Regulatory Focus™ > News Articles > FDA, HHS Release Regulatory Agenda for 2013

FDA, HHS Release Regulatory Agenda for 2013

Posted 02 January 2013 | By Alexander Gaffney, RAC 

The US Department of Health and Human Services (DHHS) has released its Unified Agenda for the coming year, including dozens of final and proposed regulations set to be released by the US Food and Drug Administration (FDA).

The final list, which does not include draft or final guidance documents, which are contained in other center-specific lists, is nevertheless extensive. Many of the planned regulations are holdovers from prior lists, but several are new.

One, in particular, calls for the "Revision of postmarketing reporting requirements" for drugs experiencing a shortage situation in the case of discontinuance or supply interruptions. The changes, called for by the recently-passed FDA Safety and Innovation Act, include the definition of high-need drugs, how information about impending shortages should be distributed to stakeholders, and more.

Other new additions include new regulations regarding the review of over-the-counter cough and cold combination products and numerous food labeling requirements that would apply to nutritional and dietary supplement products.

Elsewhere in the Unified Agenda, HHS has reiterated its support for two proposed regulations aimed at enhancing research protections for clinical trials. The first, proposed by the NIH, "Expanded Registration and Results Reporting at ClinicalTrials.gov" calls for new procedures to govern the registration and reporting of results and adverse events. The second, Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, announces that the Office of Human Research Protections (OHRP) is "considering revisions to the current human subjects regulations in order to strengthen protections for research subjects." The proposed regulation has been in the works for at least a year, and is in the draft stages of regulation until at least April 2013.

For a complete listing of the Unified Agenda, please visit this link. The list is maintained by the Office of Information and Regulatory Affairs (OIRA), which must approve each of the regulations individually. A condensed version of the list can be found below.


FDA

Pre-rule Stage

Over-the-Counter (OTC) Drug Review--Sunscreen Products

0910-AF43

FDA

Proposed Rule Stage

Food Labeling; Revision of the Nutrition and Supplement Facts Labels

0910-AF22

FDA

Proposed Rule Stage

Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed in One Eating Occasion; Dual Column Labeling; and Modifying the Reference Amounts Customarily Consumed

0910-AF23

FDA

Proposed Rule Stage

Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products

0910-AF31

FDA

Proposed Rule Stage

Over-the-Counter (OTC) Drug Review--Internal Analgesic Products

0910-AF36

FDA

Proposed Rule Stage

Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products

0910-AF69

FDA

Proposed Rule Stage

Laser Products; Amendment to Performance Standard

0910-AF87

FDA

Proposed Rule Stage

Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals

0910-AG10

FDA

Proposed Rule Stage

Over-the-Counter (OTC) Drug Review--Pediatric Dosing for Cough/Cold Products

0910-AG12

FDA

Proposed Rule Stage

Electronic Distribution of Prescribing Information for Human Drugs Including Biological Products

0910-AG18

FDA

Proposed Rule Stage

Produce Safety Regulation

0910-AG35

FDA

Proposed Rule Stage

Hazard Analysis and Risk-Based Preventive Controls

0910-AG36

FDA

Proposed Rule Stage

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

0910-AG38

FDA

Proposed Rule Stage

Food Labeling; Dietary Guidance Statements

0910-AG50

FDA

Proposed Rule Stage

General Hospital and Personal Use Devices: Issuance of Draft Special Controls Guidance for Infusion Pumps

0910-AG54

FDA

Proposed Rule Stage

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

0910-AG59

FDA

Proposed Rule Stage

Foreign Supplier Verification Program

0910-AG64

FDA

Proposed Rule Stage

Accreditation of Third Parties To Conduct Food Safety Audits and for Other Related Purposes

0910-AG66

FDA

Proposed Rule Stage

Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals--Components

0910-AG70

FDA

Proposed Rule Stage

Use of Symbols in Labeling

0910-AG74

FDA

Proposed Rule Stage

Requirements for the Submission of Data Needed to Calculate User Fees for Manufacturers and Importers of Tobacco Products

0910-AG81

FDA

Proposed Rule Stage

Food Labeling: Hard Candies and Breath Mints

0910-AG82

FDA

Proposed Rule Stage

Food Labeling: Serving Sizes; Reference Amounts for Candies

0910-AG83

FDA

Proposed Rule Stage

Revision of Postmarketing Reporting Requirements Discontinuance or Interruption in Supply of Certain Products (Drug Shortages)

0910-AG88

FDA

Proposed Rule Stage

Establishment Registration and Product Listing for Tobacco Products

0910-AG89

FDA

Proposed Rule Stage

Public Information in Tobacco Marketing Applications

0910-AG90

FDA

Final Rule Stage

Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Records and Reports; and Quality Factors

0910-AF27

FDA

Final Rule Stage

Over-the-Counter (OTC) Drug Review--Cough/Cold (Combination) Products

0910-AF33

FDA

Final Rule Stage

Current Good Manufacturing Practice for Combination Products

0910-AF81

FDA

Final Rule Stage

Postmarket Safety Reporting for Combination Products

0910-AF82

FDA

Final Rule Stage

Medical Device Reporting; Electronic Submission Requirements

0910-AF86

FDA

Final Rule Stage

Unique Device Identification

0910-AG31

FDA

Final Rule Stage

Food Labeling: Nutrition Labeling for Food Sold in Vending Machines

0910-AG56

FDA

Final Rule Stage

Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments

0910-AG57

FDA

Final Rule Stage

Additional Safeguards for Children in Clinical Investigation of FDA-Regulated Products

0910-AG71

FDA

Final Rule Stage

Food Labeling; Gluten-Free Labeling of Foods

0910-AG84

OASH

Proposed Rule Stage

Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators

0937-AA02

NIH

Proposed Rule Stage

Expanded Registration and Results Reporting at ClinicalTrials.gov

0925-AA55



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