Orange Book-Questions and Answers; Draft Guidance for Industry; Availability

by the Food and Drug Administration on 06/01/2020.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Orange Book--Questions and Answers.'' This guidance is intended to assist interested parties (including prospective drug product applicants, drug product applicants, and approved application holders) in utilizing the...

Notice of Closed Meeting

by the Centers for Disease Control and Prevention on 06/01/2020.

Medicare and Medicaid Programs; Application From the Joint Commission (TJC) for Continued Approval of its Home Health Agency Accreditation Program; Correction

by the Centers for Medicare & Medicaid Services on 06/01/2020.

This document corrects technical errors that appeared in the notice published in the Federal Register on April 1, 2020 entitled ``Medicare and Medicaid Programs; Application from the Joint Commission (TJC) for Continued Approval of its Home Health Agency Accreditation Program.''

Submission for OMB Review: Title V State Sexual Risk Avoidance Education (SRAE) Program (New Collection)

by the Children and Families Administration on 06/01/2020.

The Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB) is accepting mandatory formula grant applications and State Plans from states and territories for the development of and implementation for Title V State Sexual Risk Avoidance Education (SRAE) Program. The Title V State SRAE Funding Opportunity...

Proprietary Names for New Animal Drugs; Guidance for Industry; Availability

by the Food and Drug Administration on 06/01/2020.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry #240 entitled ``Proprietary Names for New Animal Drugs.'' This guidance provides recommendations to help new animal drug sponsors develop proprietary names for new animal drugs that do not contribute to medication errors, negatively...

Notice of Approval of Product U nder Voucher: Rare Pediatric Disease Priority Review Voucher

by the Food and Drug Administration on 06/01/2020.

The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare...

Advisory Commission on Childhood Vaccines Meeting Cancellation

by the Health Resources and Services Administration on 06/01/2020.

This is to notify the public that the June 4, 2020, and June 5, 2020, meeting of the Advisory Commission on Childhood Vaccines (ACCV) is canceled.

Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; University Centers of Excellence in Developmental Disabilities Education, Research and Service Annual Report [OMB# 0985-0030]

by the Community Living Administration on 06/01/2020.

The Administration for Community Living (ACL) is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements...

Rare Disease Clinical Trial Networks; Request for Information and Comments

by the Food and Drug Administration on 06/01/2020.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the establishment of a docket to obtain information and comments from patients, patient advocates, the scientific community, health professionals, other regulatory and health authorities in the global community, regulated industry, and the general public regarding practical...

Approved Drug Products With Therapeutic Equivalence Evaluations (the “Orange Book”); Establishment of a Public Docket; Request for Comments

by the Food and Drug Administration on 06/01/2020.

The Food and Drug Administration (FDA or Agency) is announcing the establishment of a public docket to solicit comments on FDA's publication entitled ``Approved Drug Products With Therapeutic Equivalence Evaluations'' (commonly known as the ``Orange Book''). The Orange Book identifies drug products approved by FDA under the Federal Food, Drug,...

Listing of Patent Information in the Orange Book; Establishment of a Public Docket; Request for Comments

by the Food and Drug Administration on 06/01/2020.

The Food and Drug Administration (FDA or Agency) is announcing the establishment of a docket to solicit comments on the listing of patent information in the FDA publication, ``Approved Drug Products With Therapeutic Equivalence Evaluations'' (commonly known as the ``Orange Book''). We are soliciting comments on the types of patents currently...