Outline of Recent Revisions to FDA Regulatory Procedures Manual

From the FDA website found here.

2012 Revisions and Updates

• 08/16/2012: Chapter 9 of the Regulatory Procedures Manual¹ (RPM) was revised and updated, as detailed below.
  • Chapter 9 - Import Operations and Actions
    • Section 9-1, subsection "Scope and Purpose," was revised to include the following Tobacco Acts - Federal Cigarette Labeling and Advertising Act and Comprehensive Smoking Tobacco Health and Education Act of 1986. Section 9-6, "Recommendation Based on Multiple Samples," was revised to include the amount "at least 25%" in paragraphs 1(b), 2(b), and 3(b), and to also include the following language, "FDA may consider additional information in conjunction with sample analysis when considering whether to recommend products from a manufacturer, shipper, geographic area, or country for detention without physical examination, such as the results of foreign inspections and other types of information discussed in this subchapter." Section 9-15, subsection "Background," was revised to clarify section 801(d)(3)(B) of the Act.
    • Section 9-21, Exhibits - Exhibit 9-1 was deleted so please refer to Exhibit 9-6 instead. Exhibit 9-2 was updated with the current version. Exhibit 9-3 was revised to omit "tobacco products" from the following sentence, "These laws are designed to protect you from, among other things, unsafe or misrepresented foods, drugs, biologics, cosmetics, devices, and other articles." The title of Exhibit 9-11 had the words "for Special Events" added. Exhibit 9-12 was deleted as a duplication of Exhibit 9-6. Exhibit 9-13 was removed.
• 08/01/2012: Chapter 4 of the Regulatory Procedures Manual² (RPM) was revised and updated, as detailed below.
  • Chapter 4 - Advisory Actions
    • CFSAN - Section 4-1-4, item #6, was revised to reflect new direct reference authority to District Offices to issue advisory letters (i.e., Warning Letters and Untitled Letters) that cite deviations from the GMP regulation 21 CFR Part 110 as the basis to support that a product is adulterated under section 402(a)(4) of the Act, except for cases that include references to environmental testing or that address allergen cross-contact situations.
• 07/30/2012: Chapters 1, 2, 5, 7, 8, and 11 of the Regulatory Procedures Manual³ (RPM) were revised and updated, as detailed below.
  • Chapter 1 - Regulatory Organization
    • Table of Contents - CDER and CDRH mail codes were removed.
    • CFSAN - Section 1-6-2, paragraph #2, was changed to reflect team name change in Office of Cosmetics and Colors to Cosmetics Activities Team. Section 1-6-4, paragraph #5, was revised to include programmatic roles and responsibilities for Division of Dietary Supplement programs by adding "technicial consultation on dietary supplement cGMP inspections." Also updated telephone list.
    • CTP: Section 1-8 was updated to include Center for Tobacco Products (CTP) and Section 1-8-1 included three functional units of Office of Compliance and Enforcement.
  • Chapter 2 - FDA Authority
    • Table of Contents was revised to include Section 2-2-1 FDA Food Safety Modernization Act of 2011.
    • Weblinks were revised in the following sections: Section 2-1-2, for court rules for each circuit; Section 2-2-1, for passage of the FDA Food Safety Modernization Act (FSMA); Section 2-2-5; Section 2-2-12, for consumer updates; Section 2-2-29, for the statute and new regulations; and Section 2-3-3, for the Policy Guidance Help System.
  • Chapter 5 - Administrative Actions
    • CBER - Section 5-6 was revised to clarify the term "Revocation." All subsections in Section 5-7 were updated to include current regulations under section 361 of the Public Health Service Act and to streamline the process for issuing an order related to HCT/Ps. Sections 5-7-4, 5-7-5, and 5-7-6 included the acronym BTCB/DCM.
    • CTP - Section 5-8 was revised for "And No-Tobacco-Sale Orders" and Item #6, "Tobacco Products," was added for civil money penalties violations of tobacco product requirements. Section 5-8-3 was revised for CTP initiating CMP actions against tobacco retailers.
  • Chapter 7 - Recall Procedures
    • CTP - Section 7-5-3, paragraph #6, was revised to describe the FDA's notification and recall authority of tobacco products under provisions section 908(a) and 908(c) of the Act. Section 7-10 was updated to include Attachment I for Recall of Tobacco Products.
  • Chapter 8 - Emergency Procedures
    • The following sections were revised: Section 8-3-1, to clarify examples of highly transmissible diseases; Section 8-5-2, to clarify acceptable communication methods; and Section 8-5-4, paragraph #1, for grammar corrections.
    • CTP - Section 8-5-5 was updated to include CTP's office address.
    • FDA/Emergency Operations Center, OCM/OC, was revised for updated room number.
  • Chapter 11 - Glossary
    • Chapter was revised to include terms and definitions for Civil Money Penalties (CMPs), CMP, CTP, No-Tobacco-Sale orders, and tobacco retail compliance check inspections.
• 07/13/2012: Revised Debarment List⁴ - Glen R. Justice added.
• 07/13/2012: Revised Debarment List⁵ - Sami Arshak Yanikian added.
• 05/25/2012: Chapter 4 of the Regulatory Procedures Manual⁶ (RPM) has been revised and updated, as detailed below.
  • Chapter 4 - Advisory Actions
    • CFSAN: These sections of the RPM are being changed to establish the appropriate Warning Letter language that will include violations that are materially related to food safety. Sections 4-1-10, 4-1-11 and 4-1-17 are being changed to reflect the implementation of the fee provisions of Section 107 of the FDA Food Safety Modernization Act (FSMA), amended Section 743 of the Federal Food, Drug, and Cosmetic Act (the Act) to provide FDA with the authority to assess and collect fees from the responsible party for each domestic and the US agent for each foreign facility subject to a reinspection to cover reinspection related costs.
    • CTP: Sections 4-1-4, 4-1-8, 4-1-10, and 4-1-18 are being changed to update CTP's policy and scope.
    • CDER: Sections 4-1-4, 4-1-10, and 4-1-15 are being changed to reflect the CDER new organization.
    • CFSAN: Section 4-1-4 to clarify language in paragraph #6 and 4-1-17 are being changed to add a new weblink cross-reference to 4-1-10.
    • Promotional activities: 4-1-5 has been clarified and modified to address websites.
    • Section 4-2 has been edited to clarify that Center concurrence is required prior to issuing Untitled Letters unless direct reference has been granted.
• 05/15/2012: Revised Debarment List⁷ - Daphne I. Panagotacos added.
• 05/15/2012: Revised Debarment List⁸ - Jerome Lentini added.
• 05/14/2012: Revised Debarment List⁹ - David H.M. Phelps added.
• 05/14/2012: Revised Debarment List¹⁰ - Karen L. Blyth added.
• 04/16/2012: Revised Debarment List¹¹ - Jyotin Parikh added.
• 04/16/2012: Revised Debarment List¹² - Jose Concepcion added.
• 04/16/2012: Revised Debarment List¹³ - Ashish Macwan added.
• 04/16/2012: Revised Debarment List¹⁴ - Shashikant Shan added.
• 02/22/2012: Revised Debarment List¹⁵ - Stephen L. Marks added.
• 01/25/2012: Revised Debarment List¹⁶ - Yuri Izurieta added.
• 01/25/2012: Revised Debarment List¹⁷ - Anneri Izurieta added.