Department of Health and Human Services June 7, 2018 – Federal Register Recent Federal Regulation Documents

With the successful completion of the 2016 Pill Image Recognition Challenge, the National Library of Medicine (NLM) gratefully acknowledges the pharmaceutical manufacturers, re-packagers, wholesalers, and retail and institutional pharmacies that submitted prescription drug products for imaging as part of its Computational Photography Project for Pill Identification (C3PI). Effective immediately, the NLM is concluding its collection of digital imagery of C3PI oral solid dosage formulations (OSDFs), discontinuing the program, and is no longer accepting prescription drug products for photography.

This request for information solicits public comment on a planned initiative of the Office of the Deputy Secretary of HHS to develop a workgroup to facilitate constructive, high-level dialogue between HHS leadership and those focused on innovating and investing in the healthcare industry. HHS seeks comment on how to structure a workgroup, or other form of interaction between the Department and such participants in the healthcare industry, in order to best support communication and understanding between these parties that will spur investment, increase competition, accelerate innovation, and allow capital investment in the healthcare sector to have a more significant impact on the health and wellbeing of Americans. HHS also seeks comment more broadly on opportunities for increased engagement and dialogue between HHS and those focused on innovating and investing in the healthcare industry.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Draft Guidance for Industry and Food and Drug Administration Staff.'' This draft guidance document provides an overview of the mechanisms available to applicants through which they can request feedback from or a meeting with FDA regarding potential or planned medical device investigational device exemption (IDE) applications, premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, evaluation of automatic class III designations (de novo requests), premarket notification (510(k)) submissions, Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application, Accessory Classification Requests, and certain investigational new drug (IND) applications and biologics license applications (BLAs). This draft guidance, when finalized, is intended to supersede the document entitled ``Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff'' issued on September 29, 2017. This draft guidance is not final nor is it in effect at this time.

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 the reporting requirements contained in the FDA collection of information ``Environmental Impact Considerations.''

The Food and Drug Administration (FDA) is announcing the renewal of the Pulmonary-Allergy Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Pulmonary- Allergy Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until May 30, 2020.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President's Emergency Plan for AIDS Relief.'' This draft guidance describes circumstances under which an applicant may be eligible for a barrier-to-innovation waiver for some new drug applications (NDAs) for fixed-combination versions and single- entity versions of previously approved antiretroviral therapies for the treatment of human immunodeficiency virus (HIV).

The Food and Drug Administration is correcting a proposed rule to amend its regulations concerning the classification of products as biological products, devices, drugs, or combination products, and their assignment to Agency components for premarket review and regulation that appeared in the Federal Register of May 15, 2018. The document was published with an error in the discussion of the preliminary economic analysis impact. This document corrects that error.