April 23, 2014 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations.'' The purpose of this guidance is to provide sponsors and manufacturers FDA's current thinking on the criteria by which two monoclonal antibody products would be considered the same under the Orphan Drug Act and implementing regulations.

The Food and Drug Administration (FDA) is announcing that Excentials B.V. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of L- selenomethionine as a dietary source of selenium in feed for poultry, swine, and ruminants.

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 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.

Pursuant to the Board's regulations, the Defense Nuclear Facilities Safety Board is publishing its proposed Freedom of Information Act (FOIA) Fee Schedule Update and solicits comments from interested organizations and individual members of the public.

Pursuant to the Council on Environmental Quality Regulations (40 CFR part 1500-08) implementing procedural provisions of the National Environmental Policy Act (NEPA), the Department of Labor, ETA, in accordance with 29 CFR 11.11(d), gives final notice of the proposed construction of the Medical/Dental Building at the Tongue Point Job Corps Center, and that this project will not have a significant adverse impact on the environment. Public scoping was initiated with a notice in the Daily Astorian in Astoria, Oregon on July 25, 2013. The scoping period extended for 30 days, ending on August 25, 2013. No public responses were received. No changes to the text of the environmental assessment (EA) have been made. Implementation of the selected alternative will not have significant impacts on the human environment. The determination is sustained by the analysis in the EA, agency consultation, the inclusion and consideration of public review, and the capability of mitigations to reduce or avoid impacts. Any adverse environmental impacts that could occur are no more than minor in intensity, duration and context and less-than-significant. As described in the EA, there are no highly uncertain or controversial impacts, unique or unknown risks, significant cumulative effects or elements of precedence. There are no previous, planned, or implemented actions, which in combination with the selected alternative would have significant effects on the human environment. Requirements of NEPA have been satisfied and preparation of an Environmental Impact Statement is not required.

Pursuant to the Council on Environmental Quality Regulations (40 CFR part 1500-08) implementing procedural provisions of the National Environmental Policy Act (NEPA), the Department of Labor, ETA, in accordance with 29 CFR 11.11(d), gives final notice of the proposed construction of the Phase II project at the Detroit Job Corps Center, and that this project will not have a significant adverse impact on the environment. Public scoping was initiated with a notice in the Southfield Sun in Detroit, Michigan on August 21, 2013. The scoping period extended for 30 days, ending on September 20, 2013. No public responses were received. No changes to the text of the environmental assessment (EA) have been made. Implementation of the selected alternative will not have significant impacts on the human environment. The determination is sustained by the analysis in the EA, agency consultation, the inclusion and consideration of public review, and the capability of mitigations to reduce or avoid impacts. Any adverse environmental impacts that could occur are no more than minor in intensity, duration and context and less-than-significant. As described in the EA, there are no highly uncertain or controversial impacts, unique or unknown risks, significant cumulative effects or elements of precedence. There are no previous, planned, or implemented actions, which in combination with the selected alternative would have significant effects on the human environment. Requirements of NEPA have been satisfied and preparation of an Environmental Impact Statement is not required.

The U.S. Nuclear Regulatory Commission (NRC) has recently submitted to OMB for review the following proposal for the collection of information under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). The NRC hereby informs potential respondents that an agency may not conduct or sponsor, and that a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The NRC published a Federal Register notice with a 60-day comment period on this information collection on December 30, 2013. 1. Type of submission, new, revision, or extension: Extension. 2. The title of the information collection: 10 CFR Part 19, ``Notices, Instructions, and Reports to Workers: Inspection and Investigations.'' 3. Current OMB approval number: 3150-0044. 4. The form number if applicable: Not applicable. 5. How often the collection is required: As necessary in order that adequate and timely reports of radiation exposure be made to individuals involved in applicable NRC-licensed activities. 6. Who will be required or asked to report: Licensees authorized to receive, possess, use, or transfer material licensed by the NRC. 7. An estimate of the number of annual responses: 1,426,121.8 responses (1,405,114.8 third-party disclosures + 7 reporting responses + 21,000 recordkeepers). 8. The estimated number of annual respondents: 21,000 (3,000 NRC licensees + 18,000 Agreement State licensees). 9. An estimate of the total number of hours needed annually to complete the requirement or request: 329,273.7. 10. Abstract: Part 19 of Title 10 of the Code of Federal Regulations (10 CFR), requires licensees to advise workers on an annual basis of any radiation exposure in excess of 1 mSv (100 mrem) they may have received as a result of NRC-licensed activities or when certain conditions are met. These conditions apply during termination of the worker's employment, at the request of the workers, former workers, or when the worker's employer (the NRC licensee) must report radiation exposure information on the worker to the NRC. Part 19 also establishes requirements for instructions by licensees to individuals participating in licensed activities and options available to these individuals in connection with Commission inspections of licensees to ascertain compliance with the provisions of the Atomic Energy Act of 1954, as amended, Title II of the Energy Reorganization Act of 1974, and regulations, orders and licenses there under regarding radiological working conditions. The worker should be informed of the radiation dose he or she receives because: (a) That information is needed by both a new employer and the individual when the employee changes jobs in the nuclear industry; (b) the individual needs to know the radiation dose received as a result of the accident or incident (if this dose is in excess of the 10 CFR Part 20 limits) so that he or she can seek counseling about future work involving radiation, medical attention, or both, as desired; and (c) since long-term exposure to radiation may be an adverse health factor, the individual needs to know whether the accumulated dose is being controlled within the NRC limits. The worker also needs to know about health risks from occupational exposure to radioactive materials or radiation, precautions or procedures to minimize exposure, worker responsibilities and options to report any licensee conditions which may lead to or cause a violation of Commission regulations, and individual radiation exposure reports which are available to him. The public may examine and have copied for a fee publicly-available documents, including the final supporting statement, at the NRC's Public Document Room, Room O-1F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. The OMB clearance requests are available at the NRC's Web site: https://www.nrc.gov/public-involve/doc-comment/omb/. The document will be available on the NRC home page site for 60 days after the signature date of this notice. Comments and questions should be directed to the OMB reviewer listed below by May 23, 2014. Comments received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given to comments received after this date. Danielle Y. Jones, Desk Officer, Office of Information and Regulatory Affairs (3150-0044), NEOB-10202, Office of Management and Budget, Washington, DC 20503. Comments can also be emailed to Danielle_Y_Jones@omb.eop.gov or submitted by telephone at 202-395-1741. The Acting NRC Clearance Officer is Kristen Benney, telephone: 301- 415-6355.

The Food and Drug Administration (FDA or the Agency) is announcing the availability of the draft guidance entitled ``Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval.'' This draft guidance clarifies FDA's current policy on balancing premarket and postmarket data collection during the Agency's review of premarket approval applications (PMA). Specifically, this guidance outlines how FDA considers the role of postmarket information in determining the appropriate type and amount of data that should be collected in the premarket setting to support premarket approval, while still meeting the statutory standard of safety and effectiveness. FDA believes this guidance will improve patient access to safe and effective medical devices that are important to public health by improving the predictability, consistency, transparency, and efficiency of the premarket process. This draft guidance is not final nor is it in effect at this time.

As part of the Transparency Initiative, the Food and Drug Administration (FDA) is announcing the availability of a report entitled ``Food and Drug Administration Transparency Initiative: Increasing Public Access to FDA's Compliance and Enforcement Data.'' This report summarizes findings and recommendations from eight FDA working groups established to enhance the transparency and public accessibility of the Agency's compliance and enforcement data.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Phase II of a Longitudinal Program Evaluation of Health and Human Services (HHS) Healthcare Associated Infections (HAI) National Action Plan (NAP).'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.

The U.S. Department of the Treasury 's Office of Foreign Assets Control (``OFAC'') is publishing the name of one individual whose property and interests in property has been blocked pursuant to the Foreign Narcotics Kingpin Designation Act (``Kingpin Act'') (21 U.S.C. 1901-1908, 8 U.S.C. 1182).

The Department of Transportation (DOT) invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. We are required to publish this notice in the Federal Register by the Paperwork Reduction Act of 1995, Public Law 104-13.