July 22, 2011 – Federal Register Recent Federal Regulation Documents

The Consumer Product Safety Commission (``CPSC,'' ``Commission,'' or ``we'') is amending its child-resistant packaging requirements to exempt powder formulations of two oral prescription drugs, colesevelam hydrochloride and sevelamer carbonate. Colesevelam hydrochloride, currently marketed as Welchol [supreg], is available in a powder formulation and is indicated to reduce elevated LDL cholesterol levels and improve glycemic control in adults with type 2 diabetes mellitus. Sevelamer carbonate, currently marketed as Renvela [supreg], is also available as a powder formulation and is indicated for the control of elevated serum phosphorus in chronic kidney disease patients on dialysis. The rule exempts these prescription drug products on the basis that child-resistant packaging is not needed to protect young children from serious injury or illness from powder formulations of colesevelam hydrochloride and sevelamer carbonate because the products are not acutely toxic, lack adverse human experience associated with acute ingestion, and, in powder form, are not likely to be ingested in large quantities by children under 5 years of age.

Pursuant to the provisions of the Privacy Act of 1974, as amended, the Department of the Interior is issuing a public notice of its intent to create the Department of the Interior system of records titled, Department of the Interior Social Networks. The system will assist the Department of the Interior by providing new ways to connect and share information, and solicit and receive feedback freely with the public. This newly established system will be included in the Department of the Interior's inventory of record systems.

The Federal Communications Commission, as part of its continuing effort to reduce paperwork burden invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s), as required by the Paperwork Reduction Act (PRA) of 1995, 44 U.S.C. 3501-3520. Comments are requested concerning: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimates; (c) ways to enhance the quality, utility, and clarity of the information collected; (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and (e) ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a valid OMB control number.

The Federal Communications Commission, as part of its continuing effort to reduce paperwork burden invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s), as required by the Paperwork Reduction Act (PRA) of 1995, 44 U.S.C. 35013520. Comments are requested concerning: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimate; (c) ways to enhance the quality, utility, and clarity of the information collected; (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and (e) ways to further reduce the information collection burden for small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a currently valid OMB control number.

The Department of Labor (DOL) is submitting the revised Wage and Hour Division (WHD) sponsored information collection request (ICR) titled, ``Application of the Employee Polygraph Protection Act,'' to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995 (Pub. L. 104-13, 44 U.S.C. chapter 35).

The Coast Guard proposes to establish a temporary safety zone on the waters of the New River, from Esplanade Park to the Henry Kinney Tunnel, in Fort Lauderdale, Florida during the Rotary Club of Fort Lauderdale New River Raft Race. The race is scheduled to take place on Saturday, November 19, 2011. The temporary safety zone is necessary for the safety of race participants, participant vessels, spectators, and the general public during the 550-yard raft race. Persons and vessels would be prohibited from entering, transiting through, anchoring in, or remaining within the safety zone unless authorized by the Captain of the Port Miami or a designated representative.

The U.S. Department of Agriculture (USDA) is amending the Guidelines for Designating Biobased Products for Federal Procurement, to add 14 sections to designate items within which biobased products will be afforded Federal procurement preference, as provided for under section 9002 of the Farm Security and Rural Investment Act of 2002, as amended by the Food, Conservation, and Energy Act of 2008 (referred to in this document as ``section 9002''). USDA is also establishing minimum biobased contents for each of these items.

The Pacific Fishery Management Council's (Pacific Council) ad hoc groundfish Essential Fish Habitat Review Committee (EFHRC) will hold a work session, which is open to the public, to plan the periodic 5-year review of groundfish Essential Fish Habitat (EFH).

The Food and Drug Administration (FDA) has determined that NUVIGIL (armodafinil) Tablets, 100 milligrams (mg) and 200 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for armodafinil tablets, 100 mg and 200 mg, if all other legal and regulatory requirements are met.

In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. The Federal Register Notice with a 60-day comment period soliciting comments on the following collection of information was published on May 25, 2011, vol. 76, no. 101, page 30421-30422. Part A of Subtitle VII of the Revised Title 49 U.S.C. authorizes the issuance of regulations governing the use of navigable airspace. Information is collected to determine compliance with Federal regulations. Respondents are individual airmen, state or local governments, and businesses.

This is a notice of the Presidential declaration of an emergency for the State of Nebraska (FEMA-3323-EM), dated June 18, 2011, and related determinations.

This is a notice of the Presidential declaration of a major disaster for the State of Idaho (FEMA-1987-DR), dated May 20, 2011, and related determinations.

This notice amends the notice of a major disaster declaration for the State of Indiana (FEMA-1997-DR), dated June 23, 2011, and related determinations.

This notice amends the notice of a major disaster declaration for the State of North Dakota (FEMA-1981-DR), dated May 10, 2011, and related determinations.