The World Trade Organization (WTO) was established on January 1, 1995, as the common international institutional framework for the conduct of trade relations among its members in matters related to the Uruguay Round Trade Agreements. The WTO is the successor organization to the General Agreement on Tariffs and Trade (GATT). U.S. membership in the WTO was approved and the Uruguay Round Agreements Act was signed into law by the President on December 8, 1994. The Uruguay Round Agreements became effective, with respect to the United States, on January 1, 1995. Pursuant to section 491 of the Trade Agreements Act of 1979, as amended, the President is required to designate an agency to be “responsible for informing the public of the sanitary and phytosanitary (SPS) standard-setting activities of each international standard-setting organization.” The main organizations are Codex, the World Organisation for Animal Health, and the International Plant Protection Convention. The President, pursuant to Proclamation No. 6780 of March 23, 1995 (60 FR 15845), designated the U.S. Department of Agriculture as the agency responsible for informing the public of the SPS standard-setting activities of each international standard-setting organization. The Secretary of Agriculture has delegated to the Office of Food Safety the responsibility to inform the public of the SPS standard-setting activities of Codex. The Office of Food Safety has, in turn, assigned the responsibility for informing the public of the SPS standard-setting activities of Codex to the U.S. Codex Office.

Codex was created in 1963 by two United Nations organizations, the Food and Agriculture Organization (FAO) and the World Health Organization (WHO). Codex is the principal international organization for establishing standards for food. Through adoption of food standards, codes of practice, and other guidelines developed by its committees and by promoting their adoption and implementation by governments, Codex seeks to protect the health of consumers, ensure fair practices in the food trade, and promote coordination of food standards work undertaken by international governmental and nongovernmental organizations. In the United States, U.S. Codex activities are managed and carried out by the United States Department of Agriculture (USDA); the Food and Drug Administration (FDA), Department of Health and Human Services (HHS); the National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC); and the Environmental Protection Agency (EPA).

As the agency responsible for informing the public of the SPS standard-setting activities of Codex, the Office of Food Safety publishes this notice in the Federal Register annually. Attachment 1 (Sanitary and Phytosanitary Activities of Codex) sets forth the following information:

1. The SPS standards under consideration or planned for consideration; and

2. For each SPS standard specified:

a. A description of the consideration or planned consideration of the standard;

b. Whether the United States is participating or plans to participate in the consideration of the standard;

c. The agenda for United States participation, if any; and

d. The agency responsible for representing the United States with respect to the standard.

This notice also solicits public comment on standards that are currently under consideration or planned for consideration and recommendations for new standards. The delegate, in conjunction with the responsible agency, will take the comments received into account in participating in the consideration of the standards and in proposing matters to be considered by Codex.

The United States delegate will facilitate public participation in the United States Government's activities relating to Codex Alimentarius. The United States delegate will maintain a list of individuals, groups, and organizations that have expressed an interest in the activities of the Codex committees and will disseminate information regarding United States delegation activities to interested parties. This information will include the status of each agenda item; the United States Government's position or preliminary position on the agenda items; and the time and place of planning meetings and debriefing meetings following Codex committee sessions. In addition, the U.S. Codex Office makes much of the same information available through its Web page, http://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/us-codex-alimentarius . If you would like to access or receive information about specific committees, please visit the Web page or notify the appropriate U.S. delegate or the U.S. Codex Office, Room 4861, South Agriculture Building, 1400 Independence Avenue SW., Washington, DC 20250-3700 ( uscodex@fsis.usda.gov ).

The information provided in Attachment 1 describes the status of Codex standard-setting activities by the Codex Committees for the time periods from June 1, 2013, to May 31, 2014, and June 1, 2014, to May 31, 2015. Attachment 2 provides a list of U.S. Codex Officials (including U.S. delegates and alternate delegates). A list of forthcoming Codex sessions may be found at: http://www.codexalimentarius.org/meetings-reports/en/.

FSIS will announce this notice online through the FSIS Web page located at: http://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/fsis-notices .

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. 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/wps/portal/fsis/programs-and-services/email-subscription-service. 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.

The Codex Alimentarius Commission will hold its Thirty Seventh Session July 14-18, 2014, in Geneva, Switzerland. At that time, it will consider standards, codes of practice, and related matters forwarded to the Commission by the general subject committees, commodity committees, and ad hoc Task Forces for adoption as Codex standards and guidance. The Commission will also consider the implementation status of the Codex Strategic Plan, the management of the Trust Fund for the Participation of Developing Countries and Countries in transition in the work of the Codex Alimentarius, as well as financial and budgetary issues.

Prior to the Commission meeting, the Executive Committee will meet at its Sixty-ninth session, July 8-11, 2014. It is composed of the chairperson; vice-chairpersons; seven members elected from the Commission from each of the following geographic regions: Africa, Asia, Europe, Latin America and the Caribbean, Near East, North America, and South-West Pacific; and regional coordinators from the six regional committees. The United States is the elected representative from North America. The Executive Committee will conduct a critical review of the elaboration of Codex standards; consider applications from international non-governmental organizations for observer status in Codex; consider the Codex Strategic Plan and the capacity of the Secretariat; review matters arising from reports of Codex Committees and proposals for new work; and review the Food and Agriculture Organization and the World Health Organisation (FAO/WHO) Trust Fund for Enhanced Participation in Codex.

Responsible Agency: USDA/FSIS.

U.S. Participation: Yes.

The Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF) determines priorities for the consideration of residues of veterinary drugs in foods and recommends Maximum Residue Limits (MRLs) for veterinary drugs. The Committee also develops codes of practice, as may be required, and considers methods of sampling and analysis for the determination of veterinary drug residues in food. A veterinary drug is defined as any substance applied or administered to any food producing animal, such as meat or milk producing animals, poultry, fish or bees, whether used for therapeutic, prophylactic or diagnostic purposes, or for modification of physiological functions or behavior.

A Codex Maximum Residue Limit (MRL) for Residues of Veterinary Drugs is the maximum concentration of residue resulting from the use of a veterinary drug (expressed in mg/kg or ug/kg on a fresh weight basis) that is recommended by the Codex Alimentarius Commission to be permitted or recognized as acceptable in or on a food. Residues of a veterinary drug include the parent compounds or their metabolites in any edible portion of the animal product, and include residues of associated impurities of the veterinary drug concerned. An MRL is based on the type and amount of residue considered to be without any toxicological hazard for human health as expressed by the Acceptable Daily Intake (ADI) or on the basis of a temporary ADI that utilizes an additional safety factor. The MRL also takes into account other relative public health risks as well as food technological aspects.

When establishing an MRL, consideration is also given to residues that occur in food of plant origin or the environment. Furthermore, the MRL may be reduced to be consistent with official recommended or authorized usage, approved by national authorities, of the veterinary drugs under practical conditions.

An Acceptable Daily Intake (ADI) is an estimate made by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) of the amount of a veterinary drug, expressed on a body weight basis, which can be ingested daily in food over a lifetime without appreciable health risk.

The Committee held its 21st session in Minneapolis, Minnesota, August 26-30, 2013. The following items are to be considered for adoption by the 37th session of the Commission in July 2014:

To be considered for adoption:

To be considered at Step 5/8:

The Committee will continue working on:

Responsible Agencies: HHS/FDA/CVM; USDA/FSIS.

U.S. Participation: Yes.

The Codex Committee on Contaminants in Foods (CCCF) establishes or endorses permitted maximum levels (ML) and, where necessary, revises existing guidelines levels for contaminants and naturally occurring toxicants in food and feed; prepares priority lists of contaminants and naturally occurring toxicants for risk assessment by the Joint FAO/WHO Expert Committee on Food Additives; considers and elaborates methods of analysis and sampling for the determination of contaminants and naturally occurring toxicants in food and feed; considers and elaborates standards or codes of practice for related subjects; and considers other matters assigned to it by the Commission in relation to contaminants and naturally occurring toxicants in food and feed.

The Committee held its Eighth Session in The Hague, The Netherlands, March 31-April 4, 2014. The relevant document is REP14/CF. The following items are to be considered for adoption by the 37th Session of the Commission in July 2014:

To be considered at Step 5/8:

The Committee will continue working on:

The Committee will work on the following discussion papers:

Responsible Agencies: HHS/FDA; USDA/FSIS.

U.S. Participation: Yes.

The Codex Committee on Food Additives (CCFA) establishes or endorses acceptable maximum levels (MLs) for individual food additives; prepares a priority list of food additives for risk assessment by the Joint FAO/WHO Expert Committee on Food Additives (JECFA); assigns functional classes to individual food additives; recommends specifications of identity and purity for food additives for adoption by the Codex Alimentarius Commission; considers methods of analysis for the determination of additives in food; and considers and elaborates standards or codes of practice for related subjects such as the labeling of food additives when sold as such. The 46th Session of the Committee met in Hong Kong, China, March 17-21, 2014. The relevant document is REP14/ FA. Immediately prior to the Plenary Session, there was a 2-day physical Working Group on the General Standard for Food Additives (GSFA) chaired by the United States.

The following items will be considered by the 37th Session of the Commission in July 2014.

To be considered for adoption:

To be considered for adoption at Step 8 & 5/8:

To be considered for adoption at Step 5/8:

The Committee will continue working on:

The Committee also agreed to hold a physical Working Group on the GSFA immediately preceding the 47th session of CCFA to be chaired by the United States. That group will discuss:

Responsible Agency: HHS/FDA.

U.S. Participation: Yes.

The Codex Committee on Pesticide Residues (CCPR) is responsible for establishing maximum limits for pesticide residues in specific food items or in groups of food; establishing maximum limits for pesticide residues in certain animal feeding stuffs moving in international trade where this is justified for reasons of protection of human health; preparing priority lists of pesticides for evaluation by the Joint FAO/WHO Meeting on Pesticide Residues (JMPR); considering methods of sampling and analysis for the determination of pesticide residues in food and feed; considering other matters in relation to the safety of food and feed containing pesticide residues and; establishing maximum limits for environmental and industrial contaminants showing chemical or other similarity to pesticides in specific food items or groups of food.

The 46th Session of the Committee met in Nanjing, China, May 5-10, 2014. The relevant document is REP14/PR. The following items will be considered at the 37th Session of the Codex Alimentarius Commission in July 2014.

For adoption:

To be considered at Steps 8 and 5/8:

The Committee will continue working on:

Responsible Agencies: EPA; USDA/FSIS.

U.S. Participation: Yes.

The Codex Committee on Methods of Analysis and Sampling (CCMAS) defines the criteria appropriate to Codex Methods of Analysis and Sampling; serves as a coordinating body for Codex with other international groups working on methods of analysis and sampling and quality assurance systems for laboratories; specifies, on the basis of final recommendations submitted to it by the bodies referred to above, reference methods of analysis and sampling appropriate to Codex standards which are generally applicable to a number of foods; considers, amends if necessary, and endorses as appropriate, methods of analysis and sampling proposed by Codex commodity committees, except for methods of analysis and sampling for residues of pesticides or veterinary drugs in food, the assessment of microbiological quality and safety in food, and the assessment of specifications for food additives; elaborates sampling plans and procedures, as may be required; considers specific sampling and analysis problems submitted to it by the Commission or any of its Committees; and defines procedures, protocols, guidelines or related texts for the assessment of food laboratory proficiency, as well as quality assurance systems for laboratories.

The 35th Session of the Committee met in Budapest, Hungary, March 3-7, 2014. The relevant document is REP14/MAS. The following items will be considered by the Commission at its 37th Session in July 2014.

To be considered for adoption:

The Committee will continue working on:

Responsible Agencies: HHS/FDA; USDA/GIPSA.

The Codex Committee on Food Import and Export Inspection and Certification Systems is responsible for developing principles and guidelines for food import and export inspection and certification systems, with a view to harmonizing methods and procedures that protect the health of consumers, ensure fair trading practices, and facilitate international trade in foodstuffs; developing principles and guidelines for the application of measures by the competent authorities of exporting and importing countries to provide assurance, where necessary, that foodstuffs comply with requirements, especially statutory health requirements; developing guidelines for the utilization, as and when appropriate, of quality assurance systems to ensure that foodstuffs conform with requirements and promote the recognition of these systems in facilitating trade in food products under bilateral/multilateral arrangements by countries; developing guidelines and criteria with respect to format, declarations, and language of such official certificates as countries may require with a view towards international harmonization; making recommendations for information exchange in relation to food import/export control; consulting as necessary with other international groups working on matters related to food inspection and certification systems; and considering other matters assigned to it by the Commission in relation to food inspection and certification systems.

The next session of the Committee will meet in Brisbane, Australia, October 13-17, 2014. The following agenda items will be discussed:

Responsible Agencies: HHS/FDA; USDA/FSIS.

U.S. Participation: Yes.

The Codex Committee on Food Labelling drafts provisions on labeling applicable to all foods; considers, amends, and endorses draft specific provisions on labeling prepared by the Codex Committees drafting standards, codes of practice, and guidelines; and studies specific labeling problems assigned by the Codex Alimentarius Commission. The Committee also studies problems associated with the advertisement of food with particular reference to claims and misleading descriptions.

The Committee will hold its 42nd Session in Canada, October 21-24, 2014. The Committee plans to continue work on the following items:

Responsible Agencies: HHS/FDA; USDA/FSIS.

U.S. Participation: Yes.

The Codex Committee on Food Hygiene (CCFH):

The Committee held its 45th session in Hanoi, Viet Nam, November 11-15, 2013. The reference document is REP 14/FH. The following items will be considered by the Commission at its 37th Session in July 2014.

To be considered for adoption:

To be considered for adoption at Step 5/8:

The Committee agreed to request the Commission to approve new work on:

The merchandise subject to the order is PSF. The PSF subject to the order is currently classifiable under subheadings 5503.20.00.40, 5503.20.00.45, 5503.20.00.60, and 5503.20.00.65 of the Harmonized Tariff Schedule of the United States (HTSUS). The HTSUS subheadings are provided for convenience and customs purposes. 1 The written description is dispositive.

The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (IA ACCESS). Access to IA ACCESS is available to registered users at http://iaaccess.trade.gov , and it is available to all parties in the Central Records Unit, room 7046 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly on the Internet at http://enforcement.trade.gov/frn/index.html . A list of the topics discussed in the Preliminary Decision Memorandum is attached as an Appendix to this notice. The signed Preliminary Decision Memorandum and the electronic versions of the Preliminary Decision Memorandum are identical in content.

Nan Ya reported that it did not sell or export subject merchandise to the United States during the POR. 2 Based on record evidence, we preliminarily find that Nan Ya had no shipments during the POR.

The Department conducted this review in accordance with section 751(a)(2) of the Tariff Act of 1930, as amended (the Act). Export price is calculated in accordance with section 772 of the Act. Normal value is calculated in accordance with section 773 of the Act. For a full description of the methodology underlying our conclusions, see Preliminary Decision Memorandum.

As a result of this review, we preliminarily determine that a weighted-average dumping margin of 0.00 percent exists for FENC for the period May 1, 2012, through April 30, 2013.

We intend to disclose the calculations performed to parties in this proceeding within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b). Pursuant to 19 CFR 351.309(c), interested parties may submit cases briefs not later than 30 days after the date of publication of this notice. Rebuttal briefs, limited to issues raised in the case briefs, may be filed not later than five days after the date for filing case briefs. 3 Parties who submit case briefs or rebuttal briefs in this proceeding are encouraged to submit with each argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities. 4

Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, or to participate if one is requested, must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via IA ACCESS. An electronically filed document must be received successfully in its entirety by the Department's electronic records system, IA ACCESS, by 5 p.m. Eastern Time within 30 days after the date of publication of this notice. 5 Requests should contain: (1) The party's name, address and telephone number; (2) the number of participants; and (3) a list of issues to be discussed. Issues raised in the hearing will be limited to those raised in the respective case briefs.

The Department intends to issue the final results of this administrative review, including the results of its analysis of the issues raised in any written briefs, not later than 120 days after the date of publication of this notice, pursuant to section 751(a)(3)(A) of the Act.

Upon completion of the administrative review, the Department shall determine and U.S. Customs and Border Protection (CBP) shall assess antidumping duties on all appropriate entries. If FENC's weighted-average dumping margin is not zero or de minimis in the final results of this review, we will calculate importer-specific assessment rates on the basis of the ratio of the total amount of dumping calculated for an importer's examined sales and the total entered value of such sales in accordance with 19 CFR 351.212(b)(1). If FENC's weighted-average dumping margin is zero or de minimis in the final results of review, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties in accordance with the Final Modification for Reviews, i.e., “{w}here the weighted-average margin of dumping for the exporter is determined to be zero or de minimis, no antidumping duties will be assessed.”  6 If an importer-specific assessment rate is zero or de minimis, then the Department will instruct CBP to liquidate the appropriate entries without regard to antidumping duties in accordance with 19 CFR 351.106(c)(2).

The Department clarified its “automatic assessment” regulation on May 6, 2003. 7 This clarification will apply to entries of subject merchandise during the POR produced by FENC for which it did not know its 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.

Consistent with the Assessment Policy Notice, if we continue to find that Nan Ya had no shipments of subject merchandise to the United States in the final results of this review, we intend to instruct CBP to liquidate any existing entries of merchandise produced by Nan Ya and exported by other parties at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction.

We intend to issue instructions to CBP 15 days after publication of the final results of this review.

The following cash deposit requirements will be effective upon publication of the notice of final results of administrative review for all shipments of PSF from Taiwan entered, or withdrawn from warehouse, for consumption on or after the date of publication as provided by section 751(a)(2) of the Act: (1) The cash deposit rate for FENC will be equal to the weighted-average dumping margin established in the final results of this administrative review; (2) for merchandise exported by manufacturers or exporters not covered in this review but covered in a prior segment of the proceeding, the cash deposit rate will continue to be the company-specific rate published for the most recent period for which there is a completed segment of this proceeding; (3) if the exporter is not a firm covered in this review, a prior review, or the original investigation but the manufacturer is, the cash deposit rate will be the rate established for the most recent period for which there is a completed segment for the manufacturer of the merchandise; (4) the cash deposit rate for all other manufacturers or exporters will continue to be 7.31 percent. 8 These cash deposit requirements, when imposed, shall remain in effect until further notice.

This notice serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) 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 the subsequent assessment of double antidumping duties.

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

On May 7, 2014, the Department disclosed to interested parties its calculations for the Preliminary Determination. On May 13, 2014, we received ministerial error comments from Ajinomoto North America Inc. (“Petitioner”); and Langfang Meihua Bio-Technology Co., Ltd., Meihua Holdings Group Co., Ltd., and Tongliao Meihua Biological SCI-TECH Co., Ltd. (collectively, the Meihua Group), alleging that the Department made ministerial errors in the calculation of the Meihua Group's weighted-average dumping margin. 2

The scope of this investigation covers MSG, whether or not blended or in solution with other products. Specifically, MSG that has been blended or is in solution with other product(s) is included in this scope when the resulting mix contains 15 percent or more of MSG by dry weight. For a full description of the products covered by the less-than-fair-value investigation, see the Memorandum to Paul Piquado, Assistant Secretary, Enforcement and Compliance, from Christian Marsh, Deputy Assistant Secretary, “Preliminary Determination of the Less-Than-Fair-Value Investigation of Monosodium Glutamate from the People's Republic of China: Ministerial Error Allegations Memorandum,” dated concurrently with and hereby adopted by this notice (“Ministerial Error Memo”). The Ministerial Error Memo is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (“IA ACCESS”). Access to IA ACCESS is available to registered users at http://iaaccess.trade.gov, and is available to all parties in the Central Records Unit, which is in room 7046 of the main Department of Commerce building. A list of the issues discussed in the Ministerial Error Memo is attached to this notice an appendix.

Ministerial errors are defined in 19 CFR 351.224(f) as an error “in addition, subtraction, or other arithmetic function, clerical error resulting from inaccurate copying, duplication, or the like, and any similar type of unintentional error which the Secretary considers ministerial.” 19 CFR 351.224(e) provides that the Department “will analyze any comments received and, if appropriate, correct any significant ministerial error by amending the preliminary determination.” A significant ministerial error is defined as a ministerial error, the correction of which, singly or in combination with other errors, would result in: (1) A change of at least five absolute percentage points in, but not less than 25 percent of, the weighted-average dumping margin calculated in the original (erroneous) preliminary determination; or (2) a difference between a weighted-average dumping margin of zero or de minimis and a weighted-average dumping margin of greater than de minimis or vice versa. 3

After analyzing the ministerial error comments, we determine, in accordance with 19 CFR 351.224(e), that we made the following ministerial errors in our calculations for the Preliminary Determination: We inadvertently miscalculated the Meihua Group's organic bacteria protein by-product, high protein scrap by-product, foreign inland freight distance, home country distances and freight charges, 20-foot container weight for brokerage and handling expenses, and certain inputs for the production of MSG. Moreover, we determine that these errors in combination constitute a “significant ministerial error” as defined in 19 CFR 351.224(g)(1). Accordingly, we corrected these errors. As a result of correcting these errors in the calculation of the Meihua Group's weighted-average dumping margin, the weighted-average dumping margin for the companies granted separate-rate status must also be revised because the rate for those companies was derived from the Meihua Group's rate. 4 The weighted-average dumping margin for the PRC-wide entity also must be revised because it was based on the Meihua Group's highest transaction-specific dumping margin. 5 For a detailed discussion of these ministerial errors, as well as the Department's analysis, see the Ministerial Error Memo.

In accordance with 19 CFR 351.224(e), we are amending the Preliminary Determination of the less-than-fair-value investigation of MSG from the PRC. The revised weighted-average dumping margins are detailed below.

As a result of the correction of the ministerial error, the amended weighted-average dumping margins for the preliminary determination are as follows:

In accordance with section 733(d) of the Act, we will instruct CBP to require a cash deposit for all suspended entries, on or after the date of the publication of this notice in the Federal Register , at an ad valorem rate equal to the weighted-average dumping margins, as indicated in the chart above. These suspension of liquidation instructions will remain in effect until further notice.

In accordance with section 733(f) of the Act, we have notified the ITC of our amended preliminary affirmative determination of sales at LTFV. Section 735(b)(2) of the Act requires the ITC to make its final determination as to whether the domestic industry in the United States is materially injured, or threatened with material injury, by reason of imports of MSG, or sales (or the likelihood of sales) for importation, of the merchandise under consideration within 45 days of our final determination.

The Department will disclose calculations performed in connection with this amended preliminary determination within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).

This amended preliminary determination is issued and published in accordance with sections 733(f) and 777(i)(1) of the Act and 19 CFR 351.224(e).

The purpose of this meeting is to review a Bayesian modeling approach that generates maximum sustainable yield (MSY) estimates for Pacific coral reef ecosystem resources using available catch time series, a measure of population growth, carrying capacity, and biomass from NMFS underwater fish census surveys. At this meeting, a team of reviewers provided by the Center for Independent Experts ( www.ciereviews.org ) will review the model methods, input data and parameters, including the adequacy of the model and model outputs, and suggest research priorities to improve understanding of essential population and fishery dynamics necessary to formulate best management practices. The MSY estimates generated by the model will be the foundation upon which the Council and NMFS will base management decisions for Pacific Island coral reef fisheries, including establishment of annual catch limits (ACL) starting in 2015.

The Council and NMFS established the WPSAR process pursuant to Section 302(g)(1)(E), which provides that the Secretary of Commerce and each regional fishery management council may establish a peer review process for scientific information used to advise the Council about fisheries conservation and management. The Council and NMFS emphasize constituent and stakeholder participation in the WPSAR process and ensuring rigorous and independent review of information.

Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. 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.

This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Kitty M. Simonds, (808) 522-8220 (voice) or (808) 522-8226 (fax), at least 5 days prior to the meeting date.

The MAFMC's Summer Flounder, Scup, and Black Sea Bass Advisory Panel will meet jointly with the Atlantic States Marine Fisheries Commission's Summer Flounder, Scup, and Black Sea Bass Advisory Panels. This meeting has two primary purposes, as described below:

1. The AP will review fishery performance and create AP Fishery Performance Reports for Summer Flounder, Scup, and Black Sea Bass. Specifications for the 2015 fishing year, including catch and landings limits and commercial management measures, have already been implemented as part of previously set multi-year specifications. Specifications for 2015 will be reviewed by the MAFMC and Atlantic States Marine Fisheries Commission (ASFMC) to determine whether any changes are warranted. The Advisory Panel's Fishery Performance Reports for each species will be provided to the MAFMC and the ASMFC prior to their review of 2015 specifications.

2. The AP will be asked to provide input on the range of issues to be considered in a recently-initiated amendment to the MAFMC's Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan. This amendment will relate to summer flounder management goals and strategies. More information can be found at: http://www.mafmc.org/actions/summer-flounder-amendment/ .

Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. 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 MAFMC's intent to take final action to address the emergency.

The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to M. Jan Saunders at the Mid-Atlantic Council Office, (302) 526-5251, at least 5 days prior to the meeting date.

On 3/28/2014 (79 FR 17509-17510) and 4/11/2014 (79 FR 20190-20191), the Committee for Purchase From People Who Are Blind or Severely Disabled published notices of proposed additions to the Procurement List.

After consideration of the material presented to it concerning capability of qualified nonprofit agencies to provide the products and impact of the additions on the current or most recent contractors, the Committee has determined that the products listed below are suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.

I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:

1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will furnish the products to the Government.

2. The action will result in authorizing small entities to furnish the products to the Government.

3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the products proposed for addition to the Procurement List.

Accordingly, the following products are added to the Procurement List:

This notice is published pursuant to 41 U.S.C. 8503(a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.

If the Committee approves the proposed additions, the entities of the Federal Government identified in this notice will be required to procure the products and services listed below from nonprofit agencies employing persons who are blind or have other severe disabilities.

The following products and services are proposed for addition to the Procurement List for production by the nonprofit agencies listed:

The following product is proposed for deletion from the Procurement List:

The OMB is particularly interested in comments which:

• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of CNCS, including whether the information will have practical utility;

• 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;

• Propose ways to enhance the quality, utility, and clarity of the information to be collected; and

• Propose ways to 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.

A 60-day Notice requesting public comment was published in the Federal Register on 28 March 2014. This comment period ended May 27, 2014. No public comments were received from this Notice.

Description: CNCS is seeking approval of NCCC Team Leader Application, which was developed to collect applicant information for the hiring of NCCC Team Leaders at each of the five NCCC campuses. The application will be completed by prospective NCCC Team Leaders, during each campus hire cycle. Completion of this information collection is required to be selected as an NCCC Team Leader.

Type of Review: Renewal.

Agency: Corporation for National and Community Service.

Title: NCCC Team Leader Application.

OMB Number: 3045-0005.

Agency Number: None.

Affected Public: AmeriCorps NCCC Team Leader applicants.

Total Respondents: 800.

Frequency: Bi-annual application.

Average Time per Response: Averages 2 hours.

Estimated Total Burden Hours: 1,600 hours.

Total Burden Cost (capital/startup): None.

Total Burden Cost (operating/maintenance): None.

Title, Associated Form, and OMB Number: Defense Federal Acquisition Regulation Supplement (DFARS), Part 251, Contractor Use of Government Supply Sources, and an associated clause at DFARS 252.251-7000, Ordering from Government Supply Sources; OMB Control Number 0704-0252.

Needs and Uses: This information collection permits contractors to place orders from Government supply sources, including Federal Supply Schedules, requirements contracts, and Government stock. The information submitted enables DoD to evaluate whether a contractor is authorized to place such orders.

Affected Public: Businesses or other for-profit and not-for-profit institutions.

Annual Burden Hours: 5,250.

Number of Respondents: 3,500.

Responses per Respondent: 3.

Annual Responses: 10,500.

Average Burden per Response: Approximately 30 minutes.

Frequency: On occasion.

This information collection includes requirements relating to DFARS part 251, Contractor Use of Government Supply Sources. The clause at DFARS 252.251-7000, Ordering from Government Supply Sources, requires a contractor to provide a copy of an authorization when placing an order under a Federal Supply Schedule, a Personal Property Rehabilitation Price Schedule, or an Enterprise Software Agreement.

On March 12, 2014, we published in the Federal Register (79 FR 14012) a notice inviting applications for the Elementary and Secondary School Counseling Programs grant competition. That notice established an April 28, 2014, deadline for submitting an application. For prospective applicants who were adversely affected by severe weather in Alabama, Arkansas, Florida, and Mississippi on April 27, 2014, we are extending the deadline so that they have sufficient time to submit an application. The extension of the application deadline date in this notice applies to eligible applicants under the Elementary and Secondary School Counseling Programs grant competition that are located in a designated area covered by a Presidential Federal Disaster Declaration, and which had an incident period that included April 27-28, 2014, as determined by the Federal Emergency Management Agency (FEMA) (see www.fema.gov/news/disasters.fema ). Information on the designated areas in each of four affected States can be found at the following links: Alabama ( http://www.fema.gov/disaster/4176 ); Arkansas ( http://www.fema.gov/disaster/4174 ); Florida ( http://www.fema.gov/disaster/4177 ); and, Mississippi ( http://www.fema.gov/disaster/4175 ). We will not accept applications from applicants who were not located in this federally declared disaster area during April 27-28, 2014.

Applicants under this competition are required to use Grants.gov to submit their application. The Department extends the deadline date for this competition to June 16, 2014 so that prospective applicants affected by severe weather will have additional time to submit an application. As a result of the change in the deadline date, we are also extending the deadline date for intergovernmental review only for these prospective applicants to August 15, 2014.

All information in the March 12, 2014, notice for this competition remains the same, except for the change in the deadline for submitting applications and the deadline for intergovernmental review.

Accessible Format: Individuals with disabilities can obtain this document and a copy of the application package in an accessible format (e.g., braille, large print, audiotape, or compact disc) on request to the program contact person listed under FOR FURTHER INFORMATION CONTACT .

Electronic Access to This Document: The official version of this document is the document published in the Federal Register . Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.gpo.gov/fdsys . At this site you can view this document, as well as all other documents of this Department published in the Federal Register , in text or Adobe Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov . Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

Pursuant to Section 6(f) of the Federal Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing 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 June 9, 2014), on the World Wide Web, at http://www.ftc.gov/os/actions.shtm.

You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before July 9, 2014. Write “I-Health, Inc. and Martek Biosciences Corporation—Consent Agreement; File No. 122 3067” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at http://www.ftc.gov/os/publiccomments.shtm. As a matter of discretion, the Commission tries to remove individuals' home contact information from comments before placing them on the Commission Web site.

Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, like anyone's Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, like medical records or other individually identifiable health information. In addition, do not include any “[t]rade secret or any commercial or financial information which . . . is privileged or confidential,” as discussed in Section 6(f) of the FTC Act, 15 U.S.C. § 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not include competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.

If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you have to follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c). 1 Your comment will be kept confidential only if the FTC General Counsel, in his or her sole discretion, grants your request in accordance with the law and the public interest.

Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at https://ftcpublic.commentworks.com/ftc/ihealthconsent by following the instructions on the web-based form. If this Notice appears at http://www.regulations.gov/#!home, you also may file a comment through that Web site.

If you file your comment on paper, write “I-Health, Inc. and Martek Biosciences Corporation—Consent Agreement; File No. 122 3067” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex D), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex D), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.

Visit the Commission Web site at http://www.ftc.gov to read this Notice and the news release describing it. The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before July 9, 2014. You can find more information, including routine uses permitted by the Privacy Act, in the Commission's privacy policy, at http://www.ftc.gov/ftc/privacy.htm.

The Federal Trade Commission (“FTC” or “Commission”) has accepted, subject to final approval, an agreement containing a consent order from against i-Health, Inc. and Martek Biosciences Corporation (hereafter “the companies”).

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 or make final the agreement's proposed order.

This matter involves the companies' advertising for the BrainStrong Adult dietary supplement containing algal docosahexaenoic acid (“DHA”), an omega-3 fatty acid. The Commission's complaint alleges that, based primarily on a randomized, controlled trial called the “Memory Improvement with Docosahexaenoic Acid (DHA) Study” (the “MIDAS study”), the companies advertised that BrainStrong Adult improves memory and prevents cognitive decline in adults, and is clinically proven to improve memory in adults. Human cognitive function consists of at least five different types of memory, as well as non-memory abilities such as executive function, attention, processing speed, and reasoning. The MIDAS study objectively tested only two types of memory (episodic and working memory) and the cognitive ability of executive function, and was not designed to test DHA's effect on cognitive decline in aging adults.

The complaint alleges that the companies violated Sections 5(a) and 12 of the Federal Trade Commission Act by making the unsubstantiated representation that BrainStrong Adult improves memory in adults. According to the complaint, the MIDAS study did not show that BrainStrong Adult improves working memory or the cognitive ability of executive function. In addition, results from the tests of episodic memory did not yield a pattern of statistically and clinically significant improvement in the DHA group relative to the placebo group. For the same reasons, the complaint also alleges that the companies violated Sections 5(a) and 12 by making the false or misleading representation that BrainStrong Adult is clinically proven to improve memory in adults.

Finally, the complaint alleges that the companies violated Sections 5(a) and 12 by making the unsubstantiated representation that BrainStrong Adult prevents cognitive decline in adults. According to the complaint, a subject's performance on laboratory tasks that measure only one type of memory ( i.e., episodic) does not fully capture the overall state of his or her cognitive function, which includes other types of memory and non-memory cognitive abilities. In the MIDAS study, subjects treated with DHA for twenty-four weeks performed worse than placebo on a task of executive function, a non-memory cognitive ability. Moreover, a twenty-four-week study is an insufficient duration to test the impact of DHA on cognitive decline. Because the placebo group in the MIDAS study showed no evidence of cognitive decline, the study could reach no conclusion about DHA's ability to prevent or slow that condition.

The proposed order includes injunctive relief that prohibits these alleged violations and fences in similar and related violations. For purposes of the order, “Covered Product” means any dietary supplement, food, or drug promoted to prevent cognitive decline or improve memory, or containing DHA, including, but not limited to, BrainStrong Adult, except for infant formula or ingredients when sold specifically for use in infant formula. As additional fencing-in relief, the order requires the companies to follow appropriate recordkeeping and compliance reporting requirements, as well as document preservation requirements for human clinical studies that they conduct or sponsor on the Covered Product.

Part I of the proposed order prohibits any representation that the Covered Product improves memory or prevents cognitive decline in adults, unless it is non-misleading and supported by competent and reliable scientific evidence. Such evidence must consist of human clinical testing that is sufficient in quality and quantity, based on standards generally accepted by experts in cognitive science, when considered in light of the entire body of relevant and reliable scientific evidence, to substantiate that the representation is true. The testing must have been conducted by qualified researchers, and have been randomized, double-blind, and placebo-controlled. In addition, the companies must maintain all underlying or supporting data that cognitive science experts generally would accept as relevant to an assessment of such testing.

Part II of the proposed order prohibits any representation about the health benefits, performance, safety, or efficacy of the Covered Product, unless it is non-misleading and supported by competent and reliable scientific evidence that is sufficient in quality and quantity based on standards generally accepted in the relevant scientific fields, when considered in light of the entire body of relevant and reliable scientific evidence, to substantiate that the representation is true. For purposes of this Part, competent and reliable scientific evidence means tests, analyses, research, or studies that have been conducted by a qualified person in an objective manner and are generally accepted in the profession to yield accurate and reliable results. When that evidence consists of a human clinical trial, the companies must maintain all underlying or supporting data and documents that experts in the field generally would accept as relevant to an assessment of such testing.

Part III of the proposed order prohibits the companies from misrepresenting, including through the use of a product name, word or phrase such as “clinically shown” or “clinically proven,” endorsement, depiction, illustration, trademark, or trade name, the existence, contents, validity, results, conclusions, or interpretations of any test, study, or research, including misrepresenting that the benefits of the product are clinically proven or that the product is clinically proven to improve memory in adults.

Part IV of the proposed order provides a safe harbor for representations permitted under any tentative or final standard promulgated by the Food and Drug Administration (“FDA”), any new drug application approved by the FDA, or FDA regulations pursuant to the Nutrition Labeling and Education Act of 1990 or the FDA Modernization Act of 1997.

Part V contains recordkeeping requirements for advertisements and substantiation relevant to representations covered by Parts I through III of the order.

Triggered when the human clinical testing requirement in either Part I or II applies, Part VI of the proposed order requires the companies to secure and preserve all underlying or supporting data and documents generally accepted by experts in the field as relevant to an assessment of the test, such as protocols, instructions, participant-specific data, statistical analyses, and contracts with the test's researchers. There is an exception for a “Reliably Reported” test defined as a test published in a peer-reviewed journal that was not conducted, controlled, or sponsored by any proposed respondent or supplier. Also, the published report must provide sufficient information about the test for experts in the relevant field to assess the reliability of the results.

Parts VII through IX of the proposed order require the companies to: deliver a copy of the order to officers, employees, and representatives having managerial responsibilities with respect to the subject matter of the order; notify the Commission of changes in corporate structure that might affect compliance obligations under the order; and file compliance reports with the Commission.

Part X 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 complaint or proposed order, or to modify the proposed order's terms in any way.

We write to explain our support for the complaint and order imposed against respondents i-Health, Inc. and Martek Biosciences Corporation (collectively, “i-Health”) with respect to advertising claims that their BrainStrong Adult dietary supplement improves adult memory and is clinically proven to do so. Section 5 of the FTC Act requires that advertisers have a reasonable basis for the claims they make to ensure that their claims are truthful and non-deceptive. 1 We have reason to believe that i-Health fell short of this standard.

i-Health advertises a dietary supplement, BrainStrong Adult, containing docosahexaenoic acid (“DHA”), with broad and prominent claims that the product is “[c]linically shown to improve memory.” Its advertising also makes the general efficacy claim that BrainStrong improves memory. Consumers would likely have reasonably interpreted these claims broadly to include a wide variety of promises of real-life improvements in memory, such as the ability to remember the location of one's sunglasses or why one entered a room—which is the precise scenario depicted in i-Health's television ad. 2 We do not believe that i-Health possessed the evidence necessary to back up such reasonable interpretations by consumers. Accordingly, we allege that i-Health's efficacy claim was unsubstantiated and that its establishment claim was false and misleading. 3

i-Health's establishment claim that BrainStrong Adult is clinically proven to improve adult memory requires, by its own terms, a well-controlled human clinical study. 4 Its efficacy claim about its dietary supplement must be supported by competent and reliable scientific evidence. 5 In support of these claims, i-Health relies primarily on a double-blind, placebo-controlled clinical study published in a peer-reviewed journal—the Memory Improvement with Docosahexaenoic Acid Study (“MIDAS study”). The study purports to show that DHA “improves episodic memory” and “memory function.” The MIDAS study's principal investigator and author was an employee of respondent Martek. 6

As an initial matter, regardless of the methodology and purported findings of the MIDAS study, the first question we ask is what the study was designed to measure and demonstrate. Stated differently, and more directly for our purposes, does the study, assuming it was well-conducted, substantiate i-Health's broad claims that BrainStrong improves memory and that it was “clinically shown” to do so? Contrary to the view of Commissioner Ohlhausen, we do not think it does.

As detailed in the complaint, there are several types of human memory, including episodic memory, sensory memory, working memory, semantic memory, and procedural memory. Importantly, the MIDAS study tested tasks associated with only two types of memory: episodic memory, the recollection of specific personal events linked to a time and place, such as where someone left her car keys; and working memory, the short-term mental manipulation of information, such as the ability to follow a story or discussion. Notably, the study reports only a very small improvement from BrainStrong in relation to episodic memory—the positive result was essentially limited to performance on a single test of one of three types of episodic memory that were measured (visuospatial). The study did not reveal any improvement in working memory. In light of the narrow scope of the study and its limited results, we have reason to believe that i-Health's marketing claims that BrainStrong improves “memory” broadly speaking would likely mislead consumers, as there is no basis to conclude that it has any impact whatsoever on other important facets of memory, such as the ability to remember the meaning of words (semantic memory) or to follow an exchange of dialogue (working memory). This alone would be reason enough for us to conclude that the MIDAS study does not adequately substantiate i-Health's general memory improvement claims.

But our concerns extend even further. As we have also alleged in the complaint, the MIDAS study did not show a pattern of statistically and clinically significant improvements on the episodic memory tasks among subjects who took BrainStrong's DHA, relative to the placebo group. Specifically, it failed to show meaningful, statistically significant improvements on two of the three episodic memory tasks measured. Further, it failed to demonstrate that the very small, statistically significant improvement on one of those tasks that it did report correlates with improvements in memory tasks outside of the laboratory. 7 We believe that reasonable consumers would likely be misled that BrainStrong will result in the kinds of real-life improvements depicted in i-Health's advertising.

It is correct, as Commissioner Ohlhausen notes in her dissent, that some of the statements made by the study's authors in the “Results” and “Discussion” sections of the MIDAS study use language similar to that in i-Health's memory improvement claims. However, we disagree that the Commission must accept at face value these statements as supportive of the claims in i-Health's advertising. Doing so would be inconsistent with the Commission's obligation to assess the quality and reliability of the scientific evidence underlying challenged advertising claims. 8 Our conclusions are based on extensive consultations with experts in the cognitive science and biostatistics fields. Consistent with the requirements of Section 5 and our past practice, 9 we undertook an evaluation of the results of the MIDAS study to assess whether they substantiated i-Health's advertising claims and did not simply defer to the authors' interpretations of their results. 10

For all of the foregoing reasons, we have reason to believe that i-Health lacked adequate substantiation for the broad marketing claims that BrainStrong Adult improves adult memory, that i-Health's clinical-proof claims are false and misleading, and that the relief set forth in the proposed order is appropriate.

The Commission has long interpreted Section 5 of the FTC Act 1 to require an advertiser to have a reasonable basis for making an objective claim about its product. 2 As we execute this mandate, we must be mindful of what we are trying to accomplish, however. As former FTC Chairman Robert Pitofsky stated, the overall goal of evaluating advertising claims is not “a broad, theoretical effort to achieve Truth, but rather a practical enterprise to ensure the existence of reliable data which in turn will facilitate an efficient and reliable competitive market process.” 3

I dissent in part from today's action because it imposes an unduly high standard of substantiation on a safe product. This unduly high standard not only risks denying consumers useful information in the present but may also, in the long term, diminish incentives to conduct research on the health effects of foods and dietary supplements and reduce the incentives of manufacturers to introduce such products. 4 The majority's approach may ultimately undermine an efficient and reliable competitive market process and make consumers worse off. 5

The complaint in this matter challenges the efficacy claim that BrainStrong Adult (a DHA supplement) improves memory in adults and the establishment claim that BrainStrong Adult is clinically proven to improve memory in adults. 6 Advertisers must support claims of efficacy of dietary supplements with “competent and reliable scientific evidence.” 7 For establishment claims, where advertisements refer to a certain level of support, advertisers “must be able to demonstrate that the assertion is accurate [and] have the level of support that they claim, expressly or by implication, to have.” 8

In this matter, the defendant offers as the primary substantiation for its claims the MIDAS study, a placebo-controlled, randomized, double-blind, parallel, multi-center, six-month, peer-reviewed, journal-published study of 485 subjects with statistically significant results. 9 Specifically, the MIDAS study concluded:

• “This clinical study demonstrated that 900 mg/d of DHA supplementation improved episodic memory and learning in healthy, older adults with mild memory complaints. . . . The DHA effects are significant in that they represent an objective demonstration of improved memory in [age-related cognitive decline].” 10

• “Our results are the first to clinically confirm that DHA significantly improves episodic memory and learning functions in healthy adults with [age-related cognitive decline].” 11

• “Our study results demonstrate that DHA is well tolerated and may have significant positive effect on gradual memory loss. . . .” 12

These conclusions match up well with the “improves memory” efficacy claim and the “clinically proven to improve memory” establishment claim. 13 Thus, I believe this study, in the context of other supporting studies involving DHA and memory, 14 provides a reasonable basis for the “improves memory” claims. 15

The complaint offers two reasons why the MIDAS study, despite being well-conducted and having statistically significant results, does not substantiate Martek's claims for BrainStrong Adult. First, the complaint argues that the “improves memory” claim is unsubstantiated because the MIDAS study did not show that BrainStrong Adult improved performance for all types of memory. However, the MIDAS study did demonstrate a statistically significant improvement in performance on episodic memory tasks. An improvement in episodic memory is indeed an improvement in memory, and the claim accurately conveys the study's findings in consumer vernacular.

Second, instead of criticizing the study's methodology, the complaint criticizes its conclusions. The complaint asserts that the MIDAS study “did not yield a pattern of statistically and clinically significant improvement” in memory. 16 This conclusion is based on the opinion of experts retained by FTC staff. The eight MIDAS study co-authors clearly disagree with this conclusion, as demonstrated by their own conclusions in the study.

The fact that some experts may disagree with the conclusions of a well-conducted study does not render that study unreliable or incompetent, nor make claims based on the study unsubstantiated. Specifically, Martek's reliance upon the MIDAS study, which was both well-conducted and consistent with other research, is not rendered unreasonable by the existence of some disagreement among experts. Indeed, “some disagreement” is the usual state of science. 17

As set forth in the Commission's complaint, i-Health, Inc. and Martek Biosciences Corporation (i-Health) marketed a dietary supplement branded as BrainStrong Adult, which contains docosahexaenoic acid (DHA). In its advertising and marketing, i-Health represented, among other things, that BrainStrong Adult improves memory in adults. 1

As articulated in the complaint, these representations included a general memory improvement claim as well as a specific “episodic” memory improvement claim. I write separately to explain why, in my view, the Memory Improvement with Docosahexaenoic Acid Study (the MIDAS study) does not provide evidence sufficient to substantiate either of those claims.

First, the MIDAS study was not designed to evaluate all the types of memory that would be encompassed within a general memory claim. 2 As set forth in the complaint, there are several types of human memory, including episodic, sensory, working, semantic, and procedural. Although the MIDAS study included one test of working memory, which found no benefit from supplementation, the study's focus was episodic memory. Therefore, to the extent that consumers took away an understanding that BrainStrong Adult would improve general memory, rather than a single dimension of human memory, that claim was unsubstantiated.

Second, the MIDAS study does not adequately substantiate even a narrower claim of improving episodic memory—for example, that BrainStrong Adult would help consumers recall where they had just left their keys or the reason they left one room to walk into another room. It is correct the MIDAS study was a well-designed attempt to evaluate improvement in episodic memory. 3 The shortcoming of the MIDAS study as it relates to substantiation is not study design or methodology but rather that, put simply, its results were inconsistent and insufficiently robust to support claims about noticeable improvement in everyday memory along the lines of the television ad.

Episodic memory is a cognitive construct that encompasses the ability to recall specific autobiographical or personal events or “episodes,” as well as the time and place those events occurred. Episodic memories have one or more components (e.g., visual, visuospatial, verbal, auditory, and temporal) and are formed in the brain's hippocampus after it interacts with one or more other brain regions. Identifying and isolating episodic memory can be especially difficult because of the potential influence of interactions with other brain regions, which may make it difficult to know whether and to what extent an improvement in test performance was due to changes to hippocampal function.

Consequently, in order to assess changes in episodic memory, cognitive experts generally conduct studies employing multiple measures of episodic memory. Laboratory tests of episodic memory probe hippocampal function via different modalities (e.g., visual, auditory, verbal, and tactile) and cognitive tasks (pattern recognition, visuospatial memory, verbal recall). Cognitive experts then consider the results of the different tests together, which reduces the impact of the various confounding influences that are associated with each individual test. This standard approach reduces the likelihood that idiosyncrasies in the design or administration of any one test will lead to an erroneous conclusion. 4

Importantly, cognitive experts would generally accept that the observed effects from the intervention under study reflect changes to episodic memory rather than the influence of other neural pathways or a spurious correlation, when the multiple measures show a consistent trend in favor of treatment. By contrast, cognitive experts evaluating an intervention that generates a small but statistically significant effect for one task but not the other two would generally conclude the collective results are insufficient to demonstrate improved episodic memory.

The MIDAS study properly employed three types of laboratory tasks to test different, but interrelated, aspects of episodic memory—visuospatial memory, visual pattern recognition memory, and visual-verbal memory. 5 However, because the results of the three laboratory tasks, when evaluated together, did not consistently trend in support of improved episodic memory, the MIDAS study is not sufficient to substantiate i-Health's improved episodic memory claim.

This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES ).

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

1. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Fast Track Appeals Notices: NOMNC/DENC; Use: Providers shall deliver a Notice of Medicare (Provider) Non-Coverage (NOMNC) to beneficiaries/enrollees no later than two days prior to the end of Medicare-covered services in skilled nursing facilities, home health agencies, comprehensive outpatient rehabilitation facilities, and hospices. Beneficiaries, enrollees or both beneficiaries and enrollees will use this information to determine whether they want to appeal the service termination to their Quality Improvement Organization (QIO). If the beneficiaries, enrollees or both beneficiaries decide to appeal, the Medicare provider or health plan will send the QIO and appellant a Detailed Explanation of Non-Coverage (DENC) detailing the rationale for the termination decision.

Form Number: CMS-10123 and 10124 (OMB control number: 0938-0910); Frequency: Occasionally; Affected Public: Private sector—Business or other for-profits and Not-for-profit institutions; Number of Respondents: 24,915; Total Annual Responses: 5,347,980; Total Annual Hours: 927,901. (For policy questions regarding this collection contact Janet Miller at 404-562-1799.)

2. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Medicare Prescription Drug Coverage and Your Rights; Use: Through the delivery of this standardized notice, Part D plan sponsors' network pharmacies are in the best position to inform enrollees (at the point of sale) about how to contact their Part D plan if their prescription cannot be filled and how to request an exception to the Part D plan's formulary. The notice restates certain rights and protections related to the enrollees Medicare prescription drug benefits, including the right to receive a written explanation from the drug plan about why a prescription drug is not covered.

Form Number: CMS-10147 (OMB control number: 0938-0975); Frequency: Occasionally; Affected Public: Private sector—Business or other for-profits; Number of Respondents: 56,000; Total Annual Responses: 37,620,000; Total Annual Hours: 626,749. (For policy questions regarding this collection contact Kathryn M. Smith at 410-786-7623.)

3. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Data Use Agreement (DUA) Certificate of Disposition (COD) for Data Acquired from the Centers for Medicare & Medicaid Services; Use: The Data Use Agreement (DUA) Certificate of Disposition (COD) is required to close out the release of the data under the DUA and to ensure the data are destroyed and not used for another purpose without written authorization from CMS. The Health Insurance Portability and Accountability Act (HIPAA) of 1996, § 1173(d) (Security Standards for Health Information) requires CMS to protect Personally Identifiable Information (PII). Additionally, the Federal Information Security Management Act (FISMA) of 2002, § 3544(b) (Federal Agency Responsibilities—Agency Program) also requires CMS to develop policies and procedures for the protection and destruction of sensitive data to include PII.

Form Number: CMS-10252 (OMB control number: 0938-1046); Frequency: Biennial; Affected Public: Private Sector—Business or other for-profits and Not-for-profit institutions; Number of Respondents: 500; Total Annual Responses: 1,000; Total Annual Hours: 84. (For policy questions regarding this collection contact Sharon Kavanagh at 410-786-5441.)

4. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Medicare Part C and Part D Data Validation; Use: Organizations contracted to offer Medicare Part C and Part D benefits are required to report data to us on a variety of measures. For the data to be useful for monitoring and performance measurement, the data must be reliable, valid, complete, and comparable among sponsoring organizations. To meet this goal, we have developed reporting standards and data validation specifications with respect to the Part C and Part D reporting requirements. These standards provide a review process for Medicare Advantage Organizations, Cost Plans, and Part D sponsors to use to conduct data validation checks on their reported Part C and Part D data. The currently approved information collection is being revised to reflect decreases in the number of reporting sections being validated and an increase in the average number of data elements per reporting section for 2015-2017.

Form Number: CMS-10305 (OMB control number: 0938-1115); Frequency: Yearly; Affected Public: Private sector—Business or other for-profits; Number of Respondents: 706; Total Annual Responses: 706; Total Annual Hours: 202,578. (For policy questions regarding this collection contact Terry Lied at 410-786-8973.)

5. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Survey Tool for www.medicare.gov and www.cms.hhs.gov ; Use: The Balanced Budget Act of 1997 states that the Secretary of Health and Human Services shall maintain a Web site to provide information about CMS activities, programs and topics related to its services. The present request is for OMB authorization to collect data on the reactions of users of the Web sites through the survey tool. We will use the data to improve the Web sites so that they can best serve the needs of their users. Information collected from the survey will be used to make improvements to the sites to make them more user friendly.

Form Number: CMS-R-268 (OMB control number: 0938-0756); Frequency: Annual; Affected Public: Individuals or households; Number of Respondents: 7,000; Total Annual Responses: 4,900; Total Annual Hours: 817. (For policy questions regarding this collection contact Kymeiria Ingram at 410-786-8431.)

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment:

1. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Disclosure for the In-Office Ancillary Services Exception; Use: Physicians who provide certain imaging services (magnetic resonance imaging, computed tomography, and positron emission tomography) under the in-office ancillary services exception to the physician self-referral prohibition are required to create the disclosure notice as well as the list of other imaging suppliers to be provided to the patient. The patient can use the disclosure notice and list of suppliers in making an informed-decision about his or her course of care for the imaging service. The physician must maintain a record of the disclosure in the patient's medical record. If we were investigating the referrals of a physician providing advanced imaging services under the in-office ancillary services exception, we would review the written disclosure to determine whether the physician satisfied the requirement.

Form Number: CMS-10332 (OMB control number: 0938-1133); Frequency: Occasionally; Affected Public: Private sector—Business or other for-profits; Number of Respondents: 71,000; Total Annual Responses: 71,106; Total Annual Hours: 125,383. (For policy questions regarding this collection contact Jacqueline Proctor at 410-786-8852.)

We encourage you to participate in this application for recertification by submitting comments and related materials. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided.

If you submit a comment, please include the docket number for this notice of availability (USCG-2014-0414), indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online (via http://www.regulations.gov ) or by fax, mail, or hand delivery, but please use only one of these means. If you submit a comment online via 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 Docket Management Facility. We recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.

To submit your comment online, go to http://www.regulations.gov, click on the “submit a comment” box, which will then become highlighted in blue. In the “Document Type” drop down menu select “Proposed Rule” and insert “USCG-2014-0414” in the “Keyword” box. Click “Search” then click on the balloon shape in the “Actions” column. If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8.5 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 may withhold recertification or grant a conditional recertification based on your comments.

To view comments, as well as documents mentioned in this preamble 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-2014-0414” and click “Search.” Click the “Open Docket Folder” in the “Actions” column. You may also visit the Docket Management Facility in Room W12-140 on the ground floor of the Department of Transportation West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. We have an agreement with the Department of Transportation to use the Docket Management Facility.

Anyone can search the electronic form of comments received into any of our 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 notice regarding our public dockets in the January 17, 2008, issue of the Federal Register (73 FR 3316).

The Coast Guard does not plan to hold a public meeting. But you may submit a request for one on or before July 16th, 2014 using one of the four methods specified under ADDRESSES . Please explain why you believe a public meeting would be beneficial. If we determine that one would aid the process of thoroughly considering the application for recertification, we will hold one at a time and place announced by a later notice in the Federal Register .

The Coast Guard published guidelines on December 31, 1992 (57 FR 62600), to assist groups seeking recertification under the Oil Terminal and Oil Tanker Environmental Oversight and Monitoring Act of 1990 (33 U.S.C. 2732) (the Act). The Coast Guard issued a policy statement on July 7, 1993 (58 FR 36504), to clarify the factors that the Coast Guard would be considering in making its determination as to whether advisory groups should be certified in accordance with the Act; and the procedures which the Coast Guard would follow in meeting its certification responsibilities under the Act. Most recently, on September 16, 2002 (67 FR 58440), the Coast Guard changed its policy on recertification procedures for regional citizen's advisory council by requiring applicants to provide comprehensive information every three years. For the two years in between, applicants only submit information describing substantive changes to the information provided at the last triennial recertification. This is the year in this triennial cycle that CIRCAC must provide comprehensive information.

At the conclusion of the comment period, July 16, 2014, the Coast Guard will review all application materials and comments received and will take one of the following actions:

(a) Recertify the advisory group under 33 U.S.C. 2732(o).

(b) Issue a conditional recertification for a period of 90 days, with a statement of any discrepancies, which must be corrected to qualify for recertification for the remainder of the year.

(c) Deny recertification of the advisory group if the Coast Guard finds that the group is not broadly representative of the interests and communities in the area or is not adequately fostering the goals and purposes of 33 U.S.C. 2732.

The Coast Guard will notify CIRCAC by letter of the action taken on their respective applications. A notice will be published in the Federal Register to advise the public of the Coast Guard's determination.

Section 416 of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, (Pub. L. 93-288, as amended) (“Stafford Act”), authorizes the President to provide financial assistance to States, U.S. Territories, and Federally recognized Indian Tribal governments for professional counseling services to survivors of major disasters to relieve mental health problems caused or aggravated by a major disaster or its aftermath. FEMA has codified Section 416 of the Stafford Act at section 44 CFR 206.171 entitled Crisis Counseling Assistance and Training. Under Section 416 of the Stafford Act and 44 CFR 206.171, the President has designated the Department of Health and Human Services-Center for Mental Health Services (HHS-CMHS) to coordinate with FEMA in administering the Crisis Counseling Assistance and Training Program (CCP). FEMA and HHS-CMHS signed an interagency agreement under which HHS-CMHS provides program oversight, technical assistance and training to States applying for CCP funding.

Title: Crisis Counseling Assistance and Training Program.

Type of Information Collection: Revision of a currently approved information collection.

OMB Number: 1660-0085.

FEMA Forms: FEMA Form 003-0-1, Crisis Counseling Assistance and Training Program, Immediate Services Program Application; FEMA Form 003-0-2, Crisis Counseling Assistance and Training Program, Regular Services Program Application; SF-424, Application for Federal Assistance; SF-424A, Budget Information for Non-Construction Programs; SF-425, Federal Financial Report; HHS Checklist/08- 2007; HHS Project Performance Site Location Form.

Abstract: The CCP consists of two grant programs, the Immediate Services Program (ISP) and the Regular Services Program (RSP). The ISP and the RSP provide supplemental funding to States, U.S. Territories, and Federally recognized Tribes following a Presidentially-declared disaster. The grant programs provide funding for Training and Services, including community outreach, public education, and counseling techniques. States are required to submit an application that provides information on Needs Assessment, Plan of Service, Program Management, and an accompanying Budget.

Number of Respondents: 150.

Number of Responses: 165.

Estimated Total Annual Burden Hours: 1,515 hours.

Estimated Cost: The estimated annual cost to respondents for the hour burden is $84,476.40. There are no annual costs to respondents operations and maintenance costs for technical services. There is no annual start-up or capital costs. The cost to the Federal Government is $107,717.

Comments may be submitted as indicated in the ADDRESSES caption above. Comments are solicited to (a) evaluate whether the proposed data collection is necessary for the proper performance of the agency, including whether the information shall have practical utility; (b) 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; (c) enhance the quality, utility, and clarity of the information to be collected; and (d) 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, e.g., permitting electronic submission of responses.

The Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the new or modified flood hazard information for each community listed. Notification of these changes has been published in newspapers of local circulation and ninety (90) days have elapsed since that publication. The Deputy Associate Administrator for Mitigation has resolved any appeals resulting from this notification.

This final notice is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.

Interested lessees and owners of real property are encouraged to review the new or revised FIRM and FIS report available at the address cited below for each community or online through the FEMA Map Service Center at www.msc.fema.gov.

The flood hazard determinations are made final in the watersheds and/or communities listed in the table below.

In the final flood hazard determination notice published at 79 FR 15598 in the March 20, 2014, issue of the Federal Register , FEMA published tables titled “Poweshiek County, Iowa, and Incorporated Areas” and “Douglas County, Nebraska, and Incorporated Areas”. These tables contained inaccurate information as to the communities affected by the final flood hazard determinations for communities in Poweshiek County, Iowa, as well as Douglas County, Nebraska. Additionally, inaccurate community map repository address was published for the City of Montezuma, Iowa featured in the “Poweshiek County, Iowa, and Incorporated Areas” table. In this document, FEMA is publishing revised tables containing the accurate information. The information provided in the tables below should be used in lieu of that previously published.

The Federal Emergency Management Agency (FEMA) makes the final flood hazard determinations as shown in the LOMRs for each community listed in the table below. Notice of these modified flood hazard determinations has been published in newspapers of local circulation and ninety (90) days have elapsed since that publication. The Deputy Associate Administrator for Mitigation has resolved any appeals resulting from this notification.

The modified flood hazard determinations are made pursuant to section 206 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq., and with 44 CFR part 65.

For rating purposes, the currently effective community number is shown and must be used for all new policies and renewals.

The new or modified flood hazard information is the basis for the floodplain management measures that the community is required either to adopt or to show evidence of being already in effect in order to remain qualified for participation in the National Flood Insurance Program (NFIP).

This new or modified flood hazard information, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities.

This new or modified flood hazard determinations are used to meet the floodplain management requirements of the NFIP and also are used to calculate the appropriate flood insurance premium rates for new buildings, and for the contents in those buildings. The changes in flood hazard determinations are in accordance with 44 CFR 65.4.

Interested lessees and owners of real property are encouraged to review the final flood hazard information available at the address cited below for each community or online through the FEMA Map Service Center at www.msc.fema.gov.