Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Manufactured Food Regulatory Program Standards
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers; Draft Guidance for Industry and Food and Drug Administration Staff; Extension of Comment Period
The Food and Drug Administration (FDA or we) is extending the comment period for the document entitled ``Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers; Draft Guidance for Industry and Food and Drug Administration Staff,'' that appeared in the Federal Register of May 13, 2016. In the document, FDA requested comments on FDA's recommendations to assist industry in designing studies to establish the analytical and clinical performance characteristics of infectious disease next generation sequencing-based diagnostic devices for microbial identification and detection of antimicrobial resistance and virulence markers. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2017; Corrections
This document corrects technical and typographical errors that appeared in the final rule published in the March 8, 2016 Federal Register (81 FR 12204 through 12352) entitled ``Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2017.'' The effective date for the rule was May 9, 2016.
National Institute for Occupational Safety and Health Draft Immediately Dangerous to Life or Health (IDLH) Value Profile for Peracetic Acid (CAS #79-21-0)
On May 1, 2015, the Director of the National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), published a notice in the Federal Register [80 FR 24930] announcing the availability of and a request for comments for the draft immediately dangerous to life or health (IDLH) values and support technical documents, entitled IDLH Values Profiles, for 14 chemicals. Written comments were to be received before the end of the comment period on June 30, 2015. Due to subsequent requests from the public, this Notice announces that NIOSH is seeking further comments on the draft IDLH Value Profile for peracetic acid (CAS #79- 21-0) http://www.cdc.gov/niosh/docket/review/docket156a/pdfs/g1-013 - peracetic-acid-cas-79-21-0.pdf for an additional 60 days.
New Animal Drug Applications; Contents of Notice of Opportunity for a Hearing; Correction
The Food and Drug Administration (FDA, the Agency, or we) is making technical corrections to its regulations for hearing procedures for denial of approval or withdrawal of approval of new animal drug applications. The Agency is taking this action to harmonize terminology and to improve the organization and clarity of the regulations.
Regulatory Hearing Before the Food and Drug Administration; General Provisions; Technical Amendment
The Food and Drug Administration (FDA) is amending its regulations to correct an error in the lists of statutory and regulatory provisions that provide an opportunity for an informal hearing so that the lists correctly reference the statutory and regulatory provisions that provide such an opportunity in connection with a ban of a device. This action is being taken to align the regulations with the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and avoid any potential confusion the erroneous lists may cause.
Medicare Program; Administrative Law Judge Hearing Program for Medicare Claim and Entitlement Appeals; Quarterly Listing of Program Issuances-March Through June 2016
This quarterly notice lists the OMHA Case Processing Manual (OCPM) manual instructions that were published from March through June, 2016. This manual standardizes the day-to-day procedures for carrying out adjudicative functions, in accordance with applicable statutes, regulations and OMHA directives, and gives OMHA staff direction for processing appeals at the OMHA level of adjudication.