Department of Health and Human Services February 15, 2012 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) Detroit District Office, in co-sponsorship with the Society of Clinical Research Associates (SoCRA) is announcing a public workshop. The public workshop on FDA's clinical trial requirements is designed to aid the clinical research professional's understanding of the mission, responsibilities, and authority of FDA and to facilitate interaction with FDA representatives. The program will focus on the relationships among FDA and clinical trial staff, investigators, and institutional review boards (IRB). Individual FDA representatives will discuss the informed consent process and informed consent documents; regulations relating to drugs, devices, and biologics; as well as inspections of clinical investigators, IRB, and research sponsors. Date and Time: The public workshop will be held on May 9 and 10, 2012, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the Marriott Ann Arbor Ypsilanti at Eagle Crest, 1275 S. Huron St., Ypsilanti, MI 48197, 800-606-7044. Contact: Society of Clinical Research Associates (SoCRA), 530 West Butler Ave., Suite 109, Chalfont, PA 18914, 1-800-762-7292 or 215-822- 8644, FAX: 215-822-8633, email: SoCRAmail@aol.com, Web site: https:// www.SoCRA.org. (FDA has verified the Web site addresses throughout this document, but we are not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.); or Nancy Bellamy, Food and Drug Administration, Detroit District Office, 300 River Pl., Suite 5900, Detroit, MI 48207, 313-393-8143, Fax: 313- 393-8139, email: nancy.bellamy@fda.hhs.gov. Accommodations: Attendees are responsible for their own accommodations. Please mention SoCRA to receive the hotel room rate of $119 plus applicable taxes (available until April 17, 2012 or until the SoCRA room block is filled).

The Food and Drug Administration (FDA) 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 collection of information concerning class II special controls for an automated blood cell separator device operating by centrifugal or filtration separation principle.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.'' This draft guidance is intended to provide answers to common questions from sponsors interested in developing proposed biosimilar products, biologics license application (BLA) holders, and other interested parties regarding FDA's interpretation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

These regulations finalize, without change, interim final regulations authorizing the exemption of group health plans and group health insurance coverage sponsored by certain religious employers from having to cover certain preventive health services under provisions of the Patient Protection and Affordable Care Act.

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 National Practitioner Data Bank, 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 (established under section 1128E of the Social Security Act) and the National Practitioner Data Bank. Section 6403 of the Affordable Care Act requires the Secretary to establish a transition period to transfer all data in the Healthcare Integrity and Protection Data Bank to the National Practitioner Data Bank, and, once completed, to cease operations of the Healthcare Integrity and Protection Data Bank. Information previously collected and disclosed through the Healthcare Integrity and Protection Data Bank will then be collected and disclosed through the National Practitioner Data Bank. This regulatory action consolidates the collection and disclosure of information from both data banks into one part of the CFR.