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# Federal Register Notices from Holiday Break
- URL: https://www.fdaweb.com/federal-register-notices-from-holiday-break/
- Published: 2024-01-02T12:00:00.000Z
- Updated: 2026-09-14T14:18:54.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5156058

**FDA Webview** has summarized below the *Federal Register* notices published during our holiday break.

**12/28/2023**

*Federal Register* notice: FDA is making available a draft guidance entitled “Potency Assurance for Cellular and Gene Therapy Products.” The document provides quality risk management recommendations to help assure the potency of human cellular therapy or gene therapy (CGT) products at all product lifecycle stages. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-12-28/pdf/2023-28596.pdf?ref=fdaweb.com).

*Federal Register* notice: FDA is making available a draft guidance entitled “Quality Considerations for Topical Ophthalmic Drug Products.” The document addresses microbiological considerations; approaches to evaluating visible particulate matter, extractables and leachables, and impurities and degradation products; use of *in vitro* drug release/dissolution testing as an optional quality control strategy for certain ophthalmic dosage forms; recommendations for design and delivery and dispensing features of container closure systems; and recommendations for stability studies. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-12-28/pdf/2023-28595.pdf?ref=fdaweb.com).

*Federal Register* notice: FDA is making available a final guidance entitled “Reformulating Drug Products That Contain Carbomers Manufactured with Benzene.” The document provides recommendations on what tests should be performed and what documentation should be submitted or available to support the reformulation of drug products that use carbomers manufactured with benzene. The agency says certain United States Pharmacopeia carbomer monographs currently allow for unacceptable levels of benzene, which raises safety concerns. The agency has requested that the monographs be removed, and applicants and manufacturers may need to reformulate their drug products to avoid use of these carbomers. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-12-28/pdf/2023-28675.pdf?ref=fdaweb.com).

*Federal Register* notice: FDA is making available version 2.3 of the Specifications for Preparing and Submitting Postmarket Individual Case Safety Reports (ICSRS) for Vaccines (Specifications). FDA says the document is not applicable to CBER-regulated drug products marketed for human use with approved NDAs/ANDAs; CBER-regulated therapeutic biological products marketed for human use with approved BLAs; whole blood or blood components; and human cells, tissues, and cellular and tissue-based products that are regulated solely under the Public Health Service Act. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-12-28/pdf/2023-28594.pdf?ref=fdaweb.com).

**12/27/2023**

*Federal Register* notice: FDA is making available a final guidance entitled “Direct- to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule: Questions and Answers.” To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-12-27/pdf/2023-28530.pdf?ref=fdaweb.com).

**12/26/2023**

*Federal Register* notice: FDA is making available a final guidance entitled “Rare Diseases: Considerations for the Development of Drugs and Biological Products.” The document is intended to assist rare disease product sponsors in conducting efficient and successful drug development programs through a discussion of selected issues commonly encountered in rare disease drug development. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-12-26/pdf/2023-28310.pdf?ref=fdaweb.com).

**12/22/2023**

*Federal Register* notice: FDA makes available a final guidance entitled “Data Standards for Drug and Biological Product Submissions Containing Real-World Data.” The document provides recommendations on submitting study data derived from real-world data sources in regulatory submissions using standards specified in the Data Standards Catalog. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-12-22/pdf/2023-28291.pdf?ref=fdaweb.com).

*Federal Register* notice: FDA is making available a final guidance entitled “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.” The document provides recommendations on the use of digital health technologies (DHTs) to acquire data remotely from participants in clinical investigations that evaluate medical products. DHTs for remote data acquisition in clinical investigations can include hardware or software to perform one or more functions. FDA says using DHTs as recommended in the guidance may improve clinical trial efficiency. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-12-22/pdf/2023-28262.pdf?ref=fdaweb.com).

*Federal Register* notice: FDA is making available a draft guidance entitled “Master Protocols for Drug and Biological Product Development.” The document discusses the design and analysis of trials conducted under a master protocol as well as the submission of documentation to support its review. It focuses on randomized umbrella and platform trials that are intended to contribute to demonstrating safety and substantial evidence of effectiveness. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-12-22/pdf/2023-28210.pdf?ref=fdaweb.com).

*Federal Register*: FDA is making available a final guidance entitled “Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products.” The document provides considerations for sponsors proposing to design a registry or to use an existing registry to support regulatory decision-making about a drug’s effectiveness or safety. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-12-22/pdf/2023-28289.pdf?ref=fdaweb.com).

*Federal Register* notice: FDA is making available a final guidance entitled “Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species.” The document is intended to assist those interested in pursuing FDA approval of new animal drugs intended for minor uses in major species or for use in minor species. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-12-22/pdf/2023-28287.pdf?ref=fdaweb.com).

**12/21/2023**

*Federal Register* final rule: FDA is issuing a final rule to implement a provision in the 21st Century Cures Act to allow an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of human subjects. It permits an institutional review board to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent for certain FDA-regulated minimal risk clinical investigations. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-12-21/pdf/2023-27935.pdf?ref=fdaweb.com).

*Federal Register* notice: FDA is seeking comments on a proposed information collection entitled “Examination of Implied Claims in Direct-to-Consumer Prescription Drug Promotion.” FDA says prior research has shown that implied claims are misremembered as explicit claims. The proposed research is intended to help the agency understand how consumers who self-report having been diagnosed with a target condition interpret implied claims in DTC prescription drug promotion, and how their perceptions differ from those of consumers who have not been diagnosed with the target condition. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-12-21/pdf/2023-28093.pdf?ref=fdaweb.com).

*Federal Register* notice: FDA is making available a draft guidance entitled “510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review.” The document provides FDA’s current thinking about the review program. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-12-21/pdf/2023-28095.pdf?ref=fdaweb.com).

*Federal Register* notice: FDA is making available a final guidance entitled “Development of Monoclonal Antibody Products Targeting SARS–CoV–2 for Emergency Use Authorization.” The document provides recommendations that focus on the data and information that may be used to support a request for emergency use authorization. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-12-21/pdf/2023-28092.pdf?ref=fdaweb.com).

**12/20/2023**

*Federal Register* notice: FDA is announcing the Web site address where it will post a list of possible topics for future guidance document development or revision by the Office of the Chief Scientist (OCS) during the next year. In addition, FDA has created a docket for providing comments that could benefit the OCS guidance program and its engagement with stakeholders, including comments on the priority of topics for guidance. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-12-20/pdf/2023-27967.pdf?ref=fdaweb.com).

**12/19/2023**

*Federal Register* notice: FDA is making available a final guidance entitled “Registration and Listing of Cosmetic Product Facilities and Products.” To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-12-19/pdf/2023-27649.pdf?ref=fdaweb.com).

*Federal Register* notice: FDA is making available a draft guidance entitled “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.” The document is intended\` to clarify how FDA evaluates medical device real-world data to determine whether they are of sufficient quality for generating real-world evidence that can be used in regulatory decision-making for medical devices. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-12-19/pdf/2023-27852.pdf?ref=fdaweb.com).

*Federal Register* notice: FDA is withdrawing approval of ANDAs from multiple applicants after they notified the agency that the drug products were no longer marketed and requested their withdrawal. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-12-19/pdf/2023-27853.pdf?ref=fdaweb.com).

*Federal Register* notice: FDA is issuing an order debarring **James Funaro** for five years from importing or offering for import any drug into the U.S. The order is based on his one felony count conviction for conspiracy to launder money that was related to a Web site that sold misbranded prescription drugs. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-12-19/pdf/2023-27854.pdf?ref=fdaweb.com).

*Federal Register* notice: FDA is issuing an order debarring **Jeremy Walenty** for five years from importing or offering for import any drug into the U.S. The order is based on his one felony count conviction for conspiracy to smuggle goods that was related to a Web site that sold misbranded prescription drugs. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-12-19/pdf/2023-27855.pdf?ref=fdaweb.com).