FDA-TRACK: Unified Agenda-TRACK
Regulations specify the details and requirements necessary to implement and to enforce legislation enacted by Congress. Because of their importance, an agency’s rulemaking plans are of great interest to a wide range to stakeholders. Therefore, the Federal Government publishes a semi-annual agenda of upcoming regulations in the Federal Register, usually in the Spring and Fall. On this Web page, we will maintain an updated agenda of the agency’s upcoming rulemakings.
Click here for more information on the process the agency follows to issue Rules & Regulations.
If a regulation is reported in the “Notes” column of the table as being “Accepted for Review by OMB,” this means it has been accepted by the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget for review under Executive Order 12866. To see a list of all rulemakings accepted by OIRA for a regulatory review, please visit the OMB Dashboard.
| Formal Title | RIN | Stage | Abstract | Legal Deadline | Projected Publication Date | FDA Lead Organization | Notes |
|---|---|---|---|---|---|---|---|
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Regulation of Flavors in Tobacco Products; Request for Information |
ANPRM |
Evidence shows that flavored tobacco products, especially those that are sweet or are described with terms attractive to kids, appeal to youth and also shows that youth may be more likely to initiate tobacco use with such products. Evidence also shows that the presence of flavors in some non-combustible tobacco products may play a role in helping some tobacco users transition away from combusted tobacco products, which are likely the most harmful currently marketed form of nicotine delivery for an individual user. This Advance Notice of Proposed Rulemaking will seek information on how it might regulate flavors in tobacco products to limit appeal to youth while taking into account the potential role that some flavors may play in helping some users transition away from combusted products. Certain flavors are generally recognized as appealing to youth, such as gummy bear and cotton candy, while others, such as coffee and cinnamon, may not be as obvious. In this notice, FDA would request information on how best to regulate flavors in tobacco products to limit appeal to youth and prevent youth initiation and use of tobacco products.. |
None |
5/31/2018 |
CTP |
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Tobacco Product Standard for Nicotine Level of Certain Tobacco Products; Request for Information |
0910-AH86 |
ANPRM |
This ANPRM would explain that FDA is considering whether it would be appropriate to develop a product standard that would set a maximum nicotine level in certain combusted tobacco products so that they are minimally addictive. Such a standard, if ultimately promulgated, could help limit the addictiveness of the most toxic and widely used tobacco products, which would have significant public health benefits for youth, young adults, and adults, as well as potentially vast economic benefits. This ANPRM would request comments, data, research results, and other information that could inform regulatory actions FDA might take with respect to the nicotine level of certain combusted tobacco products. |
None |
5/31/2018 |
CTP |
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Premium Cigars; Request for Scientific Information |
0910-AH88 |
ANPRM |
The notice would request information on how premium cigars should be defined, the health effects of these products, and their patterns of use. In the proposed deeming rule, FDA had requested scientific information that would support consideration of exempting premium cigars from regulation. FDA received comments claiming that the health risks associated with cigar use generally, or with the use of premium cigars in particular, are not significant because of the way these products are used. Specifically, commenters claimed that these products are not used by youth and young adults, they are not used frequently, and they are not always inhaled. However, the information in the comments did not provide an adequate scientific basis or public health rationale to support excluding these products from regulation. |
None |
6/30/2018 |
CTP |
|
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Food Standards: General Principles and Food Standards Modernization (Reopening of Comment Period) |
0910-AC54 |
Proposed Rule |
FDA is re-opening the comment period on a proposed rule, issued jointly with USDA/FSIS in 2005, that proposed to establish general principles that would be the first step in modernizing and updating the framework for food standards (also known as standards of identity). We are re-opening the comment period because of the time that has elapsed since the publication of the proposed rule during which time there have been additional technological advances and other changes in the food industry which could help inform the development of a modernized food standards framework. |
None |
12/31/2018 |
CFSAN |
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Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products |
0910-AF31 |
Proposed Rule |
FDA will be proposing a rule to add the common cold indication to certain over-the-counter (OTC) antihistamine active ingredients. This proposed rule is the result of collaboration under the U.S.-Canada Regulatory Cooperation Council (RCC) as part of efforts to reduce unnecessary duplication and differences. This pilot exercise will help determine the feasibility of developing an ongoing mechanism for alignment in review and adoption of OTC drug monograph elements. |
None |
11/30/2018 |
CDER |
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|
Sunscreen Drug Products For Over-The-Counter-Human Use; Tentative Final Monograph |
0910-AF43 | Proposed Rule | The proposed rule will address the general recognition of safety and effectiveness (GRASE) status of the 16 sunscreen monograph ingredients and describe data gaps that FDA believes need to be filled in order for FDA to permit the continued marketing of these ingredients without submitting new drug applications for premarket review. Consistent with the Sunscreen Innovation Act, we also expect to address sunscreen dosage forms and maximum SPF values. |
Final - Statutory Sunscreen Innovation Act |
12/31/2018 |
CDER |
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| Pediatric Study Plan Requirements for New Drug and Biologics License Applications |
Proposed Rule |
FDA is proposing requirements for the content of initial pediatric study plans required to be submitted under the Pediatric Research Equity Act (PREA) which requires sponsors of certain applications to submit a plan for studying their drug/biologic in pediatric patients; a primary factor in the increased ability to provide labeling and other drug information for pediatric patients for many more drug and biological products. Developing drugs for pediatric populations presents unique challenges for drug manufacturers. Although the plans are required to be submitted based on the statutory provision, a regulation is required and will provide clarity, specificity, and direction to sponsors, as well as assist FDA in ensuring compliance, and ultimately help to better advance the study of drugs in pediatric populations to support advancing pediatric indications. |
Final - Statutory Pediatric Study Plans section 506 (title V) FDASIA |
4/30/2019 |
CDER |
|
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| Mammography Quality Standards Act; Amendments to Part 900 Regulations | 0910-AH04 |
Proposed Rule |
FDA is proposing to amend its regulations governing mammography. The amendments would update the regulations issued under the Mammography Quality Standards Act of 1992 (MQSA). FDA is taking this action to address changes in mammography technology and mammography processes that have occurred since the regulations were published in 1997 and to address breast density reporting to patient and health care providers. |
None |
8/31/2018 |
CDRH |
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Investigational New Drug Applications Requirements for Conventional Foods, Dietary Supplements, and Cosmetics |
Proposed Rule | Researchers conducting studies of FDA-regulated products involving human subjects must, in some circumstances, meet requirements set out in FDA’s Investigational New Drug (IND) Application regulations. The proposed rule is intended to broaden the regulatory criteria for studies exempt from IND requirements and provide clarity and consistency regarding when studies evaluating drug uses of products that are lawfully marketed as conventional foods, dietary supplements, or cosmetics are subject to IND review. The proposed rule would also streamline some IND application requirements for certain studies that do not qualify for the new exemption. |
None | 4/30/2019 | OC |
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| National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers Abstract: |
0910-AH11 |
Proposed Rule |
The rulemaking will establish standards for State licensing of prescription drug wholesale distributors and third-party logistics providers. The rulemaking will also establish a Federal system for wholesale drug distributor and third-party logistics provider licensing for use in the absence of a State licensure program. |
Final - Statutory The Drug Supply Chain Security Act of 2013 requires FDA to issue licensure regulations no later than two years after the date of enactment |
11/30/2018 |
CDER |
|
| Laboratory Accreditation for Analyses of Foods |
Proposed Rule |
This proposed rule, if finalized, will enable FDA to recognize accreditation bodies that will accredit laboratories performing analyses of food under certain circumstances to ensure appropriate use of equipment, personnel, and procedures to conduct reliable analyses. A program for accredited laboratories will increase the number of qualified laboratories eligible to perform testing of food, which will help FDA improve the safety of the U.S. food supply. |
Statutory - Establish a program for the testing of food by accredited laboratories and a public registry of recognized accreditation bodies and laboratories accredited by recognized accreditation bodies. 01/04/2015 |
09/31/2018 |
OFVM |
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| Premarket Tobacco Product Applications; Recordkeeping Requirements to Support the Legal Marketing of Certain Tobacco Products |
Proposed Rule |
This proposed rule would establish content and format requirements to ensure that premarket tobacco product applications contain sufficient information for FDA to determine whether the marketing of a new tobacco product should be authorized. Additionally, the proposed rule would set forth the basic procedures for premarket tobacco product application review and require applicants receiving marketing authorization to establish records and make postmarket reports to FDA. The proposed rule would also require tobacco product manufacturers to keep records to support legal marketing of certain tobacco products, such as documents showing that a tobacco product does not need to undergo premarket review. |
None | 1/31/2019 |
CTP |
|
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| Biologics License Applications and Master Files | 0910-AH50 |
Proposed Rule |
The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deems any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020. Some of the affected NDAs were approved using drug master files (DMFs). A DMF, or other master file, allows an applicant to incorporate proprietary information from another manufacturer into its application by reference to the master file. BLAs generally may not rely on drug substance, drug substance intermediate, or drug product information contained in master files. The proposed rule would permit the contained use of DMFs for NDAs subject to the BPCI Act transition. |
None | 5/31/2018 | CDER |
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| Medical Device De Novo Classification Process |
Proposed Rule |
De novo classification decreases regulatory burdens because manufacturers can use a less burdensome application pathway under the FD&C Act to market their devices. The proposed rule would establish procedures and criteria for the de novo process and would make it more transparent and predictable for manufacturers. |
None | 7/31/2018 | CDRH |
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Post Approval Changes to Approved Applications |
Proposed Rule |
The proposed rule would update the existing regulations governing supplements and other changes to approved new drug applications (NDAs) abbreviated new drug applications (ANDAs), and biologics license applications (BLAs), as well as regulations regarding certain post-approval reports. |
None |
3/31/2019 |
CDER |
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Certain Requirements Regarding Prescription Drug Marketing (203 Amendment) |
0910-AH56 | Proposed Rule | The Food and Drug Administration (FDA) is amending the regulations at 21 CFR 203 to remove provisions no longer in effect and incorporate conforming changes following enactment of the Drug Supply Chain Security Act (DSCSA). In this proposed rulemaking, the agency is amending the regulations to clarify provisions and avoid causing confusion with the new standards for wholesale distribution established by DSCSA. |
None |
11/30/2018 |
CDER |
|
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Definition of the Term "Biological Product" |
Proposed Rule |
The Food and Drug Administration (FDA) proposes to amend its regulation that defines biological product to conform to the statutory definition (21 U.S.C. 262) adopted in the Biologics Price Competition and Innovation Act of 2009. |
None |
5/31/2018 |
CDER |
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Current Good Manufacturing Practice for Positron Emission Tomography Drugs |
Proposed Rule |
The Food and Drug Administration proposes to amend its current good manufacturing processes regulations for positron emission tomography (PET) drugs to delete a reference to an outdated United States Pharmacopeia (USP) chapter and to streamline these requirements to make them applicable to the production, quality assurance, holding and distribution of all PET drugs This proposed rule removes outdated references, thus bringing the regulations in line with current industry practices. |
None |
12/31/2018 |
CDER |
|
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| Establishment Registration and Product Listing for Tobacco Products | 0910-AH59 | Proposed Rule | The proposed regulation prescribes the format, content, and procedures for establishment registration and tobacco product listings for both domestic and foreign manufacturers of tobacco products. The registration submission would include a manufacturer submitting general information about the manufacturing operation (e.g., the name of the company, location of the facility, contact telephone number) and the product listing submission would include information about the tobacco products it manufacturers. The proposed rule defines who would be required to register and list, when they would be required to register and list, how they would be required to register and list, and describes the type of listing information that manufactures would be required to submit to FDA. The proposed regulations generally would require the electronic submission of all registration and listing information. In addition, the rule would require owners or operators to maintain a historical file of labeling and advertisements. | None | 11/30/2018 | CTP | |
|
Nonprescription Drug Product with an Additional Condition for Nonprescription Use |
0910-AH62 | Proposed Rule |
The proposed rule is intended to increase access to nonprescription drug products. The proposed rule would clarify the requirements for a drug product that could be marketed as a nonprescription drug product with a requirement that ensures consumers’ appropriate self-selection, appropriate actual use, or both in order to obtain the drug without a prescription. |
None | 2/28/2019 | CDER |
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| Medication Guides; Patient Medication Information | 0910-AH68 |
Proposed Rule |
The proposed rule would amend FDA medication guide regulations to require a new form of patient labeling, Patient Medication Information, for submission to and review by the FDA for human prescription drug products and certain blood products used, dispensed, or administered on an outpatient basis. The proposed rule would include requirements for Patient Medication Information development and distribution. The proposed rule would require clear and concisely written prescription drug product information presented in a consistent and easily understood format to help patients use their prescription drug products safely and effectively. |
None |
02/30/2019 |
CDER |
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Updating Public Information Regulations |
0910-AH69 |
Proposed Rule |
FDA is proposing to amend its public information regulations. The proposed amendments bring the agency’s regulations in line with statutory amendments to the FOIA, update cross references to other statutes and parts of the agency’s regulations, and clarify certain provisions with minor editorial updates. Additionally, the rule will update the current regulations to reflect changes to the organization, to make the FOIA process easier for the public to navigate, and to make certain provisions clearer, such as the provisions regarding processing fees. Taken together, these changes will enhance transparency for the public with regard to FDA’s activities. | None | 5/31/2018 | OC |
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| Revision of Product Jurisdiction Regulations |
Proposed Rule |
FDA is proposing to amend its regulation on classifying medical products as drugs, devices, biological products or combination products (products composed of two or more different types of medical products, e.g., a drug and device) and on Center assignment and regulation of combination products, in two respects. First, it would remove a duplicative administrative appeals process for appealing product classification and assignment determinations, streamlining the process for appealing these determinations for product sponsors and FDA staff and making the process more efficient. Second, it would also enhance regulatory clarity and efficiency by removing a provision that might be interpreted inconsistently with new requirements under the 21st Century Cures Act, which address when combination products can be marketed under a single application for the complete combination product or under separate applications for each constituent part (e.g., the drug and device) of the combination product. | None | 5/31/2018 |
OC |
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| The Food and Drug Administration Food Safety Modernization Act; Removing Written Assurance Requirements From the Customer Provisions in Certain Implementing Rules | 0910-AH77 | Proposed Rule | This proposed rule, would remove certain requirements that currently apply when a manufacturer/processor of human food or animal food has identified a hazard that requires a preventive control, but does not control that hazard. Although that manufacturer/processor would still be required to provide documentation that the food has not been processed to control the identified hazard, that manufacturer/processor would no longer be required to obtain written assurance from the customer that the identified hazard will be controlled. This action, also proposes to remove analogous requirements that apply to importers of food for humans and animals. | None | 11/30/2018 | OFVM | |
| Permanent Listing of Color Additive Lakes | 0910-AH80 | Proposed Rule | This proposed rule would streamline and clarify the regulations for color additive lakes (insoluble pigments prepared by chemically reacting water-soluble dyes with water-insoluble substances). This proposed rule would consolidate current regulatory provisions and would permanently list certain color additive lakes as suitable and safe for use in foods, drugs, and cosmetics. The proposed rule also would prescribe conditions for the preparation of these lakes. | None | 12/30/2018 | CFSAN | |
| Amendments to the Final Rule Regarding the List of Bulk Drug Substances That Can Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act | 0910-AH81 | Proposed Rule | This proposed rule proposes to add additional bulk drug substances to the list of bulk drug substances that may be used to compound drug products that qualify for the exemptions in section 503A of the FD&C Act (the List). Currently, the only bulk drug substances that may be used to compound drugs that qualify for the section 503A exemptions are those that are the subject of an applicable United States Pharmacopeia or National Formulary monograph, a component of an FDA-approved drug, or those that FDA has already placed on the List. This proposed rule will identify approximately 30 additional bulk drug substances nominated by stakeholders for the List and explain whether FDA proposes the substance be included on the List. | None | 11/30/2018 | CDER | |
| Amendments to Registration of Food Facilities | 0910-AH82 | Proposed Rule | The proposed rule would make clarifying changes to general provisions related to the registration of food facilities rule, including edits to the definition of farm. | None | 4/30/2019 | OFVM | |
| Food Labeling: Calorie Labeling of Articles of Food Sold From Certain Vending Machines; Front of Package Type Size | 0910-AH83 | Proposed Rule | FDA is proposing to amend its regulations on the type size requirement for calorie declarations for certain foods sold from chain vending machines covered by statutory calorie disclosure requirements. If finalized, the proposed rule would change the type size requirements for Front of Pack (FOP) labeling in glass front vending machines. | None | 5/31/2018 | CFSAN | |
| Format and Content of Reports Intended to Demonstrate Substantial Equivalence | 0910-AH89 | Proposed Rule | This proposed rule would establish the format and content of reports intended to demonstrate substantial equivalence (SE) in tobacco products and would provide information as to how the agency will review and act on these submissions. | None | 8/31/2018 | CTP | |
| Testing Standards for Batteries and Battery Management Systems in Electronic Nicotine Delivery Systems | 0910-AH90 | Proposed Rule |
This rule would propose to establish a product standard to require testing standards for batteries used in electronic nicotine delivery systems (ENDS) and require design protections through a battery management system for ENDS using batteries. This product standard would protect the safety of users of battery-powered tobacco products and will help to streamline the FDA premarket review process, ultimately reducing the burden on both manufacturers and the agency. The proposed rule would be applicable to tobacco products that include a non-user replaceable battery as well as products that include a user replaceable battery. |
None | 12/31/2018 | CTP | |
| Requirements for Tobacco Product Manufacturing Practice | 0910-AH91 | Proposed Rule | The rule is proposing to establish tobacco product manufacturing practice (TPMP) requirements for manufacturers of finished and bulk tobacco products. This proposed rule, if finalized, would set forth requirements for the manufacture, pre-production design validation, packing, and storage of a tobacco product. This proposal would help prevent the manufacture and distribution of contaminated and otherwise nonconforming tobacco products This proposed rule provides manufacturers with flexibility in the manner in which they comply with the proposed requirements while giving FDA the ability to enforce regulatory requirements, thus helping to assure the protection of public health. | None | 11/30/2018 | CTP | |
| Updated Regulations for Medical Gases | 0910-AH96 | Proposed Rule | FDA intends to propose revisions to certain regulations with regard to medical gases. These proposed changes are anticipated to include, but are not necessarily limited to, specific changes to current good manufacturing practice (cGMP), labeling, and postmarket reporting regulations applicable to medical gases, generally aiming for less stringent regulation where appropriate. | Final - Statutory Statute enacted in May 2017 with July 2017 final rule deadline 7/15/2017 |
4/30/2019 | CTP | |
| Harmonizing and Modernizing Regulation of Medical Device Quality Systems | 0910-AH99 | Proposed Rule |
FDA intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will supplant the existing requirements with the specifications of an international consensus standard for medical device manufacture, ISO 13485:2016. The revisions are intended to reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements. The revisions will also modernize the regulation. |
None | 4/30/2019 | CDRH | |
| Food Additives: Food Contact Substance Notification That Is No Longer Effective | 0910-AI01 | Proposed Rule | FDA is proposing to amend its food additive regulations to allow a Food Contact Substance Notification (FCN) to become no longer effective for reasons other than safety. In addition, under the proposed rule, FDA would provide manufacturers or suppliers an opportunity to address any safety concerns earlier in the determination process. | None | 12/31/2018 | CFSAN | |
| Proposed Rule to Revise the Allowable Level of Fluoride Added to Bottled Water | 0910-AI03 | Proposed Rule | The proposed rule would revise the quality standard regulations for fluoride in fluoridated bottled water to make them consistent with a 2015 recommendation by the United States Public Health Service (PHS) for optimal fluoride concentration in community water systems. This action, if finalized, will not affect the allowable levels of fluoride in non-fluoridated bottled water (i.e., bottled water to which fluoride is not added, but which may contain fluoride from its source water). | None | 06/31/2018 | CFSAN | |
| Administration Detention of Tobacco Products | 0910-AI05 | Proposed Rule | The Food and Drug Administration is proposing regulations to establish requirements for the administrative detention of tobacco products. This action, if finalized, would allow FDA to administratively detain tobacco products encountered during inspections that an officer or employee conducting the inspection has reason to believe are adulterated or misbranded. The intent of administrative detention is to protect public health by preventing the distribution or use of volatile tobacco products until FDA has had time to consider the appropriate action to take and, where appropriate, to initiate a regulatory action. | None | 11/30/2018 | CTP | |
| Safety Standards for Toxicants and Impurities in Nicotine, Propylene Glycol, and Vegetable Glycerin Used in E-Liquids; Tobacco Product Standard | 0910-AI06 | Proposed Rule | The Food and Drug Administration is proposing regulations to establish tobacco product standards for nicotine, propylene glycol, and vegetable glycerin purity in e-liquid. This rule, if finalized, would establish limits on the level of toxicants and impurities found in nicotine, propylene glycol, and vegetable glycerin. Toxicants and impurities found in nicotine, propylene glycol, and vegetable glycerin can cause death or other adverse health effects, and this rule would establish limits on the level of those toxicants that are appropriate for the protection of public health. | None | 3/31/2019 | CTP | |
| Institutional Review Boards; Cooperative Research | 0910-AI08 | Proposed Rule | This proposed rule would replace current FDA requirements for cooperative research such that any institution located in the United States (U.S.) participating in multisite cooperative research would need to rely on approval by a single Institutional Review Board (IRB) for that portion of the research that is conducted in the U.S., with some exceptions. This proposed rule would also establish an IRB recordkeeping requirement for research that takes place at an institution in which IRB oversight is conducted by an IRB that is not operated by the institution. | Statutory - Final 12/13/2019 | 12/31/2018 | OGCP | |
| Responsibilities for the Initiation and Conduct of Clinical Investigations | 0910-AI09 | Proposed Rule | The proposed rule updates FDA’s investigational new drug application (IND) regulations to define and clarify the roles and responsibilities of the various persons engaged in the initiation, conduct, and oversight of clinical investigations subject to IND requirements. The proposed changes would better protect the rights, safety, and welfare of subjects and help ensure the integrity of clinical trial data. The proposed rule should help reduce study misconduct and ensure the integrity of clinical trial data (benefits) while requiring additional documenting, reporting, and recordkeeping for clinical investigators (costs). | None | 4/30/2019 | CDER | |
| Postmarketing Safety Reporting Requirements for Human Drug and Biological Products | 0910-AA97 | Final Rule | The final rule would amend the postmarketing safety reporting regulations for human drugs and biological products including blood and blood products in order to better align FDA requirements with guidelines of the International Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH); and to update reporting requirements in light of current pharmacovigilance practice and safety information sources and enhance the quality of safety reports received by FDA. These revisions were proposed as part of a single rulemaking (68 FR 12406) to clarify and revise both premarketing and postmarketing safety reporting requirements for human drug and biological products. Premarketing safety reporting requirements were finalized in a separate final rule published on September 29, 2010 (75 FR 59961). This final rule applies to postmarketing safety reporting requirements. | None | 12/31/2018 | CDER | |
| Reporting Information Regarding Falsification of Data | 0910-AC59 | NPRM - Withdrawal | The final rule would require sponsors of certain clinical and nonclinical studies (and certain other entities) to promptly report to FDA information indicating that any person has or may have engaged in the falsification of data in the course of proposing, designing, performing, recording, supervising, or reviewing research, or in the course of reporting research results. | None | 8/31/2018 | OC | |
| Label Requirement for Food That Has Been Refused Admission Into the United States | 0910-AF61 | NPRM - Withdrawal | The final rule will require owners or consignees to label imported food that is refused entry into the United States. The label will read, "UNITED STATES: REFUSED ENTRY." The proposal describes the label's characteristics (such as its size) and processes for verifying that the label has been affixed properly. We are taking this action to prevent the introduction of unsafe food into the United States, to facilitate the examination of imported food, and to implement section 308 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107-188). | None | 8/31/2018 | OFVM | |
| Import Tolerances for Residues of Unapproved New Animal Drugs in Food | 0910-AF78 | Final Rule | This rule would institute procedures by which a person may request FDA establish or amend tolerances for unapproved new animal drugs where edible portions of animals imported into the United States may contain residues of such drugs (import tolerances), or to revoke an existing import tolerance. Such import tolerances provide a basis for legally marketing food of animal origin that is imported into the United States and contains residues of unapproved new animal drugs. | None | 12/31/2018 | CVM | |
| Laser Products; Amendment to Performance Standard | 0910-AF87 | NPRM - Withdrawal | FDA is proposing to amend the 2013 proposed rule for the performance standard for laser products, which will amend the performance standard for laser products to achieve closer harmonization between the current standard and the recently amended International Electrotechnical Commission (IEC) standard for laser products and medical laser products. The amendment is intended to update FDA's performance standard to reflect advancements in technology. | None | 8/31/2018 | CDRH | |
| Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph | 0910-AF89 | Final Rule | The final rule amends FDA regulations on fixed-combination prescription and over-the-counter (OTC) drugs. Current regulations require, among other things, that the sponsor of a fixed-combination drug demonstrate that each of the components makes a contribution to the drug's claimed effects. The final rule harmonizes the combination drug requirements into a single set of regulations for both prescription and OTC combination drugs, and codifies existing policy on what kinds of studies are needed to show that the combination drug requirements are met. The final rule also applies these regulations to combinations of biological drug products and to drug-biological product combinations; clarifies application of FDA's requirements regarding fixed-dose combinations to certain natural source drugs and certain synthetic drugs; establishes circumstances under which the agency might waive the combination requirements for a particular drug or biological product; and addresses the issue of co-packaging. | None | 2/28/2019 | CDER |
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| New Animal Drugs: Updating Tolerances for Residues of New Animal Drugs in Food | 0910-AG17 | Final Rule | This rule would revise the animal drug regulations regarding tolerances for residues of approved and conditionally approved applications for conditional approval of new animal drugs in food by standardizing, simplifying, and clarifying the determination standards and codification style. In addition, this rule would add definitions for key terms. The purpose of the revision is to enhance understanding of tolerance determination and improve the readability of the regulations. | None | 12/31/2018 | CVM | |
| Electronic Submission of Labeling for Certain Home-Use Devices | 0910-AG79 | NPRM - Withdrawal |
This rule would require medical device establishments listing certain home-use medical devices to submit, in electronic format, the label and package insert of such medical devices listed with FDA. FDA intends to make the information from the submitted labeling accessible by the public through a focused Internet site.
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None | 8/31/2018 | CDRH | |
| Food Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or Distilled Foods | 0910-AH00 | Final Rule | This final rule would establish requirements concerning ‘‘gluten-free’’ labeling for foods that are fermented or hydrolyzed or that contain fermented or hydrolyzed ingredients. These additional requirements for the ‘‘gluten-free’’ labeling rule are needed to help ensure that individuals with celiac disease are not misled and receive truthful and accurate information with respect to fermented or hydrolyzed foods labeled as ‘‘gluten-free.’’ | NPRM Statutory 08/04/2006 Final Statutory 08/04/2008 |
12/31/2018 | CFSAN | |
| List of Bulk Drug Substances That Can Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act | 0910-AH29 | Final Rule |
This rule will establish the statutorily required list of additional bulk drug substances that may be used to compound drug products that qualify for the exemptions in section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (the section 503A exemptions). Currently, the only bulk drug substances that may be used to compound drug products that qualify for the section 503A exemptions are those that are the subject of an applicable United States Pharmacopeia or National Formulary monograph, or a component of an FDA-approved drug. This final rule will also identify the criteria for evaluating additional bulk drug substances that may be used to compound drug products that qualify for the section 503A exemptions and list substances that were considered and are not included. The rule will provide clarity to stakeholders about what bulk drug substances can be used to compound drug products that qualify for the section 503A exemptions by identifying additional bulk drug substances.
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None | 8/31/2018 | CDER | |
| Repeal of Regulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation | 0910-AH47 | Direct Final Rule | This would repeal a requirement that any drug sterilized by irradiation is considered a new drug” and subject to the approval requirements of a new drug and not to be produced under an OTC monograph. This would mean that FDA pre-approval would no longer be required for over-the-counter drugs sterilized by irradiation that otherwise could be marketed legally without an approved new drug application or abbreviated new drug application. FDA is taking this action because the irradiation regulation is out of date and unnecessary. The technology of controlled nuclear radiation is better understood. Other FDA regulations require drugs marketed pursuant to an OTC drug monograph be manufactured in compliance with current good manufacturing practices (CGMPs). Appropriate and effective sterilization, including irradiation, is adequately addressed by the CGMP requirements. | None | 5/31/2018 | CDER | |
| Amending Premarket Regulations That Require Multiple Copies and Specify Paper Copies to be Allowed in Electronic Format | 0910-AH48 | Direct Final Rule | The Food and Drug Administration (FDA or agency) is amending its regulations to remove requirements to submit multiple paper copies of medical device regulatory pre-submissions and submissions and replace them with one copy in an electronic format. We are revising premarket submissions and registration and listing regulations to make an efficient and effective electronic submission program. | None | 5/31/2018 | CDRH | |
| Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements | 0910-AH51 | Final Rule | FDA is amending its postmarketing safety reporting regulations for approved new animal drugs to remove requirements that certain adverse drug experience and product/manufacturing defect reports be submitted to us in a paper format and replace it with an electronic format. |
None | 2/28/2019 | CVM | |
| Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations | 0910-AH52 | Direct Final Rule | This regulation will permit an Institutional Review Board (IRB) to waive informed consent under certain conditions for minimal risk clinical investigations. This will facilitate certain minimal risk clinical investigations to support the development of new products to diagnose or treat disease and will harmonize with the HHS Common Rule waiver provision that has been adopted and successfully employed by other agencies. This regulation is intended to aid patient access to new products by facilitating investigators’ ability to conduct studies that may contribute substantially to the development of products to diagnose or treat conditions, or address unmet medical needs. | None | 5/31/2018 | OGCP | |
| Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software | 0910-AH54 | Final Rule | The Food and Drug Administration is issuing a final rule to classify the blood establishment computer software (BECS) and BECS accessories into class II (special controls) and subject to premarket review. FDA has identified special controls for BECS and BECS accessories that are necessary to provide a reasonable assurance of safety and effectiveness. | None | 6/30/2018 | CBER | |
| Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-ray, Laser and Ultrasonic Products | 0910-AH65 | Direct Final Rule | The rule will update FDA radiological health regulations and withdraw parts of the general provisions, records and reports requirements, and electronic performance standards for radiological devices. Current regulations contain radiation protection recommendations, reporting requirements for manufacturers and assemblers of electronic products, and performance standards for certain electronic products. Some of the current regulations apply to electronic products (i.e., not necessarily having a medical application) but not devices (i.e., having a medical application). The regulation would eliminate radiation protection recommendations, reporting requirements for certain electronic products, and performance standards that have been identified as obsolete and no longer necessary. | None | 9/30/2018 | CDRH | |
| Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Veterinary Devices | 0910-AH66 | Direct Final Rule | The FDA is issuing a direct final rule and a companion proposed rule to require that certain data elements be submitted to Customs and Border Protection and FDA for veterinary devices to ensure that FDA has adequate information to determine admissibility. This rule ensures that the regulations on import submissions for veterinary devices are the same as for all other FDA regulated products. | None | 10/31/2018 | CVM | |
| Amendments and Repeal to Medical Device Software Regulations | 0910-AH67 | Direct Final Rule | The 21st Century Cures Act amended the definition of device under the Federal Food, Drug, and Cosmetic Act to exclude certain medical software functions from the definition of device and therefore FDA’s jurisdiction. FDA will revise its regulations to be consistent with this statutory change. | None | 10/31/2018 | CDRH | |
| Medical Devices; Medical Device Classification Procedures | 0910-AH75 | Final Rule | The Final Rule implements Section 608 of the Food and Drug Administration Safety and Innovation Act (FDASIA) requiring FDA to use administrative orders to announce or to change the classification of devices, instead of taking action by regulation. | None | 11/30/2018 | CDRH | |
| Food Labeling: Revision of the Nutrition and Supplement Facts Labels and Serving Sizes of Foods | 0910-AH92 | Final Rule | The Food and Drug Administration (FDA or we) is extending the compliance date for the final rules providing updated nutrition information on the label of food and dietary supplements; defining a single-serving container; requiring dual-column labeling for certain containers; updating, modifying, and establishing several reference amounts customarily consumed (RACCs); and amending the label serving size for breath mints. | None | 5/31/2018 | CFSAN | |
| Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, Extension of Compliance Dates for Subpart E | 0910-AH93 | Final Rule | The Food and Drug Administration is extending, for covered produce other than sprouts, the dates for compliance with the agricultural water provisions in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule. We are extending the compliance dates to address questions about the practical implementation of compliance with certain provisions and to consider how we might further reduce the regulatory burden or increase flexibility while continuing to achieve our regulatory objectives, in keeping with the Administration's policies. | None | 6/30/2018 | OFVM | |
| Revocation of the Test for Mycoplasma | 0910-AH95 | Direct Final Rule | This rulemaking would revoke the required test for Mycoplasma related to vaccine products because current testing methods are outdated and more sensitive and specific methods exist and are currently being practiced. Removal of the Mycoplasma test would provide manufacturers of viral vaccines flexibility for accommodating new and evolving technology and capabilities without diminishing public health protections. | None | 12/31/2018 | CBER | |
| Topical Antimicrobial Drug Products for Over-the-Counter Human Use: Final Monograph for Consumer Antiseptic Rub Products | 0910-AH97 | Final Rule | This final rule amends the 1994 tentative final monograph (TFM) for over-the-counter (OTC) antiseptic drug products that published in the Federal Register of June 17, 1994,(the 1994 TFM). The final rule is part of the ongoing review of OTC drug products conducted by FDA. In this final rule, we address whether certain active ingredients used in OTC consumer antiseptic products intended for use without water (referred to as consumer antiseptic rubs) are not generally recognized as safe and effective (GRAS/GRAE) and are misbranded. | Final Judicial NRDC V FDA, Consent Decree 04/15/2019 | 4/30/2019 | CDER | |
| Microbiology Devices; Classification of In Vitro Diagnostic Devices for Bacillus Species Detection | 0910-AH98 | Final Rule | The final rule will classify in vitro diagnostic devices for Bacillus species (spp.) detection into class II (special controls) FDA is establishing special controls in a special controls guideline that the agency believes are necessary to provide a reasonable assurance of the safety and effectiveness of the devices. Bacillus spp. is used to detect and differentiate among Bacillus spp. and presumptively identify Bacillus anthracis (B. anthracis) and other Bacillus spp. from cultured isolates or clinical specimens, as an aid in the diagnosis of anthrax and other diseases caused by Bacillus spp. | None | 3/31/2019 | CDRH | |
| Classification of Posterior Cervical Screw System | 0910-AI00 | Final Rule | This final rule will classify an unclassified preamendments device into class II with special controls. A posterior cervical screw system is a device used to provide immobilization and stabilization in the cervical spine as an adjunct to spinal fusion surgery. | None | 3/31/2019 | CDRH | |
| Amendment to Add a New Method for the Analysis of Sulfites in Foods | 0910-AI02 | Direct Final Rule | This rule adds a second methodology that will improve the speed and efficiency in FDA testing for sulfites in food for enforcement activities. | None | 3/31/2019 | CFSAN | |
| Crabmeat; Amendment of Common or Usual Name | 0910-AI04 | Direct Final Rule | This rule replaces brown king crabmeat with golden king crabmeat as the sole common or usual name of crabmeat derived from the species Lithodes aequispinus, and revises the scientific name to read as Lithodes aequispinus. We are issuing this rule in response to section 774 of the 2017 Consolidated Appropriations Act stating that, for purposes of applying the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), the acceptable market name of Lithodes aequispinus is golden king crab. This rule also includes a technical amendment to clarify that Paralithodes platypus is a scientific name, not a common or usual name. | None | 11/30/2018 | CFSAN | |
| Part 50 Protection of Human Subjects and Part 56 Institutional Review Boards | 0910-AI07 | Direct Final Rule | This direct final rule will amend several sections of FDA’s regulations for the Protection of Human Subjects and Institutional Review Boards to harmonize with the recently revised final HHS Common Rule (42 CFR 46, subpart A). This rule adds definitions, conforms wording, and makes minor editorial changes to FDA regulations to harmonize with the Common Rule. The rule also makes minor technical amendments unrelated to the harmonization efforts. | Part 50 Protection of Human Subjects and Part 56 Institutional Review Boards | 12/31/2018 | OC | |
| Combinations of Bronchodilators With Nasal Decongestant; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use | 0910-AF33 | Final Rule | The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective, and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. These actions address cough/cold drug products containing an oral bronchodilator (ephedrine and its salts) in combination with any oral nasal decongestant. | None | Long Term Action | CDER | |
| Over-the-Counter (OTC) Drug Review--External Analgesic Products | 0910-AF35 | Proposed Rule | The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The final action addresses the 2003 proposed rule on patches, plasters, and poultices. The proposed rule will address issues not addressed in previous rulemakings. | None | Long Term Action | CDER | |
| Over-the-Counter (OTC) Drug Review--Internal Analgesic Product | 0910-AF36 | Proposed Rule | The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective, and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first action addresses acetaminophen safety. The second action addresses products marketed for children under 2 years old and weight- and age-based dosing for children's products. | None | Long Term Action | CDER | |
| Over-the-Counter (OTC) Drug Review--Laxative Drug Product | 0910-AF38 | Final Rule | The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective, and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The final rule listed will address the professional labeling for sodium phosphate drug products. | None | Long Term Action | CDER | |
| Over-the-Counter (OTC) Drug Review--Oral Health Care Products | 0910-AF40 | Final Rule | The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective, and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The rule will address the safety of oral health care products and the category of ingredients used for oral health care. | None | Long Term Action | CDER | |
| Over-the-Counter (OTC) Drug Review--Weight Control Products | 0910-AF45 | Final Rule | The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The final action finalizes the 2005 proposed rule for weight control products containing phenylpropanolamine. | None | Long Term Action | CDER | |
| Over-the-Counter (OTC) Drug Review--Pediatric Dosing for Cough/Cold Products | 0910-AG12 | Proposed Rule | The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective, and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action will propose changes to the final monograph to address safety and efficacy issues associated with pediatric cough and cold products. | None | Long Term Action | CDER | |
| Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products | 0910-AG18 | Final Rule | This rule would require electronic package inserts for human drug and biological prescription products with limited exceptions, in lieu of paper, which is currently used. These inserts contain prescribing information intended for healthcare practitioners. This would ensure that the information accompanying the product is the most up-to-date information regarding important safety and efficacy issues about these products. | None | Long Term Action | CDER | |
| Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, Neutral Manner | 0910-AG27 | Final Rule | The Food and Drug Administration (FDA) is amending its regulations concerning direct-to-consumer (DTC) advertisements of prescription drugs. Prescription drug advertisements broadcast through media such as TV and radio directly to consumers must disclose the product’s major risks in what is sometimes called the major statement. The rule would require that the major statement in DTC television and radio advertisements relating to the side effects and contraindications of an advertised prescription drug be presented in a clear, conspicuous, and neutral manner. FDA is also implementing standards that would be considered in determining whether the major statement in these advertisements is presented in the manner required. | None | Long Term Action | CDER | |
| Sunlamp Products; Amendment to the Performance Standard | 0910-AG30 | Final Rule | FDA is updating the performance standard for sunlamp products to improve safety, reflect new scientific information, and work towards harmonization with international standards. By harmonizing with the International Electrotechnical Commission, this rule will decrease the regulatory burden on industry and allow the agency to take advantage of the expertise of the international committees thereby also saving resources. | None | Long Term Action 12/31/2019 |
CDRH | |
| Investigational Tobacco Product Applications | 0910-AH06 | Proposed Rule | The proposed rule would define investigational tobacco product (ITP) and describe the procedures and requirements relating to the use of investigational tobacco products in investigations. The proposed rule would establish the information an ITP application to FDA must include, such as study protocol and adverse events. FDA will use this information to review the investigation for important concerns, such as the protection of human subjects. The proposed rule will provide detail on what happens when an investigation does not meet regulatory requirements. Finally, the proposed rule will also state responsibilities of those involved with administering the investigation and recordkeeping requirements. | None | Long Term Action 1/31/2020 |
CTP | |
| General and Plastic Surgery Devices: Sunlamp Products | 0910-AH14 | Final Rule | This rule would apply device restrictions to sunlamp products. Sunlamp products include ultraviolet (UV) lamps and UV tanning beds and booths. The incidence of skin cancer, including melanoma, has been increasing, and a large number of skin cancer cases are attributable to the use of sunlamp products. The devices may cause about 400,000 cases of skin cancer per year, and 6,000 of which are melanoma. Beginning use of sunlamp products at young ages, as well as frequently using sunlamp products, both increases the risk of developing skin cancers and other illnesses, and sustaining other injuries. Even infrequent use, particularly at younger ages, can significantly increase these risks. This rule would apply device restrictions to sunlamp products. | None | Long Term Action 12/31/2019 |
CDRH | |
| Combinations of Bronchodilators With Expectorants; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use | 0910-AH16 | Final Rule | The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective, and not misbranded. After a final monograph (i.e. final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. These actions address cough/cold drug products containing an oral bronchodilator (ephedrine and its salts) in combination with any expectorant. | Final - Statutory 12/01/2014 |
Long Term Action | CDER | |
| Nicotine Exposure Warning and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquids, and Other Tobacco Products | 0910-AH24 | Proposed Rule | This rule would establish nicotine exposure warning and child-resistant packaging requirements for liquid nicotine and nicotine-containing e-liquid(s) that are made or derived from tobacco and intended for human consumption, and potentially for other tobacco products including, but not limited to, novel tobacco products such as dissolvables, lotions, gels, and drinks. This action is intended to protect users and non-users from accidental exposures to nicotine-containing e-liquids in tobacco products. | None | Long Term Action 3/31/2020 |
CTP | |
| Amendments to the Regulation Regarding the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness | 0910-AH35 | Final Rule | This rule would amend the regulation regarding the list of drug products that may not be compounded under sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act, because the drug products have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective. | None | Long Term Action 05/31/2019 |
CDER | |
| Internal Agency Review of Decisions; Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and Radiological Health | 0910-AH37 | Final Rule | FDA is updating the regulations governing internal agency supervisory review of certain decisions related to devices regulated by the Center for Devices and Radiological Health (CDRH) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to conform to the applicable provisions in the Food and Drug Administration Safety and Innovation Act (FDASIA). FDA is taking this action to put into place the procedures and timeframes that apply to supervisory review of significant decisions pertaining to devices. This regulation will also provide procedures and a timeframe for requesting internal agency supervisory review of other types of decisions made by CDRH not addressed in the FDASIA requirements. These actions will improve FDA’s accountability and regulatory certainty with respect to CDRH’s significant decisions with respect to devices. | None | Long Term Action 05/31/2019 |
CDRH | |
| Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease | 0910-AH43 | Final Rule | This final rule would amend FDA's regulation authorizing the use of health claims regarding the relationship between soy protein and coronary heart disease on the label or in the labeling of foods. | None | Long Term Action 09/30/2019 |
CFSAN | |
| Current Good Manufacturing Practice for Outsourcing Facilities | 0910-AH61 | Proposed Rule | This rule would set forth the minimum current good manufacturing practice (cGMP) requirements for human drug products compounded by an outsourcing facility. | None | Long Term Action 10/31/2019 |
CDER | |
| Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices | 0910-AG48 | Final Rule | This rule updates FDA’s requirements for accepting clinical data used to bring new medical devices to market as part of fulfilling FDA’s mission. While helping to ensure the quality and integrity of clinical trial data and the protection of study participants, this rule should reduce burden on industry by avoiding the need for on-site inspections. This rule parallels the drug regulation, which should further reduce burden by having a harmonized approach. Under this new rule, a device applicant would provide FDA with information about the conduct of their study such as, the research sites where the study was conducted, the investigators who conducted the study, a summary of the protocol, information about how informed consent from the study participants was obtained, and information about the ethics committee that reviewed the study. (If such information is not available, the sponsor may explain why and request a waiver.) | None | Completed Action 2/21/2018 |
OC | 83 FR 7366 |
| Safety and Effectiveness of Healthcare Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | 0910-AH40 | Final Rule | This rulemaking addresses whether FDA considers certain active ingredients in over-the-counter (OTC) healthcare antiseptic hand wash and healthcare antiseptic products to be generally recognized as safe and effective. If FDA determines that the ingredient is not generally recognized as safe and effective, a manufacturer will not be able to market the product unless it submits and receives approval of a new drug application. | Final - Judicial 01/15/2018 |
Completed Action 12/20/2017 |
CDER | 82 FR 60474 |
| Removal of Time of Inspection and Duties of Inspector Regulations for Biological Products | 0910-AH49 | Direct Final Rule | The Food and Drug Administration is amending the general biologics regulations by removing mandatory inspection requirements for biologics. FDA is taking this action to remove outdated requirements and allow inspection frequency based on risk. This action is part of FDA’s retrospective review of its regulations and will better target agency resources. | None | Completed Action 1/26/2018 |
CBER | 83 FR 3586 |
| New Animal Drugs for Investigational Use; Disqualification of a Clinical Investigator | 0910-AH64 | Final Rule |
The FDA is amending its regulations for new animal drugs for investigational use to expand the scope of clinical investigator disqualification to include ineligibility to conduct nonclinical laboratory studies. Under this final rule, when the FDA Commissioner determines that an investigator is ineligible to receive a new animal drug for investigational use, the investigator will be ineligible to conduct both clinical and nonclinical studies intended to support an application for a research or marketing permit for a new animal drug. This final rule will help ensure adequate protection of animal research subjects and the quality and integrity of data submitted to FDA. |
None | Completed Action 12/28/2017 |
CVM | 82 FR 61443 |
| Record Keeping Requirements Related to Tobacco Product Applications | 0910-AH74 | Withdrawn | The Food and Drug Administration is proposing regulations to establish recordkeeping requirements for persons who submit certain tobacco product submissions to FDA, such as premarket tobacco product applications, modified risk tobacco product applications, requests for exemption from substantial equivalence, and abbreviated reports. The manufacturer would be required to maintain all records necessary to support the application or submission. This regulation would also establish recordkeeping requirements for persons who commercially market tobacco products that were commercially marketed (other than exclusively in test markets) in the United States as of February 15, 2007. | None | Completed Action | CTP | |
| Suspension of Registration of Food Facilities | 0910-AH79 | Withdrawn | This proposed rule is part of our implementation of our authority to suspend the registration of food facilities, as provided in the FDA Food Safety Modernization Act (FSMA). Specifically, FSMA authorizes FDA to suspend the registration of a registered facility if the food manufactured, processed, packed, received, or held by that facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, if the facility created, caused, or was otherwise responsible for such a reasonable probability; or knew of, or had reason to know of, such reasonable probability and packed, received or held such food. This proposed rule also provides information related to the informal hearing process and the process for reinstating a suspended facility’s registration. | None | Completed Action | OFVM | |
| Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments Regarding "Intended Uses" "Delay of Effective Date" | 0910-AH94 | Final Rule | FDA is delaying the effective date of amendments to the existing medical product ‘‘intended uses’ regulations, contained in the final rule of January 9, 2017, until further notice. | None | Completed Action 3/16/2018 |
CTP | 83 FR 11639 |