October 26, 2007 – Federal Register Recent Federal Regulation Documents

The Mid-Atlantic Fishery Management Council's (Council) Summer Flounder Monitoring Committee, Scup Monitoring Committee, Black Sea Bass Monitoring Committee, and the Mid-Atlantic Fishery Council's and the Atlantic States Marine Fisheries Commission's Summer Flounder, Scup, and Black Sea Bass Advisors will hold public meetings.

Notice is hereby given that the National Science Foundation (NSF) has received a waste management permit application for operation of a remote field support and emergency provisions helicopter flight seeing for the Motor Vessel, Octopus for the 2006-2007 austral summer season. The application is submitted to NSF pursuant to regulations issued under the Antarctic Conservation Act of 1978.

This action adds to the Procurement List a service to be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.

The Powder River Regional Coal Team (RCT) has scheduled a public meeting for December 6, 2007, to review current and proposed activities in the Powder River Coal Region and to review pending coal lease applications (LBA).

We are reopening the comment period for our proposed rule that would amend the regulations on importing nursery stock by providing a new option for the postentry quarantine growing period for articles of Chrysanthemum spp., Leucanthemella serotina, and Nipponanthemum nipponicum and amending the definition of from. This action will allow interested persons additional time to prepare and submit comments.

The United States Mint is adopting a new rule establishing procedures under which the United States Mint will implement and execute the provisions of 31 U.S.C. 333(c), which authorizes the Secretary of the Treasury to assess a civil penalty against any person who has misused the words, titles, abbreviations, initials, symbols, emblems, seals, or badges of the United States Mint.

The Office for Human Research Protections (OHRP) is requesting written comments on a proposed amendment to item 5 of the categories of research that may be reviewed by the institutional review board (IRB) through an expedited review procedure, last published in the Federal Register on November 9, 1998 (63 FR 60364). On that date, the Office for Protection from Research Risks (OPRR), now OHRP, and the Food and Drug Administration (FDA) simultaneously published identical lists of categories of research activities involving human subjects which may be reviewed by the IRB through an expedited review procedure. It has come to OHRP's attention that there has been confusion in the research community about expedited review category 5. OHRP is proposing to amend expedited review category 5 to clarify that the category includes research involving materials that were previously collected for either nonresearch or research purposes, provided that any materials collected for research were not collected for the currently proposed research. Expedited review category 5 also includes research involving materials that will be collected solely for nonresearch purposes. In addition, OHRP is requesting comments on the entire expedited review list that was last published in the Federal Register on November 9, 1998 (63 FR 60364) to determine if other changes are needed. As part of its charge to provide expert advice and recommendations to the Secretary of Health and Human Services (the Secretary) and the Assistant Secretary for Health on issues and topics pertaining to or associated with the protection of human research subjects, the Secretary's Advisory Committee on Human Research Protections (SACHRP), through its Subcommittee on Subpart A, considered whether the current expedited review categories should be modified. On March 14, 2007, SACHRP submitted recommendations regarding expedited review to the Secretary, and on June 18, 2007, the Secretary sent a letter to the SACHRP chairperson, stating that HHS would give serious consideration to these recommendations. In regard to the current expedited review categories, SACHRP recommended that expedited review category 7 should be revised as described in Section V below. Therefore, in addition to requesting comments on the entire expedited review list that was published in the Federal Register on November 9, 1998 (63 FR 60364), OHRP is also specifically requesting comments on SACHRP's recommended revision of expedited review category 7. As required under 21 CFR 56.110(a), FDA also will publish in the Federal Register a list of categories of research that may be reviewed by the IRB through an expedited review procedure. FDA intends to issue the list concurrently with OHRP's issuance of its final notice, and in compliance with 21 CFR 10.115 (good guidance practice regulations). This approach maintains FDA's practice of moving in tandem on this issue with OHRP.