debarment certification fda

• Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions

The Regulatory Flexibility Act requires that agencies publish semiannual regulatory agendas in the Federal Register describing regulatory actions they are developing that may have a significant economic impact on a substantial number of small entities (5 U.S.C. 602). Executive Order 12866 ``Regulatory Planning and Review,'' signed September 30, 1993 (58 FR 51735), and Office of Management and Budget memoranda implementing section 4 of that Order establish minimum standards for agencies' agendas, including specific types of information for each entry. The Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda) helps agencies fulfill these requirements. All Federal regulatory agencies have chosen to publish their regulatory agendas as part of the Unified Agenda. Edi...

... of automatic enrollment, direct certification, or reduced paperwork burdens. Science. Agenc... and Debarment. 2700-AD82..................... NASA, Contract. ...

• Federal Register Nbr. 77 FR 7664, February 13, 2012
• Proposed rules
• Regulatory Information Service Center

• National Practitioner Data Bank

This proposed rule revises existing regulations under sections 401-432 of the Health Care Quality Improvement Act of 1986 and section 1921 of the Social Security Act, governing the , to incorporate statutory requirements under section 6403 of the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act), Public Law 111-148. The Department of Health and Human Services (HHS) also is removing Title 45 of the Code of Federal Regulations (CFR) part 61, which implemented the Healthcare Integrity and Protection Data Bank. Section 6403 of the Affordable Care Act, the statutory authority for this regulatory action, was designed to eliminate duplicative data reporting and access requirements between the Healthcare Integrity and Protection Data Bank (e...

... Enforcement Administration (DEA) certification actions; Medicare/Medicaid exclusions; and medical... means a temporary or permanent debarment of an individual or entity from participation in a...

• Federal Register Nbr. 77 FR 9138, February 15, 2012
• Proposed rules
• Health and Human Services Department

• Carroll Kisser v. Henry G. Cisneros, Secretary of U.S. Department of Housing and Urban Development, Et Al., Appellants., 14 F.3d 615 (D.C. Cir. 1994)

... Secretary's designee sustaining HUD's debarment decision. We reverse. I. Factual Background. In Ja..., evaluation, and determination" for certification for future participation); 200.230 (allowing "sign...

• Federal Circuits

• Part II

... present a means to provide FDA with certification that any of the indicated persons (i.e., submitter...335a, FDA can seek debarment of any person who has been convicted of a felony r...

• FR, November 07, 2008
• Separate parts
• Health and Human Services Department, Food and Drug Administration

• 7 CFR 246.4 - State plan.

...The manual shall include?. (i) Certification procedures, including:. (A) A list of the specific... CFR part 3017 regarding nonprocurement debarment/suspension. (24) A description of the State agency...

• Code of Federal Regulations - Title 7: Agriculture

• Debarment Orders:

... claim forms which included his certification that all of the information on the claim forms was...

• FR, December 17, 2010
• Notices
• Food and Drug Administration

• Office of the Commissioner Reorganization; Statement ofOrganizations, Functions, and Delegations of Authority

... limited to, requests for hearings in debarment and disqualification proceedings, requests to revi..., implementation or electronic certification for treasury schedules expansion of lock box techn...

• FR, August 18, 2009
• Notices
• Food and Drug Administration

• Reports and guidance documents; availability, etc.: Debarment certification statements submission; industry guidance,

• FR, October 02, 1998
• Notices
• Food and Drug Administration

• Part II

...Federal-Wide and HHS Acquisition Certification Programs. The HHSAR coverage in Subpart 301.6 of r...Subpart 309.4--Debarment, Suspension, and Ineligibility. Sec. 309.403 Defin...

• FR, November 27, 2009
• Separate parts
• Health and Human Services Department

• Reports and guidance documents; availability, etc.: Guidance documents; annual list,

... Qualification Worksheet and Certification--8/20/ 2004 Guidance for Industry: Independent Con... Draft Guidance for Industry: Submitting Debarment Certification Statements--10/2/1998 ICH Guidance o...

• FR, March 28, 2006
• Notices
• Food and Drug Administration