Department of Health and Human Services April 2014 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) has determined the regulatory review period for ONSIOR and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that animal drug product.

The Food and Drug Administration (FDA) has determined the regulatory review period for POTIGA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA or Agency) has determined that NIMOTOP (Nimodipine) Capsules, 30 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of the abbreviated new drug applications (ANDAs) that refer to nimodipine capsules, 30 mg, and it will allow FDA to approve ANDAs that refer to this drug as long as they meet relevant legal and regulatory requirements.

The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Guidance for Industry on Bioequivalence Recommendations for Specific Products; Availability,'' which explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.

The Administration for Community Living (ACL) is announcing the application deadline and a single case deviation from maximum competition for the National Legal Assistance and Support grants under Section 420(a)(1) of the Older Americans Act (OAA) that constitute the National Legal Resource Center (NLRC). The NLRC program provides resource support to a national system of legal assistance and elder rights programs to improve the quality, cost effectiveness, and accessibility of legal assistance and elder rights protections provided to older people. The purpose of this deviation is to award a 4th year non-competing continuation to the NLRC project grantees with a three (3) year budget period set to expire May 31, 2014 so that: (1) Stakeholder input can be obtained on the resource support needs of legal and aging/disability service providers across the country; and (2) the current work under the NLRC can be better directed to support and advance ACL activities anticipated in FY15 in the area of elder rights and elder abuse prevention. Program Name: National Legal Assistance and SupportNational Legal Resource Center. Award Amount: $655,462 ($143,347 to $185,693 per grantee). Project Period: 6/1/2011 to 5/31/2015. Award Type: Cooperative Agreement.

In compliance with the requirement of Section 3506(c) (2) (A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Office of Intramural Research (OIR), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Mr. Larry Chloupek, Management Liaison Director, OIR, Office of the Director, NIH, 2 Center Drive MSC 0235, Bethesda, MD 20892-0235; or call non- toll-free number 301-594-3992; or email your request, including your address, to larry.chloupek@nih.gov. Formal requests for additional plans and instruments must be requested in writing.

The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.workplace.samhsa.gov.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act.'' The guidance is intended for entities that compound human drugs and elect to register as outsourcing facilities (outsourcing facility) under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as added by the Drug Quality and Security Act (DQSA). Entities that elect to register as outsourcing facilities must pay certain fees to be considered outsourcing facilities. This guidance describes the annual establishment fee, the reinspection fee, annual adjustments to fees required by law, how to submit payment, the effect of failure to pay fees, and how to qualify as a small business to obtain a reduction of the annual establishment fee.