Department of Health and Human Services January 17, 2006 – Federal Register Recent Federal Regulation Documents

Federal grant applicants must complete a three-step registration process before applying for a federal grant opportunity through Grants.gov. Grants.gov is the federal government's free, single, and secure site for finding and submitting applications electronically for federal grant funding. It is part of the ongoing implementation of Electronic Government (E-Government) and a key component of the President's Management Agenda. Expanding electronic government makes it simpler for the public to receive high-quality services from the federal government in addition to improving the federal government's efficiency in the delivery of its services. To protect the applicant and the applicant's information, and to assure federal agencies that they are interacting with officials authorized to submit applications for funding on behalf of applicant entities, an applicant must register with Grants.gov. In fiscal year 2005, 20 out of 26 federal grant making departments and agencies achieved their goals, set through OMB guidance, of making 25 percent of their discretionary funding opportunities available for the electronic submission of applications on Grants.gov and over 15,000 applications were received. Per OMB milestones, in fiscal year 2006 the percentage of discretionary funding opportunities available for electronic submission will increase to 75 percent and then to 100 percent in fiscal year 2007. This planned increase in utilization of the Grants.gov system is indicative of a governmentwide transition to electronic grant processes. The twenty-six federal grant making departments and agencies participating in Grants.gov are: The Departments of Health and Human Services, Housing and Urban Development, Transportation, Education, Agriculture, Justice, Labor, Homeland Security, Defense, Commerce, Veterans Affairs, State, Treasury, Interior, and Energy, and the National Science Foundation, Environmental Protection Agency, National Aeronautics and Space Administration, National Endowment of the Arts, National Endowment of Humanities, Corporation for National & Community Service, U.S. Agency for International Development, National Archives and Records Administration, Small Business Administration, Institute of Museum and Library Services, and Social Security Administration. Each of the federal grant-making departments and agencies listed above are posting funding opportunities and grant application materials on Grants.gov. To facilitate the federal grant application process, this notice encourages prospective applicants to register early. Registering in advance of agencies posting their grant opportunities will eliminate many of the issues that applicants have faced by not meeting registration requirements in time to meet application deadlines. Registering early will allow the Federal agencies and Grants.gov sufficient time to address questions applicants may have in completing the registration process.

The Food and Drug Administration (FDA) is amending its current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most investigational ``Phase 1'' drugs from complying with the requirements in FDA's regulations. FDA will instead exercise oversight of production of these drugs under the agency's general statutory CGMP authority and investigational new drug application (IND) authority. In addition, FDA is making available simultaneously with the publication of this direct final rule, a guidance document setting forth recommendations on approaches to CGMP compliance for the exempted Phase 1 drugs. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule, under FDA's usual procedure for notice-and- comment rulemaking, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comments and withdraws this direct final rule. The companion proposed rule and direct final rule are substantively identical. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance for industry entitled ``INDs Approaches to Complying With CGMP During Phase 1'' to provide further guidance on the subject.

The Food and Drug Administration (FDA) is publishing this companion proposed rule to the direct final rule, published elsewhere in this issue of the Federal Register, which is intended to amend our current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most investigational ``Phase 1'' drugs from complying with the regulatory requirements. We will instead exercise oversight of production of these drugs under the agency's general statutory CGMP authority and investigational new drug application (IND) authority. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance for industry entitled ``INDsApproaches to Complying With CGMP During Phase 1'' to provide further guidance on the subject.