Federal Register Vol. 80, No.55,

Title: Study on Nutrition and Wellness Quality in Childcare Settings (SNAQCS).

Form Number: N/A.

OMB Number: Not Yet Assigned.

Expiration Date: Not Yet Determined.

Type of Request: New Collection.

Abstract: Good nutrition is a key to proper childhood development, but not enough is known about the food children are eating in childcare and related programs. In 2011, 32.7 million children were in a regular childcare arrangement while their parents worked or pursued other activities outside of the home, according to the U.S. Census Bureau. In recognition of the importance of nutrition and physical activity in childcare, Congress directed the USDA to conduct a Study on Nutrition and Wellness Quality in Childcare Settings (SNAQCS) in Section 223 of the Healthy Hunger Free Kids Act (HHFKA) of 2010. The objectives set out by Congress encompass four broad topics: (1) Nutritional quality of foods offered, (2) physical activity, (3) sedentary activity, and (4) barriers to and facilitators of nutritional quality, physical activity, and participation by childcare centers and family day care homes in the Child and Adult Care Food Program (CACFP). For efficiency, USDA is coordinating the collection of other important variables with the section 223 data collection. The intent of the study is to document the quality of meals and snacks offered in childcare facilities, relative to the current Dietary Guidelines for Americans (DGA) which are prepared by USDA and the U.S. Department of Health and Human Services, and the types of activities that might promote or inhibit healthy weight and development. The study will also provide insights into how nutritional quality and physical activity in childcare might be improved. Lastly, the study will collect data on the costs of childcare meals and snacks in relationship to CACFP reimbursements, other funding, and meal quality.

The study will take place in the context of heightened concern about adequate nutrition, diet quality and obesity in young children. These concerns and developing knowledge about nutritional requirements for appropriate childhood growth, as reflected in the updated 2010 DGA, led the Institute of Medicine (IOM) Food and Nutrition Board to recommend new meal requirements for the CACFP in its 2010 report Child and Adult Care Food Program: Aligning Dietary Guidance for All. USDA recently published a proposed rule in the Federal Register to update the CACFP meal requirements based on these recommendations (January 15, 2015; 80 FR 2037). While USDA has not yet implemented new CACFP meal requirements, the IOM recommendations provide significant benchmarks for assessing current meal quality in the CACFP. Moreover, a comparison between current meal characteristics and the IOM recommendations suggests the extent of change that would be required to implement the IOM recommendations. The need for research to establish a baseline of current meal characteristics and quality in childcare settings is acknowledged in the IOM report, as are the challenges of technical assistance, monitoring, and cost that would come with the implementation of new meal requirements. The proposed study will directly address key research recommendations from the IOM report.

The study seeks to collect a broad range of data from a nationally representative sample which would include: (1) Sponsors, directors, food preparers and/or provider staff of childcare centers, family day care homes, and after-school programs that participate in the CACFP and those that do not participate in CACFP; and (2) children and parents of children receiving care from CACFP childcare centers, family day care homes, and after-school programs during 2015-2016. The sample is designed to provide required levels of statistical precision and data quality while minimizing data collection costs and respondent burden.

To address the study's three broad categories of research questions, the data collection activities to be undertaken subject to this notice will include the following surveys, forms, and interviews:

In addition, the study will include an Environmental Observation Form and a Meal Observation Form that will be completed by study staff and do not have any associated burden for study participants.

Affected Public: Respondent categories of affected public and the corresponding study participants will include: (a) Businesses (sample of childcare providers); and (b) individual/households (sample of children and their parents/guardians).

Estimated Number of Respondents: 12,472. The total proposed final number of unique respondents will include: (a) 3,753 sponsors, directors, food preparers and/or provider staff of childcare centers, family day care homes, and after-school childcare providers childcare that participate in the USDA Child and Adult Care Food Program (CACFP), and non-participating providers; (b) 3,000 children receiving care from CACFP childcare centers, family day care homes, and after-school programs; (c) 4,175 parents of children receiving care from CACFP childcare centers, family day care homes, and after-school childcare programs; and (d) 1,544 non-respondents.

Estimated Frequency of Responses per Respondent: 1.91 annually. All respondents will be asked to respond to or complete instruments as follows: (a) Sponsors will be asked to complete the Sponsor Pre-visit Cost Survey, the Sponsor Pre-visit Cost Form, and the Sponsor Cost Interview; (b) directors will be asked to complete the Provider Web Survey, the Center Director Pre-visit Cost Survey, the Center Director Cost Interview, and the Overhead & Equipment Cost Worksheet; (c) food preparers will be asked to complete the Menu Survey, the Reference Portion Measurement Form, the Table Waste Observation Form, and the Food Preparer Cost Interview; (d) provider staff will be asked to complete the Infant Food Intake Form; (e) children will be asked to cooperate with study staff who will weigh and measure them for the Standing Height and Weight Form; and (f) parents will be asked to complete a Parent Interview and the Child Food Diary for a childcare day, a non-childcare day, and a subsample will be asked to complete a third diary which could be either a childcare day or a non-childcare day. All respondents will be asked to respond to or complete each instrument only once with the exception of parents who will be asked to complete a Child Food Diary on 2-3 days.

Estimated Total Annual Responses: 23,767.

Estimated Time per Response: 35 minutes (0.59 hours). The estimated time of response varies from 4 minutes (0.07 hours) to 195 minutes (3.25 hours) depending on the respondent group, as shown in the table below. These estimates include time to read the initial materials as well as follow-up activities.

Estimated Total Annual Burden on Respondents: 13,945.99 hours. See the table below for estimated total annual burden for each type of respondent.

Pursuant to Section 14(a)(2)(A) of the Federal Advisory Committee Act (Pub. L. 92-463), and in accordance with Title 41 of the Code of Federal Regulations, section 102-3.65(a), and following consultation with the Committee Management Secretariat, General Services Administration, the RVAAC charter is renewed. The Committee will provide advice to the Access Board on revising and updating our accessibility guidelines issued pursuant to the Americans with Disabilities Act for transportation vehicles that operate on fixed guideway systems (e.g., rapid rail, light rail, commuter rail, intercity rail, and high speed rail). Additionally, the renewal of the RVAAC has been determined to be essential to the work of the Access Board and to be in the public interest in connection with the performance of duties required by law. The Committee will continue to operate in accordance with the provisions of the Federal Advisory Committee Act and the rules and regulations that implement that Act.

There will be six scoping meetings (each lasting approximately 1-2 hours depending on attendance) with the following dates/times/locations:

1. Monday, April 6, 2015, 4 p.m., Superior Trawl, 55 State Street, Narragansett, RI 02882; telephone: (401) 782-1171.

2. Tuesday, April 7, 2015, 5 p.m., Montauk Library, 871 Montauk Highway, Montauk, NY 11954; telephone: (631) 668-3377.

3. Wednesday, April 8, 2015, 5 p.m., Fairfield Inn, 185 MacArthur Dr., New Bedford, MA 02740; telephone: (774) 634-2000.

4. Monday, April 13, 2015, 6 p.m., Congress Hall Hotel. 251 Beach Ave, Cape May, NJ 08204, telephone: (888) 944-1816.

5. Wednesday, April 15, 2015, 5 p.m., Ocean Place Resort. 1 Ocean Blvd., Long Branch, NJ, 07740; telephone: 732-571-4000.

6. Tuesday, April 21, 2015, 6 p.m., This April 21, 2015 meeting will be conducted via webinar accessible via the internet from the Council's Web site, www.mafmc.org. The Virginia Marine Resources Commission will also provide in-person access to the webinar at its office at: 2600 Washington Avenue, 4th Floor, Newport News, VA 23607; telephone: (757) 247-2200. Members of the public may also attend in-person at the Council office address (see ADDRESSES) for this webinar meeting, if they contact the Council by April 19, 2015. Please contact Jason Didden by April 19, 2015 at [email protected] or (302) 526-5254 if you would like to test/confirm that your computer is set up to access the webinar.

In the Council's 2015 Implementation Plan (available at http://www.mafmc.org/strategic-plan/), the Council decided to initiate an action on a “Squid Capacity Amendment.” There is considerable latent capacity in both the longfin squid and Illex squid fisheries—a small portion of vessels with limited access squid permits account for most landings in most years. The Council is concerned that activation of this latent capacity could cause problems in the fishery such as racing to fish and increased incidental catch of non-target species. Accordingly, the Amendment is likely to consider a variety of approaches for reducing capacity in the squid fisheries. Such approaches could include, but would not be limited to, a requalification of limited access permits, a tiered limited access system, and/or a limited access privilege program (LAPP), which is more commonly referred to as an “individual quota” or “catch share system.” The Council has recently updated control dates for both squid fisheries—May 16, 2013 for longfin squid (http://www.greateratlantic.fisheries.noaa.gov/nr/2013/May/13smblongfinbutterfishcontroldatephl.pdf) and August 2, 2013 for Illex squid (http://www.greateratlantic.fisheries.noaa.gov/nr/2013/August/13smbillexcontroldatephl.pdf). The Council may (or may not) use the current or previous control dates as reference points as it considers whether, and/or how, to further limit the number of participants in the squid fisheries (see preceding links for additional details on the control dates).

The Council will first gather information during the scoping period. This is the first and best opportunity for members of the public to raise concerns related to the scope of issues that will be considered in the Amendment. The Council needs your input both to identify management issues and develop effective alternatives. Your comments early in the amendment development process will help us address issues of public concern in a thorough and appropriate manner. Comment topics could include the scope of issues in the amendment, concerns and potential alternatives related to capacity in the squid fisheries, and the appropriate level of environmental analysis. If the Council decides to move forward with the Amendment, the Council will develop a range of management alternatives to be considered and prepare a draft Environmental Impact Statement (DEIS) and/or other appropriate environmental analyses. These analyses will consider the impacts of the management alternatives being considered, as required by the National Environmental Policy Act (NEPA). Following a review of any comments on the draft analyses, the Council will then choose preferred management measures for submission with a Final EIS or Environmental Assessment to the Secretary of Commerce for publishing of a proposed and then final rule, both of which have additional comment periods. While the Council is conducting these scoping hearings, the Council will also accept general comments on the MSB fisheries. These general comments could inform Council decision making for upcoming annual specifications or other actions.

These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aid should be directed to M. Jan Saunders, (302) 526-5251, at least 5 days prior to the meeting date.

The goal of the Workshop is to identify optimal approaches and associated costs for surveying the South Atlantic deep-water species complex. Survey goals are expected to include providing abundance information and biological samples to support stock assessments of deep water species.

This meeting is accessible to people with disabilities. Requests for auxiliary aids should be directed to the SAFMC office (see ADDRESSES) at least 5 business days prior to the meeting.

The subject permit is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361 et seq.), the regulations governing the taking and importing of marine mammals (50 CFR part 216), the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq.), the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR 222-226).

The Minnesota Zoological Gardens (MZG) proposes to maintain up to eight non-releasable Hawaiian monk seals for research and enhancement purposes. This would include five female monk seals (currently being held at Sea World San Antonio) and any other captive or future non-releasable female monk seals taken under separate permit. The five seals currently at Sea World were collected from the wild for rehabilitation under an enhancement permit and deemed non-releasable due to an eye disease of unknown etiology; maintaining these seals in captivity would prevent the potential transmission of disease to the wild population. Proposed research on the captive seals includes the following: (1) Annually, blood samples and nasal swabs taken during routine health assessments will be analyzed for presence of West Nile virus, canine distemper virus, and phocine distemper virus in seals previously vaccinated; (2) various sedatives will be tested on the seals during routine health assessments to inform use in the wild population; and (3) seals may be used in research projects authorized under separate permits (e.g., vaccination testing, remotely administrating sedatives, new capture techniques). MZG proposes to maintain the seals for the duration of their lives and will continue public awareness on the status of the species through education and public observation of the seals. The permit is requested for the maximum 5-year period.

In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.), an initial determination has been made that the activity proposed is categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement.

Concurrent with the publication of this notice in the Federal Register, NMFS is forwarding copies of the application to the Marine Mammal Commission and its Committee of Scientific Advisors.

The primary purpose of the GMT working meeting is to prepare for the April 2015 Council meeting. Specific agenda topics include NOAA's proposed revisions to National Standards 1, 3, and 7; a review of the latest West Coast Groundfish Observer Program data; inseason adjustments to groundfish fisheries including carryover for the shorebased individual fishing quota program; further consideration for flexible management of annual catch limit set-asides; and comments on a Council Operating Procedure for methodology reviews. The GMT may also address other assignments relating to groundfish management. No management actions will be decided by the GMT. Public comment will be accommodated if time allows, at the discretion of the GMT Chair. The GMT's task will be to develop recommendations for consideration by the Pacific Council at its April 10-16, 2015 meeting in Rohnert Park, CA.

Although non-emergency issues not contained in the meeting agenda may be discussed, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this document and any issues arising after publication of this document 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 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 Mr. Kris Kleinschmidt at (503) 820-2425 at least 5 days prior to the meeting date.

Background

On November 16, 1994, the Department published the AD order on fresh garlic from the PRC in the Federal Register.2 On September 4, 2014, Qingshui requested that the Department conduct a CCR pursuant to section 751(b)(1) of the Act and 19 CFR 351.216(b) to determine that it is the successor-in-interest to Cangshan Qingshui for purposes of the Order. 3 We received comments from no other parties.

Based on this information, the Department initiated this CCR on October 16, 2014, explaining that while there was sufficient evidence to initiate a changed circumstances review, the Department needed to request additional information for this review as provided by 19 CFR 351.221(b)(2).4 On October 29, 2014, the Department issued its initial CCR questionnaire to Qingshui, and Qingshui timely responded to the Department's questionnaire.5 The Department did not receive comments from other interested parties concerning Qingshui's questionnaire response.

The merchandise covered by this order is all grades of garlic, whether whole or separated into constituent cloves. The subject merchandise is currently classifiable under the Harmonized Tariff Schedule of the United States (HTSUS) subheadings: 0703.20.0000, 0703.20.0010, 0703.20.0020, 0703.20.0090, 0710.80.7060, 0710.80.9750, 0711.90.6000, 0711.90.6500, 2005.90.9500, 2005.90.9700, 0703.20.0005, 2005.99.9700 and 0703.20.0015. Although the HTSUS subheadings are provided for convenience and customs purposes, the written product description is dispositive.

A complete description of the scope of the order is contained in the Preliminary Decision Memorandum.6 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 (ACCESS). ACCESS is available to registered users at http://access.trade.gov, and ACCESS 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 at http://enforcement.trade.gov/frn/index.html. The signed Preliminary Decision Memorandum and the electronic versions of the Preliminary Decision Memorandum are identical in content.

In accordance with section 751(b)(1) of the Act, we are conducting this changed circumstances review based upon the information contained in Qingshui's submissions.7 In making a successor-in-interest determination, the Department typically examines several factors including, but not limited to, changes in: (1) Management; (2) production facilities; (3) supplier relationships; and (4) customer base.8 While no single factor or combination of factors will necessarily be dispositive, the Department generally will consider the new company to be the successor to the predecessor if the resulting operations of the successor are not materially dissimilar to that of its predecessor.9 Thus, if the record demonstrates that, with respect to the production and sale of the subject merchandise, the new company operates as the same business entity as the predecessor company, the Department may assign the new company the cash deposit rate of its predecessor.10 For a full description of the methodology underlying our conclusions, see the Preliminary Decision Memorandum.

Based on the evidence reviewed, we preliminarily determine that Qingshui is the successor-in-interest to Cangshan Qingshui. Specifically, we find that any changes that may have occurred after “Cangshan Qingshui Vegetable Foods Co., Ltd” became “Lanling Qingshui Vegetable Foods Co., Ltd.” did not constitute material changes to management, production facilities, supplier relationships, customer relationships, or ownership/legal structure with respect to the production and sale of the subject merchandise. Thus, we preliminarily determine that Qingshui operates as the same business entity as Cangshan Qingshui with respect to the subject merchandise. A list of topics discussed in the Preliminary Decision Memorandum appears in the Appendix to this notice.

If the Department upholds these preliminary results in the final results, Qingshui will be assigned the cash deposit rate currently assigned to Cangshan Qingshui with respect to the subject merchandise (i.e., the $3.06 per kilogram cash deposit rate currently assigned to Cangshan Qingshui).11 If these preliminary results are adopted in the final results of this changed circumstances review, we will instruct U.S. Customs and Border Protection to suspend liquidation of entries of fresh garlic made and exported by Qingshui, effective on the publication date of the final results, at the cash deposit rate assigned to Cangshan Qingshui.

Interested parties may submit written comments by no later than 30 days after the date of publication of these preliminary results of review in the Federal Register. 12 Rebuttals, limited to issues raised in the written comments, may be filed by no later than five days after the written comments are filed.13 Parties that submit written comments or rebuttals 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.14 All briefs are to be filed electronically using ACCESS.15 An electronically filed document must be received successfully in its entirety by ACCESS by 5:00 p.m. Eastern Time on the day on which it is due.16

Any interested party may request a hearing to the Assistant Secretary of Enforcement and Compliance using ACCESS within 30 days of publication of this notice in the Federal Register. 17 Hearing requests should contain the following information: (1) The party's name, address, and telephone number; (2) the number of participants; and (3) a list of the issues to be discussed.18 Oral presentations will be limited to issues raised in the briefs. If a request for a hearing is made, parties will be notified of the time and date for the hearing to be held at the U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230.19

In accordance with 19 CFR 351.216(e), the Department intends to issue the final results of this changed circumstances review, not later than 270 days after the date on which the review is initiated.

The Department issues and publishes these results in accordance with sections 751(b)(1) and 777(i)(1) of the Act and 19 CFR 351.216 and 351.221.

NOAA awarded the National Fisheries Institute (NFI) a grant through the 2014 Atlantic sea scallop research set-aside program in support of a project titled, “Determining Incidental Discard Mortality of Atlantic Sea Scallops, Placopecten magellanicus, in the Scallop Dredge Fishery in the Mid-Atlantic Bight.” NFI submitted a complete Exempted Fishing Permit (EFP) application on May 13, 2014, but delayed work on the project until spring of 2015. NFI is requesting exemptions that would allow one commercial fishing vessel to fish outside of the limited access Atlantic sea scallop days-at-sea (DAS) regulations found at 50 CFR 648.53(b); mesh size restrictions at § 648.51(a)(2); obstruction in dredge gear restrictions at § 648.51(b)(4)(iii); and the crew size regulations at § 648.51(c). In addition, the EFP would temporarily exempt the participating vessel from possession limits and minimum size requirements specified in 50 CFR part 648, subsections B and D through O, for sampling purposes only. Any fishing activity conducted outside the scope of the exempted fishing activity would be prohibited.

The project would conduct dredging activities to assess the incidental mortality of scallops passing through the 4-inch (10.16-cm) rings of a 12-foot (4.57-meter) Turtle Deflector Dredge on sandy and hard (gravel) substrates. Dredging would be conducted over approximately 5 DAS during the proposed period of May 2015 through June 2015. All dredging would occur in open access scallop fishing areas off the coast of New Jersey. A total of 20 scallop tows would be conducted (10 tows per substrate). Each tow would be made at depths of 18 to 25 fathoms for a duration of 40 minutes. The scallop vessel would fish two dredges simultaneously. One dredge would use an experimental net bag cover and the other would fish with the industry standard 12-foot (4.57-meter) turtle excluder dredge. The experimental cover is constructed of 17/8-inch (4.76-cm) mesh and sewn into the top of the dredge apron. The bag can be dumped independently of the 4-inch (10.16-cm) ring bag to collect the scallops and other organisms that pass through the 4-inch (10.16-cm) rings. The dredge configurations would be switched to the opposite side after five tows for each substrate.

All scallops that filter through the 4-inch (10.16-cm) rings and into the mesh bag would be measured for shell height and assessed for damage to the shell in one of three categories: Not injured; sub-lethal (repairable); or lethal (non-repairable). After shell condition is assessed, shells would be spray painted with tow number in the corresponding spray paint color and placed in a whelk pot, which would be attached to the sea floor near the fishing grounds. Two additional DAS would be utilized, one each at 1 week and 2 weeks after initial survey, to assess mortality based on initial damage. The whelk pots would be removed from the ocean bottom after week-two sampling is complete. The weight of scallop catch retained in the 4-inch (10.16-cm) ring bags of both dredges would be estimated by the captain. Researchers would take shell measurements of a subsample of 50 scallops per tow per dredge to determine size selectivity within each dredge. All other bycatch in the experimental net bag would be sorted, the captain would estimate the weights, and researchers would measure a minimum of 25 lengths per individual species. No catch would be landed for sale.

If approved, the applicant may request minor modifications and extensions to the EFP throughout the year. EFP modifications and extensions may be granted without further notice if they are deemed essential to facilitate completion of the proposed research and have minimal impacts that do not change the scope or impact of the initially approved EFP request. Any fishing activity conducted outside the scope of the exempted fishing activity would be prohibited.

The Habitat AP will work on updating existing and developing new Council Essential Fish Habitat (EFH) Policy Statements and providing guidance on continued development of Fishery Ecosystem Plan II. The AP will receive presentations from Bureau of Ocean Energy Management (BOEM) Office of Renewable Energy Programs and BOEM Outer Continental Shelf/Geological and Geophysical Programs on mapping, characterization, impact analyses and planning efforts in the South Atlantic Region.

The AP will subsequently discuss redrafting the EFH Policy Statement on Energy Exploration, Development and Transportation. The AP will provide recommendations to the Council for consideration.

The meeting is physically accessible to people with disabilities. Requests for auxiliary aids should be directed to the Council office (see ADDRESSES) 3 days prior to the meeting.

Title of Collection: Generic Information Collection Plan for Surveys Using the Consumer Credit Panel.

OMB Control Number: 3170-XXXX.

Type of Review: Request for a new OMB Control Number.

Affected Public: Individuals and Households.

Estimated Number of Respondents: 8,500.

Estimated Total Annual Burden Hours: 4,250.

Abstract: Under the Dodd-Frank Wall Street Reform and Consumer Protection Act, the Consumer Financial Protection Bureau is charged with researching, analyzing, and reporting on topics relating to the Bureau's mission, including consumer behavior, consumer awareness, and developments in markets for consumer financial products and services. In order to improve its understanding of how consumers engage with financial markets, the CFPB uses the Consumer Credit Panel, a proprietary sample dataset from one of the national credit reporting agencies, as a frame to survey people about their experiences in consumer credit markets. The Bureau seeks to obtain approval for a generic information collection plan for these types of surveys. Survey responses will be used for general, formative, and informational research on consumer financial markets and consumers' use of financial products and will not directly provide the basis for specific policymaking at the Bureau.

Request for Comments: Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the Bureau, including whether the information will have practical utility; (b) The accuracy of the Bureau's estimate of the burden of the collection of information, including the validity of the methods and the assumptions used; (c) Ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget (OMB) approval. All comments will become a matter of public record.

Title of Collection: Generic Information Collection Plan to Conduct Cognitive Research and Pilot Testing.

OMB Control Number: 3170-XXXX.

Type of Review: Request for New OMB Control Number.

Affected Public: Individuals and Households.

Estimated Number of Respondents: 7,890.

Estimated Total Annual Burden Hours: 8,235.

Abstract: Under the Dodd-Frank Wall Street Reform and Consumer Protection Act, the Consumer Financial Protection Bureau is charged with researching, analyzing, and reporting on topics relating to the Bureau's mission, including developments in markets for consumer financial products and services, consumer awareness, and consumer behavior. In order to improve its understanding of how consumers engage with financial markets, the CFPB seeks to obtain approval for a generic information collection plan to conduct research to improve the quality of data collection by examining the effectiveness of data-collection procedures and processes, including potential psychological and cognitive issues.

Request for Comments: Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the Bureau, including whether the information will have practical utility; (b) The accuracy of the Bureau's estimate of the burden of the collection of information, including the validity of the methods and the assumptions used; (c) Ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget (OMB) approval. All comments will become a matter of public record.

Meeting Announcement: The Designated Federal Officer (DFO) for the Board of Visitors of the U.S. Air Force Academy has cancelled the previously scheduled meeting for March 16, 2015. Due to the timing of this decision, which was beyond the control of the Department of Defense or the DFO, the DFO was unable to ensure compliance with the requirements of 41 CFR 102-3.150(a). Accordingly, the Advisory Committee Management Officer for the Department of Defense, pursuant to 41 CFR 102-3.150(b), waives the 15-calendar day notification requirement.

The U.S. Marine Corps' notices for systems of records subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended, have been published in the Federal Register and are available from the address in FOR FURTHER INFORMATION CONTACT or from the Defense Privacy and Civil Liberties Office Web site at http://dpcld.defense.gov/.

The proposed system report, as required by 5 U.S.C. 552a(r) of the Privacy Act of 1974, as amended, was submitted on December 16, 2014, to the House Committee on Oversight and Government Reform, the Senate Committee on Governmental Affairs, and the Office of Management and Budget (OMB) pursuant to paragraph 4c of Appendix I to OMB Circular No. A-130, “Federal Agency Responsibilities for Maintaining Records About Individuals,” dated February 8, 1996 (February 20, 1996, 61 FR 6427).

The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

Title of Collection: Pell Grant Reporting under the Common Origination and Disbursement (COD) System.

OMB Control Number: 1845-0039.

Type of Review: An extension of an existing information collection.

Respondents/Affected Public: Private Sector, State, Local and Tribal Governments.

Total Estimated Number of Annual Responses: 8,488,842.

Total Estimated Number of Annual Burden Hours: 594,219.

Abstract: The Federal Pell Grant program is a student financial assistance program authorized under the Higher Education Act of 1965, as amended. The program provides grant assistance to an eligible student attending an institution of higher education. The institution determines the student's award and disburses program funds on behalf of the Department of Education (ED).

Institutions are required to report student Pell Grant payment information to ED electronically. Electronic reporting is conducted through the Common Origination and Disbursement (COD) system. The COD system is used by institutions to request, report and reconcile grant funds received from the Pell Grant program.

Exports of electricity from the United States to a foreign country are regulated by the Department of Energy (DOE) pursuant to sections 301(b) and 402(f) of the Department of Energy Organization Act (42 U.S.C. 7151(b), 7172(f)) and require authorization under section 202(e) of the Federal Power Act (16 U.S.C. 824a(e)).

On June 9, 2010, DOE issued Order No. EA-185-C to the applicant, which authorized MSCG to transmit electric energy from the United States to Canada as a power marketer for a five-year term using existing international transmission facilities. That authority expires on August 21, 2015. On March 2, 2015, the Applicant filed an application with DOE for renewal of the export authority contained in Order No. EA-185-C for an additional five-year term.

In its application, the Applicant states that it does not own or operate any electric generation or transmission facilities, and it does not have a franchised service area. The electric energy that the Applicant proposes to export to Canada would be surplus energy purchased from third parties such as electric utilities and Federal power marketing agencies pursuant to voluntary agreements. The existing international transmission facilities to be utilized by the Applicant have previously been authorized by Presidential permits issued pursuant to Executive Order 10485, as amended, and are appropriate for open access transmission by third parties.

Procedural Matters: Any person desiring to be heard in this proceeding should file a comment or protest to the application at the address provided above. Protests should be filed in accordance with Rule 211 of the Federal Energy Regulatory Commission's (FERC) Rules of Practice and Procedures (18 CFR 385.211). Any person desiring to become a party to these proceedings should file a motion to intervene at the above address in accordance with FERC Rule 214 (18 CFR 385.214). Five copies of such comments, protests, or motions to intervene should be sent to the address provided above on or before the date listed above.

Comments and other filings concerning the MSCG's application to export electric energy to Canada should be clearly marked with OE Docket No. EA-185-D. An additional copy is to be provided directly to both Edward J. Zabrocki, Morgan Stanley & Co. LLC, 2000 Westchester Ave., 1st Floor, Purchase, NY 10577 and Daniel E. Frank, Sutherland Asbill & Brennan LLP, 700 Sixth Street NW., Suite 700, Washington, DC 20001.

A final decision will be made on this application after the environmental impacts have been evaluated pursuant to DOE's National Environmental Policy Act Implementing Procedures (10 CFR part 1021) and after a determination is made by DOE that the proposed action will not have an adverse impact on the sufficiency of supply or reliability of the U.S. electric power supply system.

Copies of this application will be made available, upon request, for public inspection and copying at the address provided above, by accessing the program Web site at http://energy.gov/node/11845, or by emailing Angela Troy at [email protected].

Title II of FUA, as amended (42 U.S.C. 8301 et seq.), provides that no new base load electric powerplant may be constructed or operated without the capability to use coal or another alternate fuel as a primary energy source. Pursuant to FUA in order to meet the requirement of coal capability, the owner or operator of such a facility proposing to use natural gas or petroleum as its primary energy source shall certify to the Secretary of Energy (Secretary) prior to construction, or prior to operation as a base load electric powerplant, that such powerplant has the capability to use coal or another alternate fuel. Such certification establishes compliance with FUA section 201(a) as of the date it is filed with the Secretary. 42 U.S.C. 8311.

The following owner of a proposed new base load electric powerplant has filed a self-certification of coal-capability with DOE pursuant to FUA section 201(d) and in accordance with DOE regulations in 10 CFR 501.60, 61:

Owner: NTE Ohio, LLC.

Capacity: 525 megawatts (MW).

Plant Location: Cincinnati Dayton Road, Middletown, Ohio.

In-Service Date: As early as January 2018.

Title II of FUA, as amended (42 U.S.C. 8301 et seq.), provides that no new base load electric powerplant may be constructed or operated without the capability to use coal or another alternate fuel as a primary energy source. Pursuant to FUA in order to meet the requirement of coal capability, the owner or operator of such a facility proposing to use natural gas or petroleum as its primary energy source shall certify to the Secretary of Energy (Secretary) prior to construction, or prior to operation as a base load electric powerplant, that such powerplant has the capability to use coal or another alternate fuel. Such certification establishes compliance with FUA section 201(a) as of the date it is filed with the Secretary. 42 U. S. C. 8311.

The following owner of a proposed new base load electric powerplant has filed a self-certification of coal-capability with DOE pursuant to FUA section 201(d) and in accordance with DOE regulations in 10 CFR 501.60, 61:

Owner: NTE Carolinas, LLC.

Capacity: 475 megawatts (MW).

Plant Location: Gage Road, Kings Mountain, NC 28086.

In-Service Date: As early as January 2018.

Requests to make oral comments, or provide written comments to the committees, should be sent to Oscar Carrillo, Designated Federal Officer, at the contact information above. If you plan to attend, please register with Ms. Stephanie McCoy, by April 9th by calling 202-564-7297 or via email at [email protected]. Please provide your name, organization, address and telephone number.

Meeting Access: For information on access or services for individuals with disabilities, or to request accommodation of a disability, please contact Oscar Carrillo, at least 10 days prior to the meeting to give EPA as much time as possible to process your request.

Members of the public wishing to gain access to the teleconference, make brief oral comments, or provide a written statement to the NEEAC must contact Javier Araujo, Designated Federal Officer, at [email protected] or 202-564-2642 by 10 business days prior to each regularly scheduled meeting. Meeting Access: For information on access or services for individuals with disabilities or to request accommodations, please contact Javier Araujo at [email protected] or 202-564-2642, preferably at least 10 days prior to the meeting, to give EPA as much time as possible to process your request.

OMB Control Number: 3060-0636.

Title: Sections 2.906, 2.909, 2.1071, 2.1075, 2.1077 and 15.37, Equipment Authorizations—Declaration of Conformity.

Form No.: Not applicable.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit entities.

Number of Respondents: 6,000 respondents; 12,000 responses.

Estimated Time per Response: 9.5 hours (average).

Frequency of Response: One-time reporting requirement, recordkeeping requirement and third party disclosure requirements.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 154(i), 301, 302, 303(e), 303(r), 304 and 307.

Total Annual Burden: 114,000 hours.

Total Annual Cost: $24,000,000.

Privacy Act Impact Assessment: No impact.

Nature and Extent of Confidentiality: No assurances of confidentiality are provided to respondents.

Needs and Uses: The Commission will submit this information collection to Office of Management and Budget (OMB) after this 60 day comment period in order to obtain the full three year clearance from them. The Commission is requesting an extension, there is no change in the reporting, recordkeeping and/or third party disclosure requirements. The Commission is reporting an adjustment to reflect an increase to the total number of respondents/responses, the total annual hourly burden, and the total annual cost to respondents from the previous estimates, in order to reflect an increase in the number of devices authorized under the DOC program.

In 1996, the Declaration of Conformity (DoC) procedure was established in a Report and Order, FCC 96-208, In the Matter of Amendment of Parts 2 and 15 of the Commission's Rules to Deregulate the Equipment Authorization Requirements for Digital Devices.

(a) The Declaration of Conformity equipment authorization procedure, 47 CFR 2.1071, requires that a manufacturers or equipment supplier test a product to ensure compliance with technical standards that limit radio frequency emissions.

(b) Additionally, the manufacturer or supplier must also include a DoC (with the standards) in the literature furnished with the equipment, and the equipment manufacturer or supplier must also make this statement of conformity and supporting technical data available to the FCC, at the Commission's request.

(c) The DoC procedure represents a simplified filing and reporting procedure for authorizing equipment for marketing.

(d) Finally, testing and documentation of compliance are needed to control potential interference to radio communications. The data gathering are necessary for investigating complaints of harmful interference or for verifying the manufacturer's compliance with the Commission's rules.

OMB Control Number: 3060-0790.

Title: Section 68.110 (c), Availability of Inside Wiring Information.

Form Number: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit.

Number of Respondents: 200 respondents; 1,200 responses.

Estimated Time per Response: 1 hour.

Frequency of Response: Recordkeeping requirement and third party disclosure requirement.

Obligation to Respond: Mandatory. Statutory authority for this collection of information is contained in 47 U.S.C. 151, 154, 201-205, 218, 220 and 405 of the Communications Act of 1934, as amended.

Total Annual Burden: 1,200 hours.

Annual Cost Burden: $5,000.

Privacy Act Impact Assessment: No impact.

Nature and Extent of Confidentiality: The Commission is not requesting that respondents submit any confidential trade secrets or proprietary information to the FCC.

Needs and Uses: Section 68.110(c) requires that any available technical information concerning carrier-installed wiring on the customer's side of the demarcation point, including copies of existing schematic diagrams and service records, shall be provided by the telephone company upon request of the building owner or agent thereof. The provider of wireline telecommunications services may charge the building owner a reasonable fee for this service, which shall not exceed the cost involved in locating and copying the documents. In the alternative, the provider may make these documents available for review and copying by the building owner or his agent. In this case, the wireline telecommunications carrier may charge a reasonable fee, which shall not exceed the cost involved in making the documents available, and may also require the building owner or his agent to pay a deposit to guarantee the documents' return. The information is needed so that building owners may choose to contract with an installer of their choice on inside wiring maintenance and installation services to modify existing wiring or assist with the installation of additional inside wiring.

Background

The Patient Safety Act authorizes the listing of PSOs, which are entities or component organizations whose mission and primary activity are to conduct activities to improve patient safety and the quality of health care delivery.

HHS issued the Patient Safety Rule to implement the Patient Safety Act. AHRQ administers the provisions of the Patient Safety Act and Patient Safety Rule relating to the listing and operation of PSOs. The Patient Safety Rule authorizes AHRQ to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be “delisted” if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. Section 3.108(d) of the Patient Safety Rule requires AHRQ to provide public notice when it removes an organization from the list of federally approved PSOs.

AHRQ has accepted a notification from PSO Services Group, PSO number P0028, to voluntarily relinquish its status as a PSO. Accordingly, PSO Services Group was delisted effective at 12:00 Midnight ET (2400) on January 5, 2015.

PSO Services Group has patient safety work product (PSWP) in its possession. The PSO will meet the requirements of section 3.108(c)(2)(i) of the Patient Safety Rule regarding notification to providers that have reported to the PSO. In addition, according to sections 3.108(c)(2)(ii) and 3.108(b)(3) of the Patient Safety Rule regarding disposition of PSWP, the PSO has 90 days from the effective date of delisting and revocation to complete the disposition of PSWP that is currently in the PSO's possession.

More information on PSOs can be obtained through AHRQ's PSO Web site at http://www.pso.AHRQ.gov/index.html.

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

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

Requirements for drug establishment registration and drug listing are set forth in section 510 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360), section 351 of the Public Health Service Act (42 U.S.C. 262), and part 207 (21 CFR part 207). Fundamental to FDA's mission to protect the public health is the collection of this information, which is used for important activities such as postmarket surveillance for serious adverse drug reactions, inspection of drug manufacturing and processing facilities, and monitoring of drug products imported into the United States. Comprehensive, accurate, and up to date information is critical to conducting these activities with efficiency and effectiveness.

Under section 510 of the FD&C Act, FDA is authorized to establish a system for registration of producers of drugs and for listing of drugs in commercial distribution. To implement section 510 of the FD&C Act, FDA issued part 207. Under current § 207.20, manufacturers, repackers, and relabelers that engage in the manufacture, preparation, propagation, compounding, or processing of human or veterinary drugs and biological products, including bulk drug substances and bulk drug substances for prescription compounding, and drug premixes as well as finished dosage forms, whether prescription or over-the-counter, are required to register their establishment. In addition, manufacturers, repackers, and relabelers are required to submit a listing of every drug or biological product in commercial distribution. Owners or operators of establishments that distribute under their own label or trade name a drug product manufactured by a registered establishment are not required either to register or list. However, distributors may elect to submit drug listing information in lieu of the registered establishment that manufactures the drug product. Foreign drug establishments must also comply with the establishment registration and product listing requirements if they import or offer for import their products into the United States.

Under current § 207.21, establishments, both domestic and foreign, must register with FDA within 5 days after beginning the manufacture of drugs or biologicals, or within 5 days after the submission of a drug application or biological license application. In addition, establishments must register annually. Changes in individual ownership, corporate or partnership structure, location, or drug handling activity must be submitted as amendments to registration under current § 207.26 within 5 days of such changes. Under § 207.20(b), private label distributors may request their own labeler code and elect to submit drug listing information to FDA. In such instances, at the time of submitting or updating drug listing information, private label distributors must certify to the registered establishment that manufactured, prepared, propagated, compounded, or processed (which includes, among other things, repackaging and relabeling) the listed drug that the drug listing submission was made. Establishments must, within 5 days of beginning the manufacture of drugs or biologicals, submit to FDA a listing for every drug or biological product in commercial distribution at that time. Private label distributors may elect to submit to FDA a listing of every drug product they place in commercial distribution. Registered establishments must submit to FDA drug product listing for those private label distributors who do not elect to submit listing information.

Under § 207.25, product listing information submitted to FDA by domestic and foreign manufacturers must, depending on the type of product being listed, include any new drug application number or biological establishment license number, copies of current labeling and a sampling of advertisements, a quantitative listing of the active ingredient for each drug or biological product not subject to an approved application or license, the NDC number, and any drug imprinting information.

In addition to the product listing information required, FDA may also require, under § 207.31, a copy of all advertisements and a quantitative listing of all ingredients for each listed drug or biological product not subject to an approved application or license; the basis for a determination, by the establishment, that a listed drug or biological product is not subject to marketing or licensing approval requirements; and a list of certain drugs or biological products containing a particular ingredient. FDA may also request, but not require, the submission of a qualitative listing of the inactive ingredients for all listed drugs or biological products, and a quantitative listing of the active ingredients for all listed drugs or biological products subject to an approved application or license.

Under § 207.30, establishments must update their product listing information every June and December or, at the discretion of the establishment, when any change occurs. These updates must include the following information: (1) A listing of all drug or biological products introduced for commercial distribution that have not been included in any previously submitted list; (2) all drug or biological products formerly listed for which commercial distribution has been discontinued; (3) all drug or biological products for which a notice of discontinuance was submitted and for which commercial distribution has been resumed; and (4) any material change in any information previously submitted. No update is required if no changes have occurred since the previously submitted list.

Historically, drug establishment registration and drug listing information have been submitted in paper form using Form FDA 2656 (Registration of Drug Establishment/Labeler Code Assignment), Form FDA 2657 (Drug Product Listing), and Form FDA 2658 (Registered Establishments' Report of Private Label Distributors) (collectively referred to as FDA Forms). Changes in the FD&C Act resulting from enactment of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) (FDAAA) require that drug establishment registration and drug listing information be submitted electronically unless a waiver is granted. Before the enactment of FDAAA, section 510(p) of the FD&C Act expressly provided for electronic submission of drug establishment registration information upon a finding that electronic receipt was feasible, and section 510(j) of the FD&C Act provided that drug listing information be submitted in the form and manner prescribed by FDA. Section 224 of FDAAA, which amends section 510(p) of the FD&C Act, now expressly, requires electronic drug listing in addition to drug establishment registration. In certain cases, if it is unreasonable to expect a person to submit registration and listing information electronically, FDA may grant a waiver from the electronic format requirement.

In the Federal Register of June 1, 2009 (74 FR 26248), FDA announced the availability of a guidance for industry entitled “Providing Regulatory Submissions in Electronic Format—Drug Establishment Registration and Drug Listing” (the 2009 guidance). The document provides guidance to industry on the statutory requirement to submit electronically drug establishment registration and drug listing information. The guidance describes the types of information to include for purposes of drug establishment registration and drug listing and how to prepare and submit the information in an electronic format (Structured Product Labeling (SPL) files) that FDA can process, review, and archive. In addition to the information that previously was collected on the FDA Forms, the guidance addresses electronic submission of other required information as follows:

• For registered foreign drug establishments, the name, address, and telephone number of its U.S. agent (§ 207.40(c));

• the name of each importer that is known to the establishment (the U.S. company or individual in the United States that is an owner, consignee, or recipient of the foreign establishment's drug that is imported into the United States. An importer does not include the consumer or patient who ultimately purchases, receives, or is administered the drug, unless the foreign establishment ships the drug directly to the consumer or the patient) (section 510(i)(1)(A) of the FD&C Act); and

• the name of each person who imports or offers for import (the name of each agent, broker, or other entity, other than a carrier, that the foreign drug establishment uses to facilitate the import of their drug into the United States) (section 510(i)(1)(A) of the FD&C Act).

FDA also recommends the voluntary submission of the following additional information, when applicable:

• To facilitate correspondence between foreign establishments and FDA, the email address for the U.S. agent, and the telephone number(s) and email address for the importer and person who imports or offers for import their drug;

• a site-specific Data Universal Numbering System number for each entity (e.g., the registrant, establishments, U.S. agent, importer);

• the NDC product code for the source drug that is repacked or relabeled;

• distinctive characteristics of certain listed drugs, i.e., the flavor, the color, and image of the actual solid dosage form; and

• registrants may indicate that they view as confidential the registrant's business relationship with an establishment, or an inactive ingredient.

In addition to this collection of information, there is an additional burden for the following activities:

• preparing a standard operating procedure (SOP) for the electronic submission of drug establishment registration and drug listing information;

• creating the SPL file, including accessing and reviewing the technical specifications and instructional documents provided by FDA (accessible at http://www.fda.gov/oc/datacouncil/spl.html);

• reviewing and selecting appropriate terms and codes used to create the SPL file (accessible at http://www.fda.gov/oc/datacouncil/spl.html);

• obtaining the digital certificate used with FDA's electronic submission gateway and uploading the SPL file for submission (accessible at http://www.fda.gov/esg/default.htm); and

• requests for waivers from the electronic submission process as described in the draft guidance.

When FDA published the 2009 guidance on submitting establishment registration and drug listing information in electronic format, the Agency also amended its burden estimates for OMB control number 0910-0045 to include the additional burden for the collection of information that had not been submitted using the FDA forms, and to create and upload the SPL file. The amended burden estimates included the one-time preparation of an SOP for creating and uploading the SPL file. Although most firms will already have prepared an SOP for the electronic submission of drug establishment registration and drug listing information, each year additional firms will need to create an SOP. As provided in Table 2 of this document, FDA estimates that approximately 1,000 firms will have to expend a one-time burden to prepare, review, and approve an SOP, and the Agency estimates that it will take 40 hours per recordkeeper to create 1,000 new SOPs for a total of 40,000 hours.

In Tables 1 and 2, the information collection requirements of the drug establishment registration and drug listing requirements have been grouped according to the information collection areas of the requirements.

FDA is announcing the availability of a document entitled “Electronic Submission of Lot Distribution Reports; Guidance for Industry.” The guidance provides information and recommendations pertaining to the electronic submission of lot distribution reports. The guidance provides information on how to electronically submit lot distribution reports for biological products under approved BLAs for which CBER or CDER has regulatory responsibility. The guidance does not apply to any other biological product.

FDA published in the Federal Register of June 10, 2014 (79 FR 33072), a final rule requiring electronic submission of certain postmarketing submissions. Among other things, under this rule applicants are required to submit biological lot distribution reports to FDA in an electronic format that the Agency can process, review, and archive. The guidance is intended to help applicants subject to lot distribution reporting comply with the final rule. Along with other information, the guidance provides updated information about the following: (1) Structured Product Labeling standard and vocabulary for electronic submission of lot distribution reporting; (2) additional resources such as implementation guide, validation procedures and links with further information; and (3) procedures for requesting temporary waivers from the electronic submission requirement.

In the Federal Register of August 29, 2014 (79 FR 51576), FDA announced the availability of the draft guidance entitled ” Guidance for Industry: Electronic Submission of Lot Distribution Reports” dated August 2014. FDA published a correction notice to correct the docket number in the Federal Register of September 16, 2014 (79 FR 55497). FDA received a few comments on the draft guidance and those comments were considered as the guidance was finalized. FDA is finalizing the draft guidance with only editorial changes. The guidance announced in this notice finalizes the draft guidance dated August 2014.

The guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents FDA's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR 600.81 and 600.90 have been approved under 0910-0308.

Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

Persons with access to the Internet may obtain the guidance at either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or http://www.regulations.gov.

The technology describes a method of identifying cancer patients that may benefit from mTOR analog-based chemotherapy or agents directed against the AKT pathway.

The prospective exclusive evaluation license is being considered under the small business initiative launched on 1 October 2011, and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive evaluation option license, and a subsequent exclusive commercialization license, may be granted unless the NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404 within fifteen (15) days from the date of this published notice.

Complete applications for a license in the field of use filed in response to this notice will be treated as objections to the grant of the contemplated exclusive evaluation option license. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.

The Patient Safety Act authorizes the listing of PSOs, which are entities or component organizations whose mission and primary activity are to conduct activities to improve patient safety and the quality of health care delivery.

HHS issued the Patient Safety Rule to implement the Patient Safety Act. AHRQ administers the provisions of the Patient Safety Act and Patient Safety Rule relating to the listing and operation of PSOs. The Patient Safety Rule authorizes AHRQ to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be “delisted” if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when the PSO's listing expires. Section 3.108(d) of the Patient Safety Rule requires AHRQ to provide public notice when it removes an organization from the list of federally approved PSOs. Premerus PSO, LLC, PSO number P0120, a component entity of Premerus, Inc., chose to let its listing expire by not seeking continued listing. Accordingly, Premerus PSO, LLC was delisted effective at 12:00 Midnight ET (2400) on January 10, 2015.

More information on PSOs can be obtained through AHRQ's PSO Web site at http://www.pso.AHRQ.gov/index.html.

5T4 is an antigen expressed in a number of carcinomas. Its expression is limited in normal tissue, but is prevalent in malignant tumors throughout their development. This confined expression makes it an attractive target for cancer immunotherapy. 5T4 is often found in colorectal, ovarian, and gastric tumors and thus has been used as a prognostic aid for these cancers. In addition, its role in antibody-directed immunotherapy for delivering response modifiers to tumors has been studied using murine monoclonal antibodies (mAbs) and the cancer vaccine TroVax (currently in clinical trials for multiple solid tumors) targets 5T4. The present invention describes the identification and characterization of two fully human mAbs (m1001 and m1002) that bind to 5T4. Since the mAbs are fully human, they could have less immunogenicity and better safety profiles than the existing mouse and humanized antibodies.

The prospective start-up exclusive commercial license is being considered under the small business initiative launched on October 1, 2011 and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 404. The prospective start-up exclusive commercial license may be granted unless within fifteen (15) days from the date of this published notice, the NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.

Any additional, properly filed, and complete applications for a license in the field of use filed in response to this notice will be treated as objections to the grant of the contemplated exclusive commercial license. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.

Proposed Project Medical Office Survey on Patient Safety Culture Comparative Database

Background on the Medical Office Survey on Patient Safety Culture (Medical Office SOPS). In 1999, the Institute of Medicine called for health care organizations to develop a “culture of safety” such that their workforce and processes focus on improving the reliability and safety of care for patients (IOM, 1999; To Err is Human: Building a Safer Health System). To respond to the need for tools to assess patient safety culture in health care, AHRQ developed and pilot tested the Medical Office SOPS with OMB approval (OMB NO. 0935-0131; Approved July 5, 2007).

The survey is designed to enable medical offices to assess provider and staff opinions about patient safety issues, medical error, and error reporting. The survey includes 38 items that measure 10 composites of patient safety culture. In addition to the composite items, 14 items measure how often medical offices have problems exchanging information with other settings and other patient safety and quality issues. AHRQ made the survey publicly available along with a Survey User's Guide and other toolkit materials in December 2008 on the AHRQ Web site (located at http://www.ahrq.gov/professionals/quality-patient-safety/patientsafetyculture/medical-office/index.html). Since its release, the survey has been voluntarily used by hundreds of medical offices in the U.S.

The Medical Office SOPS Comparative Database consists of data from the AHRQ Medical Office Survey on Patient Safety Culture. Medical offices in the U.S. are asked to voluntarily submit data from the survey to AHRQ, through its contractor Westat. The Medical Office SOPS Database (OMB NO. 0935-0196, last approved on June 12, 2012) was developed by AHRQ in 2011 in response to requests from medical offices interested in knowing how their patient safety culture survey results compare to those of other medical offices in their efforts to improve patient safety.

Rationale for the information collection. The Medical Office SOPS and the Comparative Database support AHRQ's goals of promoting improvements in the quality and safety of health care in medical office settings. The survey, toolkit materials, and comparative database results are all made publicly available on AHRQ's Web site. Technical assistance is provided by AHRQ through its contractor at no charge to medical offices, to facilitate the use of these materials for medical office patient safety and quality improvement.

The goal of this project is to renew the Medical Office SOPS Comparative Database. This Database will:

(1) Allow medical offices to compare their patient safety culture survey results with those of other medical offices,

(2) Provide data to medical offices to facilitate internal assessment and learning in the patient safety improvement process, and

(3) Provide supplemental information to help medical offices identify their strengths and areas with potential for improvement in patient safety culture.

This study is being conducted by AHRQ through its contractor Westat, pursuant to AHRQ's statutory authority to conduct and support research on health care and on systems for the delivery of such care, including activities with respect to: The quality, effectiveness, efficiency, appropriateness and value of health care services; quality measurement and improvement; and database development. 42 U.S.C. 299a(a)(1), (2), and (8).

To achieve the goal of this project the following activities and data collections will be implemented:

(1) Eligibility and Registration Form—The medical office point-of-contact (POC) completes a number of data submission steps and forms, beginning with the completion of an online eligibility and registration form. The purpose of this form is to determine the eligibility status and initiate the registration process for medical offices seeking to voluntarily submit their Medical Office SOPS data to the Medical Office SOPS Comparative Database.

(2) Data Use Agreement—The purpose of the data use agreement, completed by the medical office POC, is to state how data submitted by medical offices will be used and provides confidentiality assurances.

(3) Medical Office Site Information Form—The purpose of the site information form is to obtain basic information about the characteristics of the medical offices submitting their Medical Office SOPS data to the Medical Office SOPS Comparative Database (e.g. number of providers and staff, ownership, and type of specialty). The medical office POC completes the form.

(4) Data Files Submission—The number of submissions to the database is likely to vary each year because medical offices do not administer the survey and submit data every year. Data submission is typically handled by one POC who is either an office manager, nurse manager, or a survey vendor who contracts with a medical office to collect their data. POCs submit data on behalf of 10 medical offices, on average, because many medical offices are part of a health system that includes many medical office sites, or the POC is a vendor that is submitting data for multiple medical offices. After registering, if registrants are deemed eligible to submit data, an automated email is sent to authenticate the account and update the user password. Next the POC enters medical office information and uploads the survey questionnaire and submits a data use agreement. POCs then upload their data file(s), using the medical office data file specifications, to ensure that users submit standardized and consistent data in the way variables are named, coded, and formatted.

Survey data from the AHRQ Medical Office SOPS are used to produce three types of products: (1) A Medical Office SOPS Comparative Database Report that is produced periodically and made publicly available on the AHRQ Web site (see http://www.ahrq.gov/professionals/quality-patient-safety/patientsafetyculture/medical-office/2014/index.html); (2) Individual Medical Office Survey Feedback Reports that are confidential, customized reports produced for each medical office that submits data to the database (the number of reports produced is based on the number of medical offices submitting each year); and (3) Research data sets of individual-level and medical office-level de-identified data to enable researchers to conduct analyses.

Medical offices are asked to voluntarily submit their Medical Office SOPS survey data to the Comparative Database. The data are then cleaned and aggregated and used to produce a Comparative Database Report that displays averages, standard deviations, and percentile scores on the survey's 38 items that measure 10 composites of patient safety culture, and 14 items measuring how often medical offices have problems exchanging information with other settings and other patient safety and quality issues. The report also displays these results by medical office characteristics (size of office, specialty, geographic region, etc.) and respondent characteristics (staff position).

Data submitted by medical offices are used to give each medical office its own customized survey feedback report that presents the medical office's results compared to the latest comparative database results.

Medical offices use the Medical Office SOPS, Comparative Database Reports and Individual Medical Office Survey Feedback Reports for a number of purposes, to

• Raise staff awareness about patient safety.

• Diagnose and assess the current status of patient safety culture in their medical office.

• Identify strengths and areas for improvement in patient safety culture.

• Evaluate the cultural impact of patient safety initiatives and interventions.

• Compare patient safety culture survey results with other medical offices in their efforts to improve patient safety and health care quality.

Exhibit 1 shows the estimated annualized burden hours for the respondents' time to participate in the database. An estimated 150 POCs, each representing an average of 10 individual medical offices each, will complete the database submission steps and forms annually. Completing the registration form will take about 3 minutes. The Medical Office Information Form is completed by all POCs for each of their medical offices (150 × 10 = 1,500 forms in total) and is estimated to take 5 minutes to complete. Each POC will complete a data use agreement which takes 3 minutes to complete and submitting the data will take an hour on average. The total burden is estimated to be 291 hours.

Exhibit 2 shows the estimated annualized cost burden based on the respondents' time to submit their data. The cost burden is estimated to be $13,968 annually.

In accordance with the Paperwork Reduction Act, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ health care research and health care information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.

Under Title IX of the Public Health Service Act, AHRQ is charged with enhancing the quality, appropriateness, and effectiveness of health care services and access to such services 42 U.S.C. 299(b). AHRQ accomplishes these goals through scientific research and promotion of improvements in clinical practice, including clinical prevention of diseases and other health conditions. See 42 U.S.C. 299(b).

The USPSTF, an independent body of experts in prevention and evidence- based medicine, works to improve the health of all Americans by making evidence-based recommendations about the effectiveness of clinical preventive services and health promotion. The recommendations made by the USPSTF address clinical preventive services for adults and children, and include screening tests, counseling services, and preventive medications.

The USPSTF was first established in 1984 under the auspices of the U.S. Public Health Service. Currently, the USPSTF is convened by the Director of AHRQ, and AHRQ provides ongoing scientific, administrative, and dissemination support for the USPSTF's operation. USPSTF members serve four year terms. New members are selected each year to replace those members who are completing their appointments.

The USPSTF is charged with rigorously evaluating the effectiveness, appropriateness and cost-effectiveness of clinical preventive services and formulating or updating recommendations regarding the appropriate provision of preventive services. See 42 U.S.C. 299b-4(a)(1). Current USPSTF recommendations and associated evidence reviews are available on the Internet (www.uspreventiveservicestaskforce.org).

USPSTF members currently meet three times a year for two days in the Washington, DC area. A significant portion of the USPSTF's work occurs between meetings during conference calls and via email discussions. Member duties include prioritizing topics, designing research plans, reviewing and commenting on systematic evidence reviews of evidence, discussing and making recommendations on preventive services, reviewing stakeholder comments, drafting final recommendation documents, and participating in workgroups on specific topics and methods. Members can expect to receive frequent emails, can expect to participate in multiple conference calls each month, and can expect to have periodic interaction with stakeholders. AHRQ estimates that members devote approximately 200 hours a year outside of in-person meetings to their USPSTF duties. The members are all volunteers and do not receive any compensation beyond support for travel to in person meetings.

Tyrosine kinase-like orphan receptor 1 (ROR1) is a signature cell surface antigen for B-cell malignancies, most notably, B-cell chronic lymphocytic leukemia (B-CLL) and mantle cell lymphoma (MCL) cells, two incurable diseases. The investigators have developed a portfolio of chimeric anti-ROR1 monoclonal antibodies that selectively target ROR1 malignant B-cells but not normal B-cells. These antibodies may be linked to chemical drugs or biological toxins thus providing targeted cytotoxic delivery to malignant B-cells while sparing normal cells. Moreover, as these antibodies selectively target ROR1, they can also be used to diagnose B-cell malignancies.

The prospective start-up exclusive evaluation option license is being considered under the small business initiative launched on October 1, 2011 and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 404. The prospective start-up exclusive evaluation option license, and a subsequent start-up exclusive patent commercialization license, may be granted unless within fifteen (15) days from the date of this published notice, the NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.

Any additional, properly filed, and complete applications for a license in the field of use filed in response to this notice will be treated as objections to the grant of the contemplated start-up exclusive evaluation option license. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.