Department of Health and Human Services June 17, 2020 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 a generic clearance to collect information to support communications used by FDA about drug products.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on March 9, 2020. The document announced the withdrawal of approval (as of April 8, 2020) of 16 abbreviated new drug applications (ANDAs) from multiple applicants. The document indicated that FDA was withdrawing approval of the following four ANDAs after receiving a withdrawal request from Lupin Pharmaceuticals, Inc., 111 South Calvert St., Harborplace Tower, 21st Floor, Baltimore, MD 21202: ANDA 065488, Azithromycin Oral Suspension, Equivalent to (EQ) 100 milligrams (mg) base/5 milliliters (mL); EQ 200 mg base/5 mL; ANDA 078410, Topiramate Tablets, 25 mg, 50 mg, 100 mg, and 200 mg; ANDA 090441, Imipramine Hydrochloride Tablets, 10 mg, 25 mg, and 50 mg; and ANDA 200563, Ciprofloxacin Oral Suspension, 250 mg/5 mL and 500 mg/5 mL. Before FDA withdrew the approval of these ANDAs, Lupin Pharmaceuticals, Inc., informed FDA that it did not want the approval of the ANDAs withdrawn. Because Lupin Pharmaceuticals, Inc., timely requested that approval of these ANDAs not be withdrawn, the approval of ANDAs 065488, 078410, 090441, and 200563 is still in effect.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt Jakob Disease by Blood and Blood Components.'' The guidance provides blood establishments that collect blood and blood components with revised recommendations intended to reduce the possible risk of transmission of Creutzfeldt-Jakob disease (CJD) and variant Creutzfeldt-Jakob disease (vCJD) by blood and blood components. The recommendations in the guidance apply to the collection of Whole Blood and blood components intended for transfusion or for use in further manufacturing, including Source Plasma. The guidance finalizes the draft guidance of the same title dated January 2020, and supersedes 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,'' dated May 2010, and updated January 2016.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry, FDA staff, and other stakeholders entitled ``Patient-Focused Drug Development: Collecting Comprehensive and Representative Input.'' This guidance is the first of a series of four methodological guidance documents that FDA committed to develop to address in a stepwise manner how to collect and submit information from patients and caregivers for medical product development and regulatory decision making. This guidance finalizes the draft guidance of the same title issued on June 13, 2018.

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.