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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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RPM News 2013

 

  • 10/23/2013: Chapter 7 of the Regulatory Procedures Manual (RPM) was revised and updated, as detailed below

    • Changed the respective offices in ORA to reflect the 2012 ORA headquarters reorganization.
    • Sections 7-1, "Purpose" and 7-2, "Background" was revised to clarify the background of RPM Chapter 7.
    • Included "tobacco products" and "mandatory recall of food products" where appropriate in Section 7-2 "Background."
    • Section 7-3, "Summary of FDA Responsibilities and Procedures", paragraphs (2) and (3) was revised to include the following statements: "Determination that the action is a recall; Strategy; Classification" and "For food recalls conducted under Section 423 of the Act (as amended by Section 206 of the FDA Food Safety Modernization Act (FSMA), FDA ensures that a press release is published regarding the recall, as well as alerts and public notices; as appropriate under section 423(g) of the Act."
    • Section 7-3, "Summary of FDA Responsibilities and Procedures" was revised to include, "a firm refuses to recall or sub-recall after being requested or ordered to do so by the FDA."
    • Section 7-3-3, "Responsibilities and Procedures-Office of Enforcement and Import Operations/Division of Compliance Systems/Enforcement Systems Branch (HFC-240)," was revised to include, "DCS/ESB prepares the weekly Enforcement Report from ORA's reporting system, works with the Center recall contacts to modify the report as necessary and published the report to FDA's website."
    • Section 7-4, "Recall Enterprise System", deleted paragraph (7) "Providing the public with "real time" information about the FDA recall process." Replaced broken link to the recalls industry guidance webpage.
    • Section 7-5, "Initiation of a Recall", subsection 7-5-1, "Firm Initiated Recalls", was revised to reflect that the FDA may conduct informal discussions with a manufacturer or distributor that include voluntary recall as an option, and that FDA may also request a recall, as provided for under 21 CFR 7.45. Section 7-5-1, 2(b) "Notes", was revised to clarify the term "market withdrawal". Revised the title in Section 7-5-1, "Initiation of a Recall", paragraph (5) to read, "Firm Recall Communication and Notification", and to clarify guidance for a recalling firm to discuss recall communication and notifications with the FDA District Office Recall Coordinator before issuance. Included the following statement, "For tobacco products, the Center for Tobacco Products should be contacted for guidance on any recall communications and notifications submitted by the recalling firm."
    • Deleted Interstate Milk Shipments from Section 7-5-3, "FDA Mandated Recalls" and the following statement, "If the recall is FDA-ordered, in certain situations, the agency will issue a written order to the firm to recall." Included Mandatory Recall Authority under Section 423(a) of the FD&C Act in paragraph (6) under Section 7-5-3, "FDA Mandated Recalls."
    • Section 7-6, "Recall Classification and Strategy" revised paragraph (4) to read, "Updates RES with classification, audit strategy, and any recommendations."
    • Section 7-6-2, "Classification Process", was revised to read "As appropriate, before classifying a recall, the CRU may make a determination that the action is a recall under the applicable definition of a recall."
    • Section 7-7, "Notifications and Public Warning", subsection 7-7-1, "Reports and Reporting Procedures, paragraph (2), deleted the following statement, "They will so advice the CRU, which will then update the FDA web page by reposting the recall record."
    • Section 7-7-3, "Public Warning", was revised to read, "Certain recall information (e.g., press releases) are posted on FDA's Internet website ("Recalls, Market Withdrawals, and Safety Alerts"). In addition, all industry product removal or corrective actions classified by the agency as recalls will be included in FDA's weekly Enforcement Report web page." Deleted the following paragraphs in section 7-7-3: "All recall alerts and recommendations submitted to the CRUs will, unless determined by the CRU at the outset to be market withdrawals or non-classifiable, be immediately posted by the CRU on FDA's Recalls webpage. These recall postings will then be updated by the CRU as they are classified and/or when significant changes, recall extensions, etc., are provided by the district coordinators or otherwise brought to the attention of the CRU. Additionally, the Office of Public Affairs (OPA) web page manager will update the recall document with Internet addresses for any press statements issued either by FDA, a state agency, and/or the recalling firm" and paragraph (c) "Alerts the appropriate home district of the expected release of publicity and all statements (i)-(iii)."
    • Included "Tobacco" in Exhibit 7-4 "Model Recall Letter (Generic, All Centers)", where appropriate.
       
  • 05/01/2013: Chapter 9 of the Regulatory Procedures Manual (RPM) was revised and updated, as detailed below.

    • Chapter 9- Import Operations and Actions Changed the respective offices in ORA to reflect the 2012 ORA headquarters reorganization.
    • Section 9-1, Import Procedures, subsection Payment of Costs of Supervision of Relabeling and/or other Action, changed Inspector's to Investigator's.
    • Section 9-11, Supervisory Charges, subsection Preparation and Submission of Charge Sheet, updated the mailing address and contact information of the U.S. Customs and Border Protection, Revenue Division-Reimbursable Team for submitting copies of the Notice of Release and/or Notice of Refusal of a sample.
    • Section 9-13, Import Information Directives, subsection Approach, changed automatic detention to detention without physical examination. Subsection Import Alert and Clearance Procedures, changed the statement to read, "Upon clearance, DIO will issue the alert via electronic mail service (EMS), load the alert into the Compliance Management System (CMS) and provide appropriate screening in the national entry database."
    • Section 9-15, Import for Export, subsection Agency Contacts, changed the CFSAN, Office of Field Programs, Division of Enforcement, (HFS-606) to CFSAN, Office of Compliance, Division of Enforcement, (HFS-608).
    • Section 9-18, Communication Concerning Assessment of Civil Monetary Penalties by CBP in cases involving Imported Food, subsection Guidance for Industry and FDA Employees, updated the Division of Import's mailing address and contact information.
    • Exhibits 9-21, included Exhibit 9-12 Charges for Supervision Form FDA 790.
       
  • 04/04/2013: Draft Compliance Policy Guide Sec.100.250 Food Facility Registration- Human and Animal Food is now available. Federal Register notice of availability published on April 4, 2013 (78 FR 20326 ) @ https://www.federalregister.gov/articles/2013/04/04/2013-07809/food-facility-registration-human-and-animal-food-compliance-policy-guides-draft-availability 
  • 03/20/2013: Chapter 5 of the Regulatory Procedures Manual (RPM) was revised and updated, as detailed below.

    • Chapter 5- Administrative Actions- changed the respective offices in ORA to reflect the new ORA reorganization.
    • Section 5-3-3, Issuing and Terminating Detention Orders- included new telephone numbers of the following offices: FDA Emergency Operations Center (EOC); Division of Enforcement, Office of Compliance, CFSAN, and the Division of Compliance, Office of Surveillance and Compliance, CVM.
    • Section 5-5, Administrative Detention of Devices, Item #3 Detention Policy- included new telephone number of the Office of Compliance, CDRH.
    • Section 5-8, Civil Money Penalty and No-Tobacco-Sale orders, Tobacco Retailers Item #6 b.- included "that constitute a repeated violation."
    • Section 5-9-3, Initiating the Disqualification Process- included "Referred to Center (RTC) designations", and the following statement "The portion of the administrative record supporting issuance of Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) will include such document as:" Changed SOPs to procedures.
    • Section 5-9-4, Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE)- included the new distribution lists due to recent reorganizations and the move to the White Oak Campus. Included the current policy and new consolidated webpage for clinical investigator disqualification proceedings.
    • Section 5-9-5, Consent Agreements-included the following statement "The consent agreement may be signed by an FDA official as listed in Staff Manual Guide 1410.21- General Redelegations of Authority, paragraph 1.P. Updated link to the Staff Manual Guides.
    • Section 5-9-7, The Notice of Opportunity for Hearing (NOOH)- updated the current policy to reflect the publication of the final rule "Disqualification of a Clinical Investigator" (77 FR 25353, April 30, 2012). Included the following statement "The Center will forward the NOOH to the Center's FOI program for redaction and posting on FDA's webpage [www.fda.gov/DisqualificationProceedings]."
    • Exhibit 5-21, Sample NIDPOE-updated the current policy to reflect the publication of the final rule "Disqualification of a Clinical Investigator" (77 FR 25353, April 30, 2012)." Included the new distribution lists due to recent reorganizations and the move to the White Oak Campus.
    • Exhibit 5-22, Sample Consent Agreement-agreement with respect to use of Investigational Products paragraph #15-included "Disqualification Proceedings."
    • Exhibit 5-23, Sample Notice of Opportunity for Hearing (NOOH)-Included the new distribution lists due to recent reorganizations and the move to the White Oak Campus. 
     
  • 03/18/13: Revised Debarment List - Shu Bei Yuan added.
  • 03/18/13: Revised Debarment List - Adrian Vela added.
  • 03/18/13: Revised Debarment List - Richard Stowell added.
  • 03/18/13: Revised Debarment List - Cheng Yi Liang added.
  • 02/11/2013: Chapter 3 of the Regulatory Procedures Manual (RPM) was revised and updated, as detailed below.
    • Chapter 3- Commissioning
      Title of RPM Chapter 3 was changed from "Commissioning and Worksharing" to "Commissioning." DFSR changed to the Office of Partnerships throughout the RPM chapter to reflect the new ORA organization, and includes the current e-mail address as ORAHQOFFICEOFPARTNERSHIPS@fda.hhs.gov.
    • Section 3-1, Introduction; Objectives- is being revised to describe the meaning of a FDA commission and the responsibilities of a state and local official who are commissioned under FDA authority.
    • Section 3-2, Authorities- is being revised to clarify section 702(a)(2) of the Federal Food, Drug and Cosmetic Act.
    • Section 3-3, Considerations Before Commissioning, subsection 3-3-1 Initiating the Process- is being revised to describe the Alternative procedures for information sharing with state and local officials.
    • Section 3-3, Considerations Before Commissioning, subsection 3-3-2 Qualification; Eligibility- is being revised to include the following: "health, food or drug." Included statement: "FDA recommendations when an agency currently has or will have one or more officials that are commissioned by FDA, and Sharing Non-Public information under 21 CFR 20.88."
    • Section 3-3-3, Background Investigation- is being revised to include "health, food, or drug." Commissions with Certificates is being revised to include "background."
    • Section 3-3-4, Program Areas, Commissioning Activities- is being revised to include "health, food, or drug", and program areas "Bioterrorism, BSE Activity, Dairy, Interstate Travel Program, Methadone, Compressed Medical Gases, Pesticide Residue, and Tissue Residue."
    • Section 3-3-6, Contacting the Candidate, Eligible- is being revised to include the statement “If a candidate fails to return the required documentation to the regional commissioning contact within ninety (90) calendar days, the individual shall be considered as having withdrawn his or her candidacy. Commissioning packages received after ninety (90) calendar days will not be accepted or processed and subsequently the candidate will have to reapply.”
    • Section 3-4-3, Pocket Credentials, no pocket credentials- deleted paragraph, "State and local officials that FDA commissions under FDA's "streamlined" commissioning program for emergency purposed only. For additional information, contact DFSR."
    • Section 3-4-5, Privacy Act- is being revised to include Privacy Act.
    • Section 3-6-3, Sharing Non-public Information under 21 C.F.R. § 20.88 (State)- is being revised to describe sharing non-public information under 20.88 with state and local officials including those officials who are not commissioned.
    • Section 3-6-4, Sharing Non-public Information under 21 C.F.R. sec. 20.85 (Federal)- is being revised to include “FDA may share certain…”
    • Section 3-7-2 ,Background Investigation- is being revised to include “In addition to background investigations conducted prior to commissioning (See 3-3-3)), in…
    • Section 3-7-4, Renewal of Commission- is being changed to “three (3) months."
    • Section 3-7-5, Non-renewal of Commission- is being revised to include "outside of the organization" and includes the statement: " The regional commissioning contact will destroy the expired pocket credential in accordance with their regional procedures and will inform the Office of Partnerships when the destruction has been completed."
    • Section 3-7-6, Suspension of Commission- is being revised to address situations where commissioned State and local officials have been formally convicted of a crime.
    • Section 3-7-7, Revocation of Commission- is being revised to include “Conviction of a crime” for one of the reasons for revocation of commission, and the following statement: “The decision to revoke an FDA commission will be communicated in 30 calendar days to both the individual and his/her supervisor.” State or local officials- is being revised to describe the reporting procedures and its timeframes after violation for revocation has occurred.
    • Section 3-7-8, Relationship with Commissioned Officials- replaced broken link of the Annual Directory of State & Local Officials.
    • Section 3-8-1, RFDD Responsibilities- is being revised to include “one electronic (e.g., jpeg) color photograph of commission holder and optional-Form FDA 2081: Commissioned Officer’s Record (Exhibit 3-12). Paragraph #7 was changed to “three (3) months"
    • Section 3-8-2, Office of Partnerships- is being revised to include “Notify the Regions of individuals who fail to return the background investigation.
    • Section 3-10, Exhibits- deleted Exhibits 3-15 Model Agreement Format and 3-16 Model Addendum.
    • Exhibit 3-6, Model Letter Offering A Commission To An Agency Head- is being revised to include “name of state or territory)”.
    • Exhibit 3-8, Form: Basic Information From Candidate- is being revised to include the following statements: “I affirm that I am a United States citizen or United States National (describe below) and Describe qualification as United States National.”
    • Exhibit 3-10, Instructions to Candidate Photographs- is being revised to read, “If you are to be issued credentials, we need a color picture of your face, including the upper portion of your shoulders. The photo needs to be at a high resolution.
     
  • 02/04/2013: