November 17, 2010 – Federal Register Recent Federal Regulation Documents

The Coast Guard is establishing a safety zone upon specified waters of the Potomac River. This action is necessary to provide for the safety of life on navigable waters during fireworks displays launched from a discharge barge located at National Harbor, in Prince Georges County, Maryland. This safety zone is intended to protect the maritime public in a portion of the Potomac River.

Pursuant to Section 14(a)(2)(A) of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C. App. 2), and 5 USC552b (c), and in accordance with Sec. 102-3.65, Title 41 of the Code of Federal Regulations, notice is hereby given that the Commercial Space Transportation Advisory Committee (COMSTAC) has been renewed for a 2- year period beginning November 17, 2010. The primary purpose of the Committee is to provide information, advice, and recommendations to the U.S. Department of Transportation (DOT) on matters concerning the U.S. commercial space transportation industry. The primary goals of the Committee are to evaluate economic, technological, and institutional developments relating to the industry; to provide a forum for the discussion of problems involving the relationship between industry activities and government requirements; and to make recommendations to DOT on issues and approaches for Federal policies and programs regarding the industry. The Committee will operate in accordance with the rules of the Federal Advisory Committee Act and the Department of Transportation, FAA Committee Management Order (1110.30C).

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on August 16, 2010 (75 FR 49938) and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: NIH NCI Central Institutional Review Board (CIRB). Type of Information Collection Request: Existing Collection in Use Without an OMB Number. Need and Use of Information Collection: The CIRB was created to reduce the administrative burden on local IRBs and investigators while protecting human research participants. To accomplish this, the CIRB uses several information collection tools to ensure that CIRB operations occur with high level of reviewer and board member satisfaction and is absent of conflicts of interest with the protocols under review. Tools utilized to accomplish this include the new member packets which are completed once a new member joins the CIRB to provide background information on workflow and processes of CIRB operations as well as a non-disclosure agreement. A conflict of interest form is completed occasionally or each time the reviewer is requested to serve as a reviewer for a study. CIRB helpdesk surveys measure satisfaction of helpdesk users and is conducted occasionally or each time the person contacts the helpdesk. Frequency of Response: Once, except for the SAE Reviewer Worksheet. Affected Public: Includes the Federal Government, business or other for-profits and not-for-profit institutions. Type of Respondents: Respondents include any customer who contacts the CIRB Helpdesk, institutional review board members and CIRB review participants. The annual reporting burden is estimated at 2209 hours (see Table 1 below for the estimated time burden). The total burden has decreased slightly as a result of corrected calculations from what was published in the 60-Day Federal Register Notice. The average annual cost to the government over a 12- month period is approximately $153,574 per year for a six year contract. This includes total annualized capital/start up costs of $25,108 and operating costs of $150,637.

The Maritime Administration and the U.S. Coast Guard announce they have received an application for the licensing of a natural gas deepwater port and the application contains the required information. This notice summarizes the applicant's plans and procedures that will be followed in considering the application.

Under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Regulatory Secretariat will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a currently approved information collection requirement concerning reporting purchases from sources outside the United States. Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of the FAR, and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.

The Environmental Technologies Trade Advisory Committee (ETTAC) was established under the Federal Advisory Committee Act, as amended, 5 U.S.C. App., and pursuant to Section 2313(c) of the Export Enhancement Act of 1988, as amended, 15 U.S.C. 4728(c). ETTAC was first chartered on May 31, 1994. By statute, the ETTAC advises, through the Secretary of Commerce, the Environmental Trade Working Group (ETWG) of the Trade Promotion Coordinating Committee (TPCC). The Secretary appoints the chair of the ETWG from among the employees of the Department. Although the ETWG is not currently active, the Department continues to function as chair of the ETWG, and the Department, as ETWG chair, utilizes the advice of the ETTAC and shares it with the TPCC or relevant TPCC member agencies as appropriate. ETTAC advises on the development and administration of policies and programs to expand U.S. exports of environmental technologies, goods, and services. The Department of Commerce rechartered the ETTAC on October 25, 2010 and is currently seeking nominations for membership on the ETTAC for the new charter term.

Under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35), agencies are required to submit proposed reporting and recordkeeping requirements to OMB for review and approval, and to publish a notice in the Federal Register notifying the public that the agency has made such a submission.

The Food and Drug Administration (FDA) is classifying the non- powered suction apparatus device intended for negative pressure wound therapy (NPWT) into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Class II Special Controls Guidance Document: Non-Powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy.'' The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability for the guidance document entitled ``Class II Special Controls Guidance Document: Non-Powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy.''

The National Aeronautics and Space Administration, 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 (Pub. L. 104-13, 44 U.S.C. 3506(c)(2)(A)).

In the Rules and Regulations section of this issue in the Federal Register, the IRS is issuing temporary regulations regarding status as a grandfathered health plan under the provisions of the Patient Protection and Affordable Care Act (the Affordable Care Act) in connection with changes in policies, certificates, or contracts of insurance. The temporary regulations provide guidance to employers, group health plans, and health insurance issuers providing group health insurance coverage. The IRS is issuing the temporary regulations at the same time that the Employee Benefits Security Administration of the U.S. Department of Labor and the Office of Consumer Information and Insurance Oversight of the U.S. Department of Health and Human Services are issuing substantially similar interim final regulations with respect to group health plans and health insurance coverage offered in connection with a group health plan under the Employee Retirement Income Security Act of 1974 and the Public Health Service Act. The text of the temporary regulations being issued by the IRS serves as the text of these proposed regulations.

This document contains an amendment to interim final regulations implementing the rules for group health plans and health insurance coverage in the group and individual markets under provisions of the Patient Protection and Affordable Care Act regarding status as a grandfathered health plan; the amendment permits certain changes in policies, certificates, or contracts of insurance without loss of grandfathered status.

We, the NMFS, have completed a comprehensive status review of the Hawaiian insular false killer whale (Pseudorca crassidens) under the Endangered Species Act (ESA) in response to a petition submitted by the Natural Resources Defense Council (NRDC) to list the Hawaiian insular false killer whale as an endangered species. After reviewing the best scientific and commercial information available, we have determined that the Hawaiian insular false killer whale is a distinct population segment (DPS) that qualifies as a species under the ESA. Moreover, after evaluating threats facing the species, and considering efforts being made to protect the Hawaiian insular DPS, we have determined that the DPS is declining and is in danger of extinction throughout its range. We propose to list it as endangered under the ESA. Although we are not proposing to designate critical habitat at this time, we are soliciting information to inform the development of the final listing rule and designation of critical habitat in the event the DPS is listed.

This document announces the second list of chemicals and substances for which EPA intends to issue test orders under the Endocrine Disruptor Screening Program (EDSP). EPA established the EDSP in response to section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA). This second list of chemicals expands the EDSP in an effort to include all pesticides, required by FFDCA, and adds priority drinking water chemicals into the program for screening as authorized by SDWA section 1457. Today's publication provides public notice of EPA's tentative decision-making in advance of the actual issuance of EDSP testing orders.

In compliance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), this document announces that EPA is planning to submit a request an addendum to an existing approved Information Collection Request (ICR) to the Office of Management and Budget (OMB). This addendum simply covers the burden for a new list of chemicals to receive and respond to EDSP Orders. The activities articulated in the original ICR are not changing. This ICR addendum, entitled ``Addendum for the Second List of Chemicals; Tier 1 Screening of Certain Chemicals Under the Endocrine Disruptor Screening Program (EDSP)'' and identified by EPA ICR No. 2249.02 and OMB Control No. 2070-0106. Before submitting the ICR to OMB for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection.

EPA issued a notice in the Federal Register of June 8, 2010 (75 FR 32463) (FRL-8827-5), concerning the Notice of Filing (NOF) for Pesticide Petition (PP) 0E7699 for polymerized fatty acid esters with aminoalcohol alkoxylates submitted by Exponent, on behalf of Croda. Although the NOF that appeared in the Federal Register was correct, there was a typographical error in the summary NOF that was placed in docket ID number: EPA-HQ-OPP-2010-0275. This document is being issued to announce that the Agency has placed a corrected summary NOF in the docket. Please see docket ID number EPA-HQ-OPP-2010-0275 for the corrected version.