February 11, 2015 – Federal Register Recent Federal Regulation Documents

The Federal Motor Carrier Safety Administration (FMCSA) renews an exemption that allows commercial motor vehicle operators to use trailer-mounted electric brake controllers which monitor and actuate electric trailer brakes based on inertial forces developed in response to the braking action of the towing vehicle. The Agency has concluded that granting this exemption renewal to allow the use of trailer- mounted electric brake controllers will maintain a level of safety that is equivalent to, or greater than, the level of safety achieved without the exemption. However, the Agency requests comments on this issue, especially from anyone who believes this standard will not be maintained.

FMCSA announces its decision to renew the exemptions from the vision requirement in the Federal Motor Carrier Safety Regulations for 9 individuals. FMCSA has statutory authority to exempt individuals from the vision requirement if the exemptions granted will not compromise safety. The Agency has concluded that granting these exemption renewals will provide a level of safety that is equivalent to or greater than the level of safety maintained without the exemptions for these commercial motor vehicle (CMV) drivers.

The Food and Drug Administration (FDA or Agency) is announcing a public meeting and an opportunity for public comment on Patient- Focused Drug Development for functional gastrointestinal (GI) disorders, including irritable bowel syndrome, gastroparesis, chronic persistent symptomatic gastroesophageal reflux despite standard therapeutic interventions, and chronic idiopathic constipation. Patient-Focused Drug Development is part of FDA's performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patient perspectives on the impact of functional GI disorders on daily life and patient views on treatment approaches.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Safety Considerations to Mitigate the Risks of Misconnections with Small-Bore Connectors Intended for Enteral Applications.'' The use of common connector designs, such as Luer connectors, has led to unintended connections between devices that have different intended uses and has resulted in serious and sometimes fatal consequences to patients. This guidance provides recommendations to manufacturers regarding the expectations for design and testing of small-bore connectors intended for enteral applications (``enteral devices''). FDA is making these recommendations to reduce the risk of unintended connections between enteral and non- enteral devices.

The Department of the Navy published a document in the Federal Register (80 FR 5098) of January 30, 2015, concerning the U.S. Naval Academy Board of Visitors meeting on March 2, 2015 in which the executive session of this meeting will be closed from 11:00 a.m. to 12:00 p.m. The document contained an incorrect approving authority.

The Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS) announces an opportunity for industry and the public to collaborate on a project to evaluate simplified nucleic acid tests. HHS/CDC is interested in evaluating simplified nucleic acid tests that (1) can be used near a patient with rapid turn-around of results (2) can be used to aid in the diagnosis of HIV-1 infection, and (3) have the potential to be used in moderately complex and/or waived laboratories as defined under the Clinical Laboratory Improvement Amendment (CLIA) regulations. Tests of interest include those that use whole blood, serum, plasma, or dried blood spots. Performance will be evaluated relative to HHS/Food and Drug Administration (FDA)-approved qualitative and quantitative nucleic acid tests as well as antibody immunoassays. More than one collaborator may be selected.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

We, the U.S. Fish and Wildlife Service (Service), announce a public meeting of the Sport Fishing and Boating Partnership Council (Council). A Federal advisory committee, the Council was created in part to foster partnerships to enhance public awareness of the importance of aquatic resources and the social and economic benefits of recreational fishing and boating in the United States. This meeting is open to the public, and interested persons may make oral statements to the Council or may file written statements for consideration.

Notice is hereby given that the U.S. International Trade Commission has determined to review-in-part the final initial determination issued by the presiding administrative law judge (``ALJ'') in the above-captioned investigation on December 5, 2014. The Commission requests certain briefing from the parties on the issues under review, as indicated in this notice. The Commission also requests briefing from the parties and interested persons on the issues of remedy, the public interest, and bonding.

As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: 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; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; 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 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 PRA that does not display a valid OMB control number.

The Copyright Royalty Judges solicit comments on a motion of Phase I claimants for partial distribution of 2013 satellite royalty funds.

Notice is hereby given, pursuant to CBP regulations, that Coastal Gulf and International, Inc., has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of August 19, 2014.

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, Grants.gov (EGOV), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for reinstatement of a previously-approved information collection assigned OMB control number 4040-0016SF-429 Real Property Status Report, which expired on July 31, 2014. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Prior to submitting that ICR to OMB, EGOV seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, Grants.gov (EGOV), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for issuance of a new expiration date of a previously-approved information collection assigned OMB control number 4040-0014SF-425 Federal Financial Report, which expires on February 28, 2015. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Prior to submitting that ICR to OMB, EGOV seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, Grants.gov (EGOV), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for reinstatement of a previously-approved information collection assigned OMB control number 4040-0012-SF-270: Request for Advance or Reimbursement, which expired on October 31, 2013. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Prior to submitting that ICR to OMB, EGOV seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, Grants.gov (EGOV), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for a 3 year renewal of a previously-approved information collection assigned OMB control number 4040-0006SF-424 D Assurances for Construction Programs, which expired on June 30, 2014. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Prior to submitting that ICR to OMB, EGOV seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, Grants.gov (EGOV), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for a 3 year renewal of a previously-approved information collection assigned OMB control number 4040-0008SF-424 C Budget Information for Construction Programs, which expired on June 30, 2014. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Prior to submitting that ICR to OMB, EGOV seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The Small Business Administration (SBA) intends to request approval, from the Office of Management and Budget (OMB) for the collection of information described below. The Paperwork Reduction Act (PRA) of 1995, 44 U.S.C. chapter 35 requires federal agencies to publish a notice in the Federal Register concerning each proposed collection of information before submission to OMB, and to allow 60 days for public comment in response to the notice. This notice complies with that requirement.

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, Grants.gov (EGOV), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for reinstatement of a previously-approved information collection assigned OMB control number 4040-0003SF424 Short Organizational, which expired on July 30, 2011. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Prior to submitting that ICR to OMB, EGOV seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.