April 2, 2013 – Federal Register Recent Federal Regulation Documents

Each Federal agency is required by the Privacy Act of 1974 to publish a description of a system of records containing personal information it establishes and maintains. This notice provides notification that NASA has established an internal system of records pertaining to carpool, parking, and other aspects of employee transit and transit benefits.

The Food and Drug Administration (FDA) is announcing a public meeting entitled ``International Consortium of Cardiovascular Registries.'' The purpose of this meeting is to discuss the development of an international consortium of cardiovascular registries with a broad array of interested stakeholders. The initial pilot phase of this effort will be developing relationships and analysis strategies for transcatheter cardiac valve registries, with the understanding that these efforts would be expanded to additional cardiovascular devices in the future. Date and Time: The meeting will be held on April 22, 2013, from 8 a.m. to 5 p.m. Location: The public meeting will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to https://www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation / ucm241740.htm. Contact Persons: Benjamin Eloff, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4210, Silver Spring, MD 20993, 301-796-8528, Benjamin.eloff@fda.hhs.gov; or Danica Marinac-Dabic, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4110, Silver Spring, MD 20993, 301-796- 6689, Danica.marinac-dabic@fda.hhs.gov. Registration: Registration is free and will be on a first-come, first-served basis. Persons interested in attending this public meeting must register online by 5 p.m. on April 11, 2013. Early registration is recommended because facilities are limited and, therefore, FDA may limit the number of participants from each organization. If time and space permit, onsite registration on the day of the public meeting will be provided beginning at 7 a.m. To register for the public meeting, please visit FDA's Medical Devices News & EventsWorkshops & Conferences calendar at https:// www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/de fault.htm. Select this public meeting from the posted events list. Please provide complete contact information for each attendee, including name, title, affiliation, mailing address, email address, and telephone number. Those without Internet access should contact Susan Monahan to register (Susan.Monahan@fda.hhs.gov or 301-796-5661). Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list. If you need special accommodations due to a disability, please contact Susan Monahan (Susan.Monahan@fda.hhs.gov or 301-796-5661) no later than April 11, 2013. Streaming Webcast of the Public Meeting: This meeting will also be available via Webcast. Persons interested in viewing the Webcast must register online by 5 p.m. on April 11, 2013. Early registration is recommended because Webcast connections are limited. Organizations are requested to register all participants, but to view using one connection per location. Webcast participants will be sent technical system requirements after registration and connection access information after April 16, 2013. If you have never attended a Connect Pro event before, test your connection at https:// collaboration.fda.gov/common/help/en/support/meetingtest.htm. To get a quick overview of the Connect Pro program, visit https:// www.adobe.com/go/connectprooverview. (FDA has verified the Web site addresses in this document, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) Comments: FDA is holding this public meeting to obtain information on the topics identified in section II. In order to permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the public meeting topics. The deadline for submitting comments related to this public meeting is May 22, 2013. No commercial or promotional material will be permitted to be presented or distributed at the meeting. Regardless of attendance at the public meeting, interested persons may submit either electronic comments regarding this document to http:/ /www.regulations.gov or written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. Please 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 https://www.regulations.gov. Transcripts: Transcripts will not be provided.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``User Fees and Refunds for Premarket Approval Applications (PMAs) and Device Biologics License Applications (BLAs).'' The purpose of this guidance document is to identify the types of PMAs and BLAs subject to device user fees, including supplements and other submissions, as well as those that do not have an associated user fee. The guidance also identifies industry and FDA actions on these submissions that may result in a refund of the fee. The draft of this document was issued on March 16, 2009.

The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.

The Coast Guard proposes to establish a special local regulation on the waters of Charlotte Amalie Harbor in St Thomas, USVI during the St. Thomas Carnival Watersport Activities, a high speed boat race. The event is scheduled to take place on Sunday, April 21, 2013. Approximately 40 high-speed power boats will be participating in the races and it is anticipated that 50 spectator crafts will be present during the races. The special local regulation is necessary for the safety of race participants, participant vessels, spectators, and the general public during the event. The special local regulation will establish the following four areas: (1) A high speed boat race area, where all persons and vessels, except those persons and vessels participating in the high-speed boat races, are prohibited from entering, transiting through, anchoring in, or remaining within; (2) a jet ski race area, where all persons and vessels, except those persons and vessels participating in the jet ski races, are prohibited from entering, transiting through, anchoring in, or remaining within; (3) a buffer zone around the race areas, where all persons and vessels, except those persons and vessels enforcing the buffer zone or authorized participants transiting to their authorized the race area, are prohibited from entering, transiting through, anchoring in, or remaining within; and (4) a spectator area, where all vessels are prohibited from anchoring and from traveling in excess of wake speed, unless authorized by the Captain of the Port San Juan or a designated representative.

Public Law 105-220, the Workforce Investment Act (WIA), requires the Secretary of Labor (Secretary) to conduct reallotment of dislocated worker formula allotted funds based on State financial reports submitted as of the end of the prior program year (PY). This notice publishes the dislocated worker PY 2012 funds for recapture by State and the amount to be reallotted to eligible States.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the John E. Fogarty International Center, National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) 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 those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Dr. Rachel Sturke, Fogarty International Center, National Institutes of Health, 16 Center Drive, Building 16, Room 202, Bethesda, MD 20892, or call non-toll-free number 301-496-1491, or Email your request, including your address to: sturkerachel@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Evaluation of the Brain Disorders in the Developing World Program of the John E. Fogarty International Center, 0925-New, Fogarty International Center (FIC), National Institutes of Health (NIH). Need and Use of Information Collection: This study seeks to evaluate the management, effectiveness, and outcomes of the Brain Disorders in the Developing World extramural research program administered by the John E. Fogarty International Center of the NIH. The purpose of the Brain Disorders in the Developing World Program is to develop collaborative research and capacity building projects on brain disorders throughout life relevant to low- and middle-income countries. Awardees are expected to develop innovative projects that contribute to the long-term goal of building sustainable research capacity in nervous system function and impairment throughout life. Between FY 2003 and 2012, a total of 132 awards were made under the Brain Disorders program, and the total investment by Fogarty and its partners at NIH has been approximately $75 million. The findings of this evaluation study will provide valuable information concerning: (1) Whether and how the program has met its goal of supporting research and research capacity-building on brain disorders in low- and middle-income countries; (2) the extent to which the program as implemented functions efficiently and effectively; (3) the extent to which the program is consistent with the strategic priorities of Fogarty and its partners at NIH; (4) opportunities to improve upon the current implementation of the program if NIH chooses to continue supporting it; and (5) models, best practices, and lessons learned that may be applicable to other NIH programs, now and in the future. OMB approval is requested for 1 year. There are no costs to respondents other than their time. The total estimated annualized burden hours are 151.

This notice is issued in accordance with 51 U.S.C. 20144(c). The 2014 Night Rover Challenge is scheduled and teams that wish to compete may register. Centennial Challenges is a program of prize competitions to stimulate innovation in technologies of interest and value to NASA and the nation. The 2014 Night Rover Challenge is a prize competition designed to encourage development of new energy storage technologies or application of existing storage technologies in unique ways for application in extreme space environments. Competitors will need to demonstrate high energy density storage systems (>330w-hr/kg) that would enable a rover to operate throughout lunar darkness cycles. Cleantech Open of Palo Alto, California administers the Challenge for NASA. NASA is providing the $1,500,000 prize purse.

We propose to adopt a new airworthiness directive (AD) for certain General Electric Company (GE) GE90-76B, -85B, -90B, -94B, - 110B1, and -115B turbofan engines. This proposed AD was prompted by multiple reports of failure of certain stage 1 high-pressure turbine (HPT) stator shrouds due to accelerated corrosion and oxidation. This proposed AD would require initial and repetitive on-wing borescope inspections (BSIs) for corrosion and oxidation, of the affected stage 1 HPT stator shrouds, and removal from service before further flight, if the parts fail the inspection. We are proposing this AD to prevent failure of the stage 1 HPT stator shrouds, resulting in in-flight shutdown of one or more engines, loss of thrust control, and damage to the airplane.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.

EPA published a direct final rule, Greenhouse Gas Reporting Rule: Revision to Best Available Monitoring Method Request Submission Deadline for Petroleum and Natural Gas Systems Source Category, on February 19, 2013. That direct final rule amended the deadline by which owners or operators of facilities subject to the petroleum and natural gas systems source category of the Greenhouse Gas Reporting Rule are required to submit requests for use of best available monitoring methods (BAMM) to the Administrator. Because EPA received potentially adverse comments on the amendments in that direct final rule, we are issuing this notice to withdraw the direct final rule.

The Food and Drug Administration (FDA) is announcing that we have concluded that certain statements set forth in the FDA-approved labels of over-the-counter nicotine replacement therapy products, related to concomitant use with other nicotine-containing products and duration of use, can be modified. In light of currently available evidence, these statements are no longer believed to be necessary in their current form to ensure the safe and effective use of over-the- counter nicotine replacement therapy products for their approved intended use as aids to smoking cessation. We encourage the submission of supplemental new drug applications (labeling supplements) to modify these statements as described in this notice.

FMCSA announces its decision to exempt 19 individuals from its rule prohibiting persons with insulin-treated diabetes mellitus (ITDM) from operating commercial motor vehicles (CMVs) in interstate commerce. The exemptions will enable these individuals to operate CMVs in interstate commerce.

EPA is proposing to approve a revision to the State Implementation Plan (SIP) and Operating Permits Program to amend the definitions provisions of the rules. This SIP revision and revision to the Missouri operating permits program proposes to add the compounds propylene carbonate and dimethyl carbonate to the list of compounds which are excluded from the definition of Volatile Organic Compound (VOC) for consistency with the Federal definition of VOC. The SIP revision also proposes to correct two asbestos method subpart references. This revision also proposes approval of Missouri's request to amend the SIP to meet the 2008 fine particulate matter (PM2.5) National Ambient Air Quality Standards implementation requirements of the May 16, 2008, New Source Review (NSR) PM2.5 Rule. In this SIP revision, Missouri adopted rule revisions to establish the requirement for NSR permits to address directly emitted PM2.5 and precursor pollutants; and significant emission rates for direct PM2.5 and precursor pollutants (sulfur dioxide (SO2) and nitrogen dioxide (NOX)).

The EPA is finalizing its proposal to approve revisions to the Texas State Implementation Plan (SIP) for the Houston/Galveston/ Brazoria (HGB) 1997 8-Hour ozone nonattainment Area (Area). The HGB Area consists of Brazoria, Chambers, Fort Bend, Galveston, Harris, Liberty, Montgomery and Waller counties. Specifically, we are finalizing our proposed approval of portions of two revisions to the Texas SIP submitted by the Texas Commission on Environmental Quality (TCEQ) as meeting certain Reasonably Available Control Technology (RACT) requirements for Volatile Organic Compounds (VOC), and Oxides of Nitrogen (NOX) in the HGB Area. We are also finalizing our proposal to approve the 2007 Voluntary Mobile Emission Reduction Program (VMEP) commitments for the HGB Area. This action is in accordance with section 110 of the federal Clean Air Act (the Act, CAA).

The U.S. Department of Energy (DOE) proposes to establish test procedures for electrically-powered devices used in residential heating, ventilation, and air-conditioning (HVAC) products to circulate air through ductwork, hereafter referred to as ``furnace fans.'' DOE proposes a test procedure that would be applicable to furnace fans that are used in weatherized and non-weatherized gas, oil and electric furnaces and modular blowers, even though DOE interprets its authority as encompassing more than just circulation fans used in furnaces. This notice proposes to establish a test method for measuring the electrical consumption of the furnace fans used in these products. Concurrently, DOE is undertaking an energy conservation standards rulemaking to address the electrical energy used by these products for circulating air. Once these energy conservation standards are promulgated, the adopted test procedures would be used to determine compliance with the standards. DOE is also requesting written comments on issues presented in this test procedure rulemaking. DOE does not plan to hold a public meeting to discuss the modified proposals of this supplemental notice.