Department of Health and Human Services August 20, 2014 – Federal Register Recent Federal Regulation Documents

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on May 13, 2014, page 27318, and allowed 60 days for public comment. The NIH received two requests to view the form and one comment expressing the opinion that chimpanzee research should be discontinued but did not receive any public comments on the form itself. The purpose of this notice is to allow an additional 30 days for public comment. The NIH Office of the Director (OD), Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments To OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the OMB Office of Regulatory Affairs at OIRA_ submission@omb.eop.gov; or by fax to 202-395-6974, Attention: NIH Desk Officer.

The Administration for Community Living (ACL) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to the Help America Vote Act (HAVA), Public Law 107-252, Title II, Subtitle D, Part 2, Sections 261 to 265 (HAVA Narrative Annual Report).

The Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) intends to provide a Single Source Cooperative Agreement Award to the National Academy of Science to establish a rapid and agile process for convening subject matter experts to address adverse health effects of public health emergencies and disasters when they occur. The goal of the process will be to prioritize scientific research needs in the immediate aftermath of a disaster that culminates in a summary report of the strategic science research questions most relevant to promote better response, recovery or enhanced resilience in the affect community. Research results would also inform response to the next disaster event. Subject matter expertise would vary, depending on the nature of the emergency/disaster. This could include experts with background in public health, epidemiology, environmental health, emergency management, first response, emergency medicine, infectious diseases, nursing, emergency management, bioethics, medical countermeasures, state and local government, operations research national civic organizations, and risk communication. The process convened by the Institute of Medicine (IOM) would also provide a connection to the local communities affected by the disaster, and include important stakeholders, such as non-government funders or other organizations. This cooperative Agreement will support ASPR's Government Performance and Results Act goals that ``HHS will work with its Federal, state, local, tribal, and international partners to build community resilience and strengthen health and emergency response systems. Robust systems are essential to a secure and resilient. Nation with required capabilities to prevent, protect against, mitigate, respond to, and recover from the threats and hazards that pose the greatest risk. This includes strengthening the Federal medical and public health response capability''. Scientific research involved with preparedness and response is a key component of this endeavor.

The Food and Drug Administration (FDA) has determined that LUPRON DEPOT-PED (leuprolide acetate for depot suspension), Injectable 3.75 milligrams (mg)/vial and 7.5 mg/vial; and LUPRON DEPOT-PED (leuprolide acetate for depot suspension), Injectable 7.5 mg/vial and 7.5 mg/vial, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for leuprolide acetate for depot suspension, injectable 3.75 mg/vial and 7.5 mg/vial; and injectable 7.5 mg/vial and 7.5 mg/vial, if all other legal and regulatory requirements are met. However, in considering whether to file an ANDA for leuprolide acetate for depot suspension, future applicants are advised that they may not be able to obtain LUPRON DEPOT-PED (leuprolide acetate for depot suspension), Injectable 3.75 mg/vial and 7.5 mg/vial; or LUPRON DEPOT-PED (leuprolide acetate for depot suspension), Injectable 7.5 mg/ vial and 7.5 mg/vial, for bioequivalence testing because the product has not been commercially available for a number of years. An ANDA applicant who is unable to obtain LUPRON DEPOT-PED (leuprolide acetate for depot suspension), Injectable 3.75 mg/vial and 7.5 mg/vial; or LUPRON DEPOT-PED (leuprolide acetate for depot suspension), Injectable 7.5 mg/vial and 7.5 mg/vial, for bioequivalence testing should contact the Office of Generic Drugs for a determination of what is necessary to show bioavailability and the same therapeutic effect.

The Indian Health Service published a document in the Federal Register on July 29, 2014, for the FY 2014 Office of Tribal Self- Governance Program, Planning Cooperative Agreement Announcement. The notice contained an incorrect date.

The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. Nominations will be accepted for current vacancies and for those that will or may occur through December 2014. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and therefore, encourages nominations of appropriately qualified candidates from these groups.