Department of Health and Human Services December 22, 2017 – Federal Register Recent Federal Regulation Documents

On Wednesday, December 13, 2017, the Centers for Medicare & Medicaid Services (CMS) published a notice document entitled, ``Agency Information Collection Activities: Submission for OMB Review; Comment Request''. That notice invited public comments on two separate information collection requests, under Document Identifiers: CMS-R-262 and CMS-10398. Through the publication of this document, we are withdrawing the portion of the notice requesting public comment on the information collection request titled, ``Contract Year 2019 Plan Benefit Package (PBP) Software and Formulary Submission.'' The associated form number is CMS-R-262 (OMB control number: 0938-0763). The comment period for CMS-10398 (OMB control number: 0938-1148) titled, ``Generic Clearance for Medicaid and CHIP State Plan, Waiver, and Program Submissions'' remains in effect and ends on January 12, 2018.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Draft Guidance for Industry.'' The draft guidance is intended to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application (BLA). The draft guidance provides applicants and manufacturers general and administrative information on reporting and evaluating changes and recommendations for reporting categories based on a tiered-reporting system for specific changes. The draft guidance, when finalized, is intended to supersede the document entitled ``Guidance for Industry: Changes to an Approved Application: Biological Products'' dated July 1997 (July 1997 guidance).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Amendment to `Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry;' Draft Guidance for Industry.'' The draft guidance document provides blood collection establishments with revised recommendations intended to reduce the possible risk of transmission of variant Creutzfeldt-Jakob Disease (vCJD) by blood and blood products by revising and removing certain recommended deferrals for geographic risk of bovine spongiform encephalopathy (BSE) exposure and recommending deferral for individuals with a history of blood transfusion in Ireland from 1980 to the present. The recommendations apply to the collection of Whole Blood and blood components intended for transfusion or for use in further manufacturing into injectable and non-injectable products, including recovered plasma, Source Leukocytes and Source Plasma. The draft guidance, when finalized, will amend the document entitled ``Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry'' updated January 2016 (``2016 vCJD Guidance'') by incorporating into an updated final guidance any new recommendations adopted. All other recommendations in the 2016 vCJD Guidance will remain unchanged.

The Food and Drug Administration (FDA or Agency), in collaboration with the Clinical Trials Transformation Initiative (CTTI), is requesting nominations of patient advocates interested in participating on the Patient Engagement Collaborative (PEC). The PEC will be an ongoing, collaborative forum coordinated through the Patient Affairs Staff, Office of Medical Products and Tobacco (OMPT), Office of the Commissioner, and will be hosted by CTTI. Through the PEC, the patient community and regulators will be able to discuss an array of topics regarding increasing meaningful patient engagement in medical product development and regulatory discussions at FDA. The activities of the PEC may include, but are not limited to, providing diverse perspectives on topics such as systematic patient engagement, transparency, and communication; providing considerations for implementing new strategies to enhance patient engagement at FDA; and proposing new models of collaboration in which patients and patient advocates are partners in certain aspects of the medical product development and FDA review process.