committee; FDA; July 15, 2008, http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ucm124098.htm .

3. “Resolving Scientific Disputes Concerning the Regulation of Medical Devices, A Guide To Use of the Medical Devices Dispute Resolution Panel; Final Guidance for Industry and FDA” FDA, CDRH; July 2, 2001, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm .

The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

FDA recently approved for marketing the human drug product VPRIV (velaglucerase alfa). VPRIV is indicated for long-term enzyme replacement therapy for pediatric and adult patients with type 1 Gaucher Disease. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for VPRIV (U.S. Patent No. 7,138,262) from Shire Human Genetic Therapies, Inc., and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated September 30, 2010, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of VPRIV represented the first permitted commercial marketing or use of the product. Thereafter, the Patent and Trademark Office requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for VPRIV is 2,221 days. Of this time, 2,041 days occurred during the testing phase of the regulatory review period, while 180 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became effective: January 30, 2004. The applicant claims May 20, 2004, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was January 30, 2004, which was 30 days after FDA receipt of the IND.

2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: August 31, 2009. FDA has verified the applicant's claim that the new drug application (NDA) for VPRIV (NDA 22-575) was initially submitted on August 31, 2009.

3. The date the application was approved: February 26, 2010. FDA has verified the applicant's claim that NDA 22-575 was approved on February 26, 2010.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 687 days of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management ( see ADDRESSES ) either electronic or written comments and ask for a redetermination by May 20, 2011. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by September 19, 2011. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. ( See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Interested persons may submit to the Division of Dockets Management ( see ADDRESSES ) electronic or written comments and written petitions. It is only necessary to send one set of comments. It is no longer necessary to send three copies of mailed comments. However, if you submit a written petition, you must submit three copies of the petition. Identify comments with the docket number found in brackets in the heading of this document.

Comments and petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

FDA recently approved for marketing the human biologic product ATRYN (antithrombin (recombinant)). ATRYN is indicated for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for ATRYN (U.S. Patent No. 6,441,145) from GTC Biotherapeutics, Inc., and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated February 17, 2010, FDA advised the Patent and Trademark Office that this human biological product had undergone a regulatory review period and that the approval of ATRYN represented the first permitted commercial marketing or use of the recombinant product. Thereafter, the Patent and Trademark Office requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for ATRYN is 4,468 days. Of this time, 4,285 days occurred during the testing phase of the regulatory review period, while 183 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: November 15, 1996. The applicant claims November 14, 1996, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was November 15, 1996, which was 30 days after FDA receipt of the IND.

2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): August 8, 2008. The applicant claims January 31, 2008, as the date the biologics license application (BLA) for ATRYN (BLA 125284) was initially submitted. However, FDA records indicate that BLA 125284 was submitted on August 8, 2008.

3. The date the application was approved: February 6, 2009. FDA has verified the applicant's claim that BLA 125284 was approved on February 6, 2009.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,243 days of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management ( see ADDRESSES ) either electronic or written comments and ask for a redetermination by May 20, 2011. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by September 19, 2011. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. ( See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Interested persons may submit to the Division of Dockets Management ( see ADDRESSES ) electronic or written comments and written petitions. It is only necessary to send one set of comments. It is no longer necessary to send three copies of mailed comments. However, if you submit a written petition, you must submit three copies of the petition. Identify comments with the docket number found in brackets in the heading of this document.

Comments and petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collections. There is one ICR for each Collection.

The Coast Guard invites comments on whether these ICRs should be granted based on the Collections being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collections; (2) the accuracy of the estimated burden of the Collections; (3) ways to enhance the quality, utility, and clarity of information subject to the Collections; and (4) ways to minimize the burden of the Collections on respondents, including the use of automated collection techniques or other forms of information technology. In response to your comments, we may revise these ICRs or decide not to seek approval for the Collections. We will consider all comments and material received during the comment period.

We encourage you to respond to this request by submitting comments and related materials. Comments must contain the OMB Control Number of the ICR and the docket number of this request, [USCG-2011-0119], and must be received by May 20, 2011. We will post all comments received, without change, to http://www.regulations.gov. They will include any personal information you provide. We have an agreement with DOT to use their DMF. Please see the “Privacy Act” paragraph below.

If you submit a comment, please include the docket number [USCG-2011-0119], indicate the specific section of the document to which each comment applies, providing a reason for each comment. You may submit your comments and material online ( via http://www.regulations.gov ), by fax, mail, or hand delivery, but please use only one of these means. If you submit a comment online via http://www.regulations.gov, it will be considered received by the Coast Guard when you successfully transmit the comment. If you fax, hand deliver, or mail your comment, it will be considered as having been received by the Coast Guard when it is received at the DMF. We recommend you include your name, mailing address, an e-mail address, or other contact information in the body of your document so that we can contact you if we have questions regarding your submission.

You may submit your comments and material by electronic means, mail, fax, or delivery to the DMF at the address under ADDRESSES ; but please submit them by only one means. To submit your comment online, go to http://www.regulations.gov, and type “USCG-2011-0119” in the “Keyword” box. If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8½ by 11 inches, suitable for copying and electronic filing. If you submit comments by mail and would like to know that they reached the Facility, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received during the comment period and will address them accordingly.

Viewing comments and documents: To view comments, as well as documents mentioned in this Notice as being available in the docket, go to http://www.regulations.gov, click on the “read comments” box, which will then become highlighted in blue. In the “Keyword” box insert “USCG-2011-0019” and click “Search.” Click the “Open Docket Folder” in the “Actions” column. You may also visit the DMF in Room W12-140 on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Anyone can search the electronic form of comments received in dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc. ). You may review a Privacy Act statement regarding Coast Guard public dockets in the January 17, 2008, issue of the Federal Register (73 FR 3316).

1. Title: Security Zones, Regulated Navigation Areas, and Safety Zones.

OMB Control Number: 1625-0020.

Summary: The Coast Guard collects this information only when someone seeks a security zone, regulated navigation area, or safety zone. It uses the information to assess the need to establish one of these areas.

Need: Section 1226 and 1231 of 33 U.S.C. and 50 U.S.C. 191 and 195, and parts 6 and 165 of 33 CFR give the Coast Guard Captain of the Port (COTP) the authority to designate security zones in the U.S. for as long as the COTP deems necessary to prevent damage or injury. Section 1223 of 33 U.S.C. authorizes the Coast Guard to prescribe rules to control vessel traffic in areas he or she deems hazardous because of reduced visibility, adverse weather, or vessel congestion. Section 1225 of 33 U.S.C. authorizes the Coast Guard to establish rules to allow the designation of safety zones where access is limited to authorized persons, vehicles, or vessels to protect the public from hazardous situations.

Forms: Not applicable.

Respondents: Federal, State, and local government agencies, owners and operators of vessels and facilities.

Frequency: On occasion.

Burden Estimate: The estimated burden has decreased from 296 hours to 272 hours a year.

2. Title: Application for Tonnage Measurement of Vessels.

OMB Control Number: 1625-0022.

Summary: The information is used by the Coast Guard to determine a vessel's tonnage. Tonnage in turn helps to determine licensing, inspection, safety requirements, and operating fees.

Need: Under 46 U.S.C. 14104 certain vessels must be measured for tonnage. Coast Guard regulations for this measurement are contained in 46 CFR part 69.

Forms: CG-5397.

Respondents: Owners of vessels.

Frequency: On occasion.

Burden Estimate: The estimated burden has decreased from 33,499 hours to 19,160 hours a year.

3. Title: Self-propelled Liquefied Gas Vessels.

OMB Control Number: 1625-0029.

Summary: We need the information sought in this collection, which includes forms CG-4355 and CG-5148, to ensure compliance with our rules for the design and operation of liquefied gas carriers.

Need: Section 3703 and 9101 of 46 U.S.C. authorizes the Coast Guard to establish regulations to protect life, property, and the environment from the hazards associated with the carriage of dangerous liquid cargo in bulk. Part 154 of 46 CFR prescribes these rules for the carriage of liquefied gases in bulk on self-propelled vessels by governing the design, construction, equipment, and operation of these vessels and the safety of personnel aboard them.

Forms: CG-4355, CG-5148.

Respondents: Owners and operators of self-propelled vessels carrying liquefied gas.

Frequency: On occasion.

Burden Estimate: The estimated burden has increased from 6,566 hours to 6,754 hours a year.

4. Title: Plan Approval and Records for Electrical Engineering Regulations—Title 46 CFR Subchapter J.

OMB Control Number: 1625-0031.

Summary: The information sought here is needed to ensure compliance with our rules on electrical engineering for the design and construction of U.S.-flag commercial vessels.

Need: Sections 3306 and 3703 of 46 U.S.C. authorize the Coast Guard to establish rules to promote the safety of life and property in commercial vessels. The electrical engineering rules appear at 46 CFR chapter I, subchapter J (parts 110 through 113).

Forms: None.

Respondents: Owners, operators, shipyards, designers, and manufacturers of vessels.

Frequency: On occasion.

Burden Estimate: The estimated burden has increased from 3,529 hours to 4,754 hours a year.

The Public Advisory Committee was created by Paragraph V.A.4 of the Memorandum of Agreement and Consent Decree entered into by the United States of America and the State of Alaska on August 27, 1991, and approved by the United States District Court for the District of Alaska in settlement of United States of America v. State of Alaska, Civil Action No. A91-081 CV. The meeting agenda will include a review of the proposals received in response to the Invitation for Fiscal Year 2012 project proposals.