Department of Health and Human Services January 19, 2018 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Draft Guidance for Industry and FDA Staff.'' The draft guidance, when finalized, establishes official guidance for industry and FDA staff regarding the use, content, and circumstances for issuance of public warnings and public notification of voluntary recalls under Federal regulations. The intent of the draft guidance is to increase and expedite the appropriate and accurate use of public warnings and public notification, to increase public health protection by better informing the public about violative products being recalled. The draft guidance clarifies and supplements existing policy for industry and FDA staff regarding the use of public warnings and public notification.

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for industry entitled ``Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application.'' This final guidance describes the conditions under which FDA does not intend to take action against a State-licensed pharmacy, a Federal facility, or an outsourcing facility that mixes, dilutes, or repackages certain biological products outside the scope of an approved biologics license application (BLA). It also describes the conditions under which FDA does not intend to take action when a State-licensed pharmacy, a Federal facility, an outsourcing facility, or a physician prepares prescription sets of allergenic extracts for subcutaneous immunotherapy.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' For a drug product compounded by an outsourcing facility to qualify for the exemptions under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), it must not be essentially a copy of one or more approved drug products and must meet other conditions in section 503B. This guidance sets forth FDA's policies concerning the ``essentially a copy'' provision of section 503B of the FD&C Act.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Material Threat Medical Countermeasure Priority Review Vouchers.'' There is stakeholder interest in FDA's implementation of the provision of the 21st Century Cures Act (Cures Act) that adds a new section to the Federal Food, Drug, and Cosmetic Act (FD&C Act) on priority review vouchers for material threat medical countermeasure applications. This new section of the FD&C Act makes provisions for awarding priority review vouchers for use with applications to sponsors of material threat medical countermeasure applications that meet the criteria specified by the FD&C Act. This draft guidance explains to internal and external stakeholders how FDA intends to implement the provisions of the new section of the FD&C Act.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56).'' This draft guidance describes the Agency's proposed approach regarding compliance with FDA's performance standards for laser products. FDA believes that under the circumstances described in this guidance, conformance with certain International Electrotechnical Commission (IEC) standards would provide adequate protection of the public health and safety for laser products similar to performance standards in FDA's regulations. Accordingly, FDA does not intend to consider whether firms that comply with the comparable IEC standards discussed in this guidance document also comply with performance standards in FDA's regulations. This draft guidance is not final nor is it in effect at this time.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

In accordance with the Federal Advisory Committee Act, this notice announces that the Centers for Disease Control and Prevention (CDC)/Health Resources and Services Administration (HRSA) Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment will hold a public meeting.