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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. As part of FDA’s Transparency Initiative and FDA Transparency Results Accountability Credibility Knowledge Sharing (TRACK), we are also providing periodic updates on FDA’s upcoming rulemakings. 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.

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Formal TitleRINStageAbstractLegal DeadlineProjected Publication DateFDA Lead OrganizationNotes

Submission of Food and Drug Administration Import Data in the Automated Commercial Environment

0910-AH41

Final Rule

The Food and Drug Administration (FDA, the Agency, or we) will establish requirements for the electronic filing of entries of FDA-regulated products in the Automated Commericial Environment (ACE) or any other electronic data interchange (EDI) system authorized by the U.S. Customs and Border Protection (CBP), in order for the filling to be processed by the CBP and to help FDA in determining admissibility of the product.

None

11/29/2016

ORA

Published

Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain RACCs 

0910-AF23

Final Rule

FDA is amending its labeling regulations for foods to provide update, modify, and establish Reference Amounts Customarily Consumed (RACCs) for certain food categories. This rule would provide consumers with nutrition information based on the amount of food that is customarily consumed, which would assist consumers in maintaining healthy dietary practices. In addition to updating, modifying, and establishing certain RACCs, FDA is amending the definition of a single-serving containers; amending the label serving size for breath mints; and providing for dual-column labeling under certain circumstances, which would provide nutrition information per serving and per container or unit, as applicable; and making technical amendments to various aspects of the serving size regulations.

None

5/27/2016

CFSAN

 Published

Electronic Submission of Labeling for Certain Home-Use Devices

0910-AG79

Proposed Rule

The purpose of the proposed rule is to 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.

None

NPRM Published 10/17/2016


NPRM Comment Period End 1/17/2017

CDRH

 

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

1/31/2017

CDER

 

Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use

0910-AF69

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. This action addresses antimicrobial agents in consumer antiseptic hand wash.

None

9/6/2016

CDER

 Published

Topical Antimicrobial Drug Products for Over-the-Counter Human Use: Final Monograph for Consumer Antiseptic Wash Products 

0910-AH40

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 with water (referred to as consumer antiseptic washes) are not generally recognized as safe and effective (GRAS/GRAE) and are misbranded.

None

Long Term Action

CDER

 

Laser Products; Amendments to Performance Standard

0910-AF87

Proposed Rule

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

Long Term Action

CDRH

 

Amendments to Regulations on Citizen Petitions, Petitions for Stay of Action, and Submission of Documents to Dockets; Implementation of Section 505(q) of the Federal Food, Drug, and Cosmetic Act

0910-AG26

Final Rule

The Food and Drug Administration (FDA) is proposing to amend certain regulations relating to citizen petitions, petitions for stay of action, and the submission of documents to the Agency. We are making these changes to implement certain provisions of section 914 of title IX of the Food and Drug Administration Amendments Act, which added section 505(q) to the Federal Food, Drug, and Cosmetic Act.

None

11/30/2016

CDER

 Published

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

0910-AG35

Final Rule

This rule will establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables that are raw agricultural commodities for which the Secretary has determined that such standards minimize the risk of serious adverse health consequences or death. The purpose of the rule is to reduce the risk of illness associated with fresh produce.

Judicial Final 10/31/2015

11/27/2015

OC

 Published

 "Tobacco Products" Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act

0910-AG38

Final Rule

The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) provides the Food and Drug Administration (FDA) authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Tobacco Control Act, permits FDA to issue regulations deeming other tobacco products to be subject to the FD&C Act. This rule would deem additional products meeting the statutory definition of "tobacco product" to be subject to the FD&C Act, and would specify additional restrictions.

None

5/10/2016

CTP

 Published

Requirements for the Testing and Reporting of Tobacco Product Constituents, Ingredients, and Additives

0910-AG59

Proposed Rule

The Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act, requires the Food and Drug Administration to promulgate regulations that require the testing and reporting of tobacco product constituents, ingredients, and additives, including smoke constituents, that the Agency determines should be tested to protect the public health.

 

Statutory 4/30/2013

4/30/2018

CTP

 

Registration of Food Facilities: Amendments to Food Facility Registration Requirements

0910-AG69

Final Rule

This rule will amend FDA's regulation for food facility registration by requiring that food facilities submit registrations in an electronic format beginning in 2016, and by codifying the requirement that facilities renew their registrations with FDA every two years. In addition, the rule will amend the definition of "retail food establishment," and will also require certain additional information be submitted as part of food facility registration.

None

7/14/2016

OC

 Published

Use of Certain Symbols in Labeling

0910-AG74

Final Rule

The purpose of this rule is to allow for the optional inclusion in device labeling of stand-alone symbols if certain requirements are met. The rule also revises prescription device labeling regulations to allow the use of the symbol statement "Rx only" on the labeling of prescription devices.

None

6/15/2016

CDRH

 Published

Establishment Registration and Product Listing for Tobacco Products

0910-AG89

Proposed Rule

This regulation would prescribe the form and content of domestic establishment registration and product listing for manufacturers of tobacco products. The regulation would also establish a requirement for foreign establishment registration and listing for manufacturers of tobacco products, and prescribe the form and manner of such registration and listing.

None

8/31/2018

CTP

 

Postmarket Safety Reporting for Combination Products

0910-AF82

Final Rule

The rule would describe the postmarket safety reporting requirements for combination products (combinations of a drug, device, and/or biological product). The rule would clarify that a combination product is subject to the reporting requirements associated with the type of marketing application under which the product is approved, licensed, or cleared, and to certain additional, specified reporting requirements depending on the types of constituent parts (drug, device, or biological product) of which it is comprised. The regulation would ensure the consistency and appropriateness of postmarket safety reporting for combination products while minimizing duplicative reporting requirements.

None

12/31/2016

OC

 

Food Labeling: Revision of the Nutrition and Supplement Facts Labels

0910-AF22

Final Rule

FDA is amending the labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the label to assist consumers in maintaining healthy dietary practices. The rule will modernize the nutrition information found on the Nutrition Facts label, as well as the format and appearance of the label. On July 27, 2015, FDA issued a supplemental notice of proposed rulemaking accepting comments on limited additional provisions until October 13, 2015. Also on July 27, 2015, FDA reopened the comment period on the proposed rule as to specific documents until September 25, 2015. In addition, in response to requests for the raw data related to FDA’s consumer studies on the nutrition label, FDA issued a notice on September 10, 2015 to make the raw data available for comment until October 13, 2015 and extended the comment period for the July 27, 2015 reopening as to specific documents to October 13, 2015. On October 20, 2015, FDA extended the comment period for the consumer studies and the supplemental proposal to October 23, 2015.

None

5/27/2016

CFSAN

 Published

Requirements for Tobacco Product Manufacturing Practice

0910-AH22

Proposed Rule

FDA is proposing requirements that govern the methods used in, and the facilities and controls used for, the pre-production design validation, manufacture, packing, and storage of tobacco products.

None

5/31/2017

CTP

 

 Updated Standards for Labeling of Pet Food

0910-AG09

Proposed Rule

FDA is proposing updated standards for the labeling of pet food that include nutritional and ingredient information, as well as style and formatting standards. FDA is taking this action to provide pet owners and animal health professionals more complete and consistent information about the nutrient content and ingredient composition of pet food products.

Statutory 9/27/2009

4/30/2017

CVM

 

Reports of Distribution and Sales Information for Antimicrobial Active Ingredients Used in Food-Producing Animals

0910-AG45

Final Rule

This final rule will require that the sponsor of each approved or conditionally approved antimicrobial new animal drug product submit an annual report to the Food and Drug Administration (FDA or Agency) on the amount of each antimicrobial active ingredient in the drug product that is sold or distributed for use in food-producing animals, including any distributor-labeled product. In addition to codifying these requirements, FDA is exploring other requirements for the collection of additional drug distribution data.

None

5/11/2016

CVM

Published

Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices

0910-AG48

Final Rule

This rule will amend FDA's regulations on acceptance of data for medical devices to require that clinical investigations submitted in support of a research or marketing application submission be conducted in accordance with good clinical practice if conducted outside the United States and in accordance with FDA's regulations if conducted in the United States.

None

12/31/2016

OC

 

 Focused Mitigation Strategies To Protect Food Against Intentional Adulteration 

0910-AG63

Final Rule

This rule would require domestic and foreign food facilities that are required to register under the Federal Food, Drug, and Cosmetic Act to address hazards that may be intentionally introduced by acts of terrorism. These food facilities would be required to identify and implement focused mitigation strategies to significantly minimize or prevent significant vulnerabilities identified at actionable process steps in a food operation.

Judicial 5/31/2016

5/27/2016

OFVM

 Published

Regulations on Fixed-Dose Combination and Co-Packaged Drug and/or Biological Products

0910-AF89

Final Rule

The rule would amend FDA regulations on fixed-combination prescription and over-the-counter (OTC) drugs. The rule would 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 rule would create a single set of regulations for prescription and OTC combination drugs, and codify existing policy on what kinds of studies are needed to show that the combination drug requirements are met. The rule also would: Apply these regulations to combinations of biological drug products and to drug-biological product combinations; clarify application of FDA's requirements regarding fixed-dose combinations to certain natural source drugs and certain synthetic drugs; establish circumstances under which the agency might waive the combination requirements for a particular drug or biological product; and address the issue of co-packaging.

None

Long Term Action

CDER

 

Abbreviated New Drug Applications and 505(b)(2) Applications

0910-AF97

Final Rule

This rule would make changes to certain procedures for Abbreviated New Drug Applications and 505(b)(2) applications relating to patent certifications, notice to patent owners and application holders, the availability of a 30-month stay of approval, amendments and supplements, and the types of bioavailability and bioequivalence data that can be used to support these applications.

None

10/6/2016

CDER

 Published

Pediatric Study Plan Requirements for New Drug and Biologics License Applications 

0910-AG93

Proposed Rule

FDA is proposing requirements for the content of initial pediatric study plans, a process for reaching agreement with FDA on initial plans, and a process for amending pediatric study plans.

None

12/31/2017

CDER

 

Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products

0910-AG94

Final Rule

This rule would amend the regulations regarding new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license application (BLAs) to revise and clarify procedures for changes to the labeling of an approved drug to reflect certain types of newly acquired information in advance of FDA's review of such change.

None

04/30/2017

CDER

 

Sunlamp Products; Proposed 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. For example, incorporating specific elements of the International Electrotechnical Commission's standard by reference will allow the Agency to take advantage of the expertise of the international committees involved in the modernization of the international standard, and, thus, save Agency resources. FDA also plans to include changes to the required warning label.

None

11/30/2016

CDRH

 

Food Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or Distilled Foods

0910-AH00

Final Rule

This rule would establish requirements concerning compliance for using a "gluten-free" labeling claim for those foods for which there is no scientifically valid analytical method available that can reliably detect and accurately quantify the presence of 20 parts per million (ppm) gluten in the food.

Statutory

8/4/2008

4/30/2017

CFSAN

 

Banned Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove 

0910-AH02

Final Rule

FDA has determined that a subset of surgeon and patient exam gloves that are powdered and that represent a modest share of the market present an unreasonable and substantial risk of illness or injury that cannot be corrected by a change in labeling. These gloves are powdered natural rubber latex surgeon's gloves, powdered synthetic latex surgeon's gloves, powdered natural rubber latex patient examination gloves, powdered synthetic patient examination gloves, and absorbable powder for lubricating a surgeon's glove. Consequently, FDA is proposing to ban these devices.

None

1/31/2017

CDRH

 

Radiology Devices; Designation of Special Controls for the Computed Tomography X-Ray System 

0910-AH03

Proposed Rule

The proposed rule would establish special controls for the computed tomography (CT) X-ray system. A CT X- ray system is a diagnostic X-ray imaging system intended to produce cross-sectional images of the body through use of a computer to reconstruct an image from the same axial plane taken at different angles. High doses of ionizing radiation can cause acute (deterministic) effects such as burns, reddening of the skin, cataracts, hair loss, sterility, and, in extremely high doses, radiation poisoning. The design of a CT X-ray system should balance the benefits of the device (i.e., the ability of the device to produce a diagnostic quality image) with the known risks (e.g., exposure to ionizing radiation). FDA is establishing proposed special controls, which are necessary to provide reasonable assurance of the safety and effectiveness of a class II CT X-ray system.

None

8/31/2017

CDRH

 

Mammography Quality Standards Act; Regulatory Amendments

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

2/28/2017

CDRH

 Regulatory Plan Entry

Investigational Tobacco Product Applications

0910-AH06

Proposed Rule

The proposed regulations will establish the conditions for exempting investigational tobacco products (ITPs) from certain FD&C Act requirements.  The proposed rule will set out the proposed procedures to obtain an investigational tobacco product application.   It also will delineate the responsibilities of sponsors, institutional review boards, and clinical investigators with respect to clinical investigations of ITPs.  Furthermore, the proposed rule will set forth informed consent requirements and will specify recordkeeping and reporting requirements.

None

3/31/2018

CTP

 

Format and Content of Reports Intended to Demonstrate Substantial Equivalence

0910-AG96

Proposed Rule

This regulation would establish the format and content of reports intended to demonstrate substantial equivalence. This regulation also would provide information as to how the Agency will review and act on these submissions.

None

11/30/2016

CTP

 

Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application and Animal Drugs

0910-AA49

Final Rule

The rule will reorganize, consolidate, clarify, and modify current regulations concerning who must register establishments and list human drugs, including certain biological drugs, and animal drugs. These regulations contain information on when, how, and where to register drug establishments and list drugs, and what information must be submitted. They also address National Drug Codes.

None

7/31/2016

CDER

 Published

Additions and Modifications to the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness

0910-AH08

Final Rule

This rule would update and amend the list of drug products to add entries to or modify existing entries the list of drug products that may not be compounded 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.

Not more than 18 months following publication of the proposed rule

10/7/2016

CDER

 Published

Investigational New Drug Application Annual Reporting

0910-AH07

Proposed Rule

This proposed rule would revise the requirements concerning annual reports submitted to investigational new drug applications (INDs) by replacing the current annual reporting requirement with a requirement that is generally consistent with the format, content, and timing of submission of the development safety update report devised by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

None

4/30/2017

CDER

 

General and Plastic Surgery Devices: Sunlamp Products

0910-AH14

Final Rule

This rule would apply device restrictions to sunlamp products. 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 sunlamp product use at young ages, as well as frequently using sunlamp products, both increase 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. Sunlamp products incorporate ultraviolet (UV) lamps and include devices such as UV tanning beds and booths. People who use sunlamp products are at increased risk of developing skin cancer and other illnesses, and sustaining injuries.

None

2/28/2017

CDRH

Regulatory Plan Entry 

Current Good Manufacturing Practice for Outsourcing Facilities

0910-AH09

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

7/31/2017

CDER

 

Substances Generally Recognized as Safe

0910-AH15

Final Rule

This final rule relates to the process for informing FDA of a determination that the use of a substance in human food or in animal feed is not subject to the food additive premarket approval requirements because such use is generally recognized as safe (GRAS). FDA has proposed to replace the voluntary GRAS affirmation petition process, under which FDA issues a regulation affirming the use of a substance as GRAS, with a voluntary process to notify FDA of a determination that a particular use of a substance is GRAS. FDA also proposed to clarify when use of a substance is GRAS.

 

 

Judicial 8/31/2016

 

8/17/2016

CFSAN

 Published

National Standards for Licensure of Wholesale Distributors and Third-Party Logistics Providers  

0910-AH11

Proposed Rule

The  proposed 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.

Statutory
11/27/2015

6/30/2017

CDER

 

Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs or Devices

0910-AH19

Final Rule

The rule will describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product. This action is intended to provide direction to regulated industry and to help avoid consumer confusion.

None

12/31/2016

CTP

 

Conditional Approval of New Animal Drugs for Minor Use and Minor Species

0910-AG07

Proposed Rule

The Minor Use and Minor Species Animal Health Act of 2004 established new regulatory procedures intended to make more medications legally available to veterinarians and animal owners for the treatment of minor animal species, as well as uncommon diseases in major animal species. FDA has the authority to provide for animal drug conditional approval after all safety and manufacturing components of a new animal drug approval have been met. For the effectiveness component of  a new animal drug review, a reasonable expectation of effectiveness must be established prior to conditional approval. Sponsors then have up to five years to complete full effectiveness and achieve a complete new animal drug approval.

Statutory
2/2/2008

6/30/2017

CVM

 

List of Bulk Drug Substances That May Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act

0910-AH29

Proposed Rule

As required under section 503A of the Food, Drug, and Cosmetic Act (FD&C Act), FDA is developing a list of bulk drug substances that are not the subject of an applicable United States Pharmacopeia or National Formulary monograph, or a component of an FDA-approved drug, that can be used to compound drug products eligible for the exemptions identified in section 503A of the FD&C Act. This proposed rule will identify the criteria proposed for evaluating bulk drug substances for inclusion on the list and the first 10 substances considered. It will identify those substances FDA proposes for inclusion on, the list and those substances FDA proposes not be placed on the list.

None

11/30/2016

CDER

 

FDA Review and Action on Over-the-Counter Time and Extent Applications

0910-AH30

Final Rule

FDA is amending its over-the-counter (OTC) drug regulations. The final rule will supplement the time and extent application (TEA) process for OTC drug products by establishing timelines and measurable metrics for FDA’s review of non-sunscreen TEAs, as required by the Sunscreen Innovation Act (SIA). The final rule will also address other changes to make the TEA process more efficient.

Statutory 2/26/2017 

02/28/2017

CDER

 

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

6/30/2017

CVM

 

New Animal Drugs: Updating Tolerances for Residues in New Animal Drugs in Food

0910-AG17

Proposed Rule

FDA is proposing to 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, the Agency is proposing to 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

Supplemental NPRM
3/31/2017

CVM

 

Abbreviated New Animal Drug Applications and Phased Review Process for New Animal Drug Applications 

0910-AG46

Proposed Rule

The Generic Animal Drug and Patent Restoration Act (GADPTRA) authorized abbreviated applications for the approval of a new animal drug. This rulemaking is intended to establish the procedural requirements for the submission and approval of generic new animal drug applications.

Statutory
11/16/1989

6/30/2017

CVM

 

Labeling Requirement for Approved and Conditionally Approved New Animal Drugs

0910-AH27

Proposed Rule

FDA is proposing updated regulations for the labeling of new animal drugs and new regulations that specify the format and content of labeling for prescription (Rx) new animal products, new animal drug products for use in feed, and over-the-counter (OTC) new animal drug products. The objective of the proposed rule is to protect the health of animals by providing more drug information in a more uniform format on the animal drug label. FDA is taking this action to provide pet owners and animal health professionals more complete and consistent information about approved and conditionally approved new animal drugs.

None

6/30/2017

CVM

 

Direct Food Substances Affirmed as Generally Recognized as Safe; Partially Hydrogenated Menhaden Oil and Rapeseed Oil 

0910-AH28

Proposed Rule

The proposed rule would amend two existing regulations that affirm "generally recognized as safe” (GRAS) status by removing partially hydrogenated menhaden oil and partially hydrogenated rapeseed oil. We are taking this action in light of our recent determination that partially hydrogenated oils are no longer considered to be GRAS.

None

11/30/2016

CFSAN

 

User Fees for FDA's Third-Party Accreditation Program for Food and Feed

0910-AH23

Final Rule

This rule would establish a reimbursement (user fee) program to assess fees and require reimbursement for the work performed to establish and administer the Third-Party Program under FDA's Food Safety Modernization Act.

None

11/30/2016

OFVM

 

Regulations on Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act

0910-AH10

Proposed Rule

FDA will propose regulations to define and implement certain statutory conditions under which compounded products may qualify for exemptions from certain requirements.

None

12/31/2017

CDER

 

Internal Agency Review of Decisions; Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and Radiological Health

0910-AH37

Proposed Rule

FDA is proposing to implement 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 codify the procedures and timeframes that apply to supervisory review of significant decisions pertaining to devices. The FDA is also proposing regulations to 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.

None

11/30/2016

CDRH

 

 Ear, Nose, and Throat, Gastroenterology-Urology, General and Plastic Surgery, Neurological, Orthopedic, and Radiology Devices; Reprocessing of Reusable Medical Devices Designation of Special Controls

0910-AH39

Proposed Rule

The FDA is proposing to establish special controls for the following class II reprocessed reusable medical devices, including but not limited to: Bronchoscopes and accessories; Gastroenterology and Urology Endoscopes that have elevator channels, including duodenoscopes, panendoscopes, pancreatoscopes, mini-endoscopes, choledochoscopes, and endoscopic ultrasound systems; Colonoscopes and Enteroscopes; Neurological Endoscopes; Automated Endoscope Reprocessors; Ear Nose and Throat (ENT) Endoscopes and accessories, including esophagoscopes, nasopharyngoscopes, laryngoscopes, and mediastinoscopes; Arthroscopes and accessories; Laparoscopic instruments and accessories; Electrosurgical instruments and accessories; and Robotically-assisted surgical devices. FDA is proposing this action, based on the scientific determination that general controls alone are insufficient to provide reasonable assurance of the safety and effectiveness of these devices, and there is sufficient scientific information to establish special controls for the reprocessing of these reusable devices.

None

2/28/2017

CDRH

 

Renaming Various Devices as Powered Laparoscopic Tissue Fragmentation Devices; Designation of Special Controls

0910-AH38

Proposed Rule

This proposal addresses a set of devices that includes laparoscopic power morcellators. The rule is being proposed in order to consolidate and update requirements for various medical devices used in obstetrical or gynecological surgeries that may pose a risk of up-staging cancer in the patient. The consolidation (renaming) will create a single set of requirements to address the risks of such devices, and the update will revise general controls and apply special controls to mitigate the risk and provide adequate assurance of safety and effectiveness. All subject devices are already class 2, and the rule would not up-classify devices.

None

1/31/2017

CDRH

 

Responsibilities for the Initiation and Conduct of Clinical Investigations 

0910-AH32

Proposed Rule

The proposed rule would update the 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.

None

5/31/2017

CDER

 

Postmarketing Safety Reporting Requirements for Human Drug and Biological Products

0910-AA97

Final Rule

The final rule would amend the postmarketing expedited and periodic safety reporting regulations for human drugs and biological products to revise certain definitions and reporting formats as recommended by the International Council on Harmonisation and to define new terms; to add to or revise current reporting requirements; to revise certain reporting time frames; and to propose other revisions to these regulations to 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

8/30/2017

CDER

 

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

Proposed 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

NPRM Published 10/18/2016
NPRM Comment Period End 1/3/2017

CDER

 

Use of Ozone Depleting Substances

0910-AH36

Proposed Rule

The Food and Drug Administration (FDA or the Agency) is proposing to amend its regulation (21 CFR 2.125) on uses of ozone-depleting substances (ODSs), including chlorofluorocarbons (CFCs), to remove designations for certain products as essential uses under the Clean Air Act. Essential-use products are exempt from FDA’s ban on the use of CFC propellants in FDA-regulated products and the Environmental Protection Agency’s (EPA’s) ban on the use of CFCs and other ODSs in pressurized dispensers. This action, if finalized, will remove essential use exemptions for sterile aerosol talc administered intrapleurally by thoracoscopy for human use, metered-dose atropine sulfate aerosol human drugs administered by oral inhalation, and anesthetic drugs for topical use on accessible mucous membranes of humans where a cannula is used for application. FDA is proposing this action because alternative products that do not use ODSs are now available and because these products are no longer being marketed in approved versions that contain ODSs. On June 29, 2015, FDA published a notice and request for comment concerning its tentative conclusion that these products are no longer an essential use under the Clean Air Act (80 FR 36937). The Agency received no comments concerning removal of essential use designations for sterile aerosol talc and metered-dose atropine sulfate, and is proposing to remove these designations by direct final rule and a companion proposed rule in the event adverse comments are received. FDA received one comment concerning removal of anesthetic drugs for topical use in response to its 2015 notice and request for comment, and is proposing to remove this exemption through a separate notice. Because these products are not currently sold in the approved form, no significant economic impact is anticipated.

None

NPRM Published 10/26/2016
 

NPRM Comment Period End 12/31/2016

CDER

 

Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements

0910-AC53

Final Rule

The Food and Drug Administration is amending its current good manufacturing practice regulations and other regulations to clarify and strengthen requirements for the label, color, dedication, and design of medical gas containers and closures. Despite existing regulatory requirements and industry standards for medical gases, there have been repeated incidents in which cryogenic containers of harmful industrial gases have been connected to medical oxygen supply systems in hospitals and nursing homes and subsequently administered to patients. These incidents have resulted in death and serious injury. There have also been several incidents involving high-pressure medical gas cylinders that have resulted in death and injuries to patients. These amendments, together with existing regulations, are intended to ensure that the types of incidents that have occurred in the past, as well as other types of foreseeable and potentially deadly medical gas accidents, do not occur in the future. FDA has described a number of proposals in the proposed rule including requiring that gas use outlet connections on portable cryogenic medical gas containers be securely attached to the valve body. 

None

11/30/2016

CDER

 Published

Premarket Tobacco Product Applications

0910-AH44

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.

None

9/30/2017

CTP

 

Record-keeping Requirements for Certain Submissions to FDA

0910-AH45

Proposed Rule

The Food and Drug Administration is proposing regulations to establish recordkeeping requirements for certain submissions to FDA. This regulation would establish recordkeeping requirements for premarket tobacco product applications, modified risk tobacco product applications, requests for exemption from substantial equivalence, and abbreviated reports. This regulation would also establish recordkeeping requirements for tobacco products that were commercially marketed (other than exclusively in test markets) in the United States as of February 15, 2007.

None

7/31/2017

CTP

 

Patient Medication Information

0910-AH33

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 used, dispensed, or administered on an outpatient basis. The proposed rule would include requirements for Patient Medication Information development, consumer testing, and distribution. The proposed rule would require clear and concise 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

2/28/2017

CDER

Regulatory Plan Entry

Second 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-AH34

Proposed Rule

As required under section 503A of the Food, Drug, and Cosmetic Act (FD&C Act), FDA is developing a list of bulk drug substances that are not the subject of a United States Pharmacopeia or National Formulary monograph, or a component of an FDA-approved drug, that can be used to compound drug products eligible for the exemptions identified in that section (List). In fall 2016, we expect to publish an NPRM proposing the criteria for evaluating bulk drug substances for the List, identifying 10 substances nominated for the list and whether FDA proposes the substance be placed on the List. This proposed rule will identify 15-20 additional bulk drug substances nominated for the List and whether FDA proposes the substance be included on the List, or not included on the List.

None

11/30/2016

CDER

 

Food Labeling: Calorie Labeling of Articles of Food in Vending Machines; Front of Package Font Size and Signage for Gums, Mints and Roll Candy Sold From Vending Machines

0910-AH42

Proposed Rule

The Food and Drug Administration (FDA) is amending its regulations on providing calorie declarations for certain articles of food sold from vending machines.   Foods sold from a vending machine are not required to disclose the calorie information if the prospective purchaser can view visible nutrition information at the point of purchase, this includes Front of Pack (FOP) labeling.  This proposed rule would change the font size requirements for FOP labeling in glass front vending machines.  In addition, the proposed rule would provide additional flexibility for calorie labeling of gums, mints and roll candy when grouped together in glass front vending machines since there are space restraints for labeling these foods.

None

2/28/2017

CFSAN

 

Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease

0910-AH43

Proposed Rule

The Food and Drug Administration (FDA or we) is proposing to amend its 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

6/30/2017

CFSAN

 

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