74 FR 223 pgs. 60265-60276 - Agency Information Collection Activities; Proposed Collection; Comment Request; Records and Reports Concerning Experience With Approved New Animal Drugs; Proposed New Data Elements for Adverse Event Reports on Revised Forms FDA 1932 and 1932a
Type: NOTICEVolume: 74Number: 223Pages: 60265 - 60276
Docket number: [Docket No. FDA-2009-N-0556]
FR document: [FR Doc. E9-27956 Filed 11-19-09; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0556]
Agency Information Collection Activities; Proposed Collection; Comment Request; Records and Reports Concerning Experience With Approved New Animal Drugs; Proposed New Data Elements for Adverse Event Reports on Revised Forms FDA 1932 and 1932a
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow for public comment in response to the notice. This notice solicits comments on requirements for recordkeeping and reports concerning experience with approved new animal drugs, specifically on new data elements to be used in revised versions of Forms FDA 1932 and 1932a. The information contained in the reports required by this regulation enables FDA to monitor the use of new animal drugs after approval and to ensure their continued safety and efficacy.
DATES:
Submit written or electronic comments on the collection of information by December 21, 2009.
ADDRESSES:
Submit electronic comments on the collection of information to http://www.regulations.gov . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Office of Management Programs (HFA-710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-796-3793.
SUPPLEMENTARY INFORMATION:
I. Background
Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. "Collection of information" is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
II. Records and Reports Concerning Experience With Approved New Animal Drugs; Proposed New Data Elements for Adverse Event Reports on Revised Forms FDA 1932 and 1932a; 21 CFR 514.80 (OMB Control No. 0910-0645)-Revision
Section 512(l) of the Federal Food, Drug and Cosmetic Act (the act) (21 U.S.C. 360b(l)) and § 514.80(b) of FDA regulations (21 CFR 514.80) require applicants of approved new animal drug applications (NADAs) and approved abbreviated new animal drug applications (ANADAs) to report adverse drug experiences and product/manufacturing defects.
This continuous monitoring of approved NADAs and ANADAs affords the primary means by which FDA obtains information regarding potential problems with the safety and efficacy of marketed approved new animal drugs as well as potential product/manufacturing problems. Postapproval marketing surveillance is important because data previously submitted to FDA may no longer be adequate, as animal drug effects can change over time and less apparent effects may take years to manifest.
An applicant must report adverse drug experiences and product/manufacturing defects on Form FDA 1932, "Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report." Periodic drug experience reports and special drug experience reports must be accompanied by a completed Form FDA 2301, "Transmittal of Periodic Reports and Promotional Material for New Animal Drugs" (see § 514.80(d)). Form FDA 1932a, "Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect Report," allows for voluntary reporting of adverse drug experiences or product/manufacturing defects.
Collection of information using existing paper forms FDA 2301, 1932, and 1932a is currently approved under OMB control number 0910-0284, set to expire on January 31, 2010. FDA currently is seeking renewal of that information collection.
FDA recently proposed to collect information using electronic versions of Forms FDA 1932 and 1932a as part of the agency-wide information collection (MedWatchPlus Portal and Rational Questionnaire) that was announced for public comment in the Federal Register on October 23, 2008 (73 FR 63153). The MedWatchPlus Portal and Rational Questionnaire are components of a new electronic system for collecting, submitting, and processing adverse event reports and other safety information for all FDA-regulated products.
In this 30-day notice, FDA is requesting public comment on data elements associated with revisions to forms FDA 1932 and 1932a (both paper and electronic) under revised OMB control number 0910-0645, described below. We will publish separately in the Federal Register a 30-day notice to complete the renewal of OMB control number 0910-0284, the collection of information using existing paper forms FDA 2301, 1932, and 1932a, to provide time for development of the revised FDA Forms 1932 and 1932a and their incorporation into the MedWatch OMB control number 0910-0645. After these forms have been incorporated under MedWatch OMB control number 0910-0645, they will cease to exist under OMB control number 0910-0284. FDA Form 2301 will continue without revision under OMB control number 0910-0284.
This 30-day notice lists the data elements associated with revised versions of both paper and electronic forms 1932 and 1932a under a revision to OMB control number 0910-0645. It is estimated that, during the first 3 years that the MedWatchPlus Portal is in use, half of the reports will be submitted in paper format and half will be submitted electronically.
The reporting and recordkeeping burden estimates, including the total number of annual responses, are based on the submission of reports to the Division of Surveillance, Center for Veterinary Medicine. The hours per response for both paper and electronic versions of revised Forms FDA 1932 and 1932a are assumed to be the time it will take to gather the required information and complete each form. The annual frequency of responses was calculated as the total annual responses divided by the number of respondents.
FDA estimates the burden of this collection of information as follows:
| 21 CFR Section or Section of the Act | FDA Form No. | No. of Respondents | Annual Frequency per Response | Total Annual Responses | Hours per Response | Total Hours | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 514.80(b)(1), (b)(2)(i), (b)(2)(ii), and (b)(3); Paper Version | 19322 | 404 | 44.264 | 17,882.5 | 1.5 | 26,824 | |||||
| 514.80(b)(1), (b)(2)(i), (b)(2)(ii), and (b)(3); Electronic Version | 19322 , | 404 | 44.264 | 17,882.5 | 1 | 17,882.5 | |||||
| Voluntary reporting FDA Form 1932a for public; Paper Version | 1932a3 | 81.5 | 1 | 81.5 | 1 | 81.5 | |||||
| Voluntary reporting FDA Form 1932a for public; Electronic Version | 1932a3 | 81.5 | 1 | 81.5 | 0.6 | 48.9 | |||||
| Total Hours | 44,836.9 | ||||||||||
| 1 There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||||||||
| 2 FDA received 35,765 mandatory reports (Form FDA 1932) during 2007 from 808 respondents. Based on this experience, and taking into account the data element revisions, we estimate that CVM will receive 35,765 mandatory reports from 808 respondents annually. We estimate that one half of the respondents (404) will use the paper form, while the other half (404) will submit electronically; that is, we will receive 17,882.5 reports in paper form, and 17,882.5 reports electronically. We estimate the reporting burden for mandatory reporting to be: Paper form: 26,824 hours (404 respondents x 44.264 annual frequency of response x 1.5 hours ? 26,824 hours). Electronic form: 17,882.5 hours (404 respondents x 44.264 annual frequency of response x 1 hour ? 17,882.5 hours). | |||||||||||
| 3 FDA received 163 voluntary reports (Form FDA 1932a) during 2007. Based on this experience, and taking into account the data element revisions, we estimate that CVM will receive 163 voluntary reports from 163 respondents annually. We estimate that one half of the respondents (81.5) will use the paper form, while the other half (81.5) will submit electronically; that is, we will receive 81.5 reports in paper form, and 81.5 reports electronically. We estimate the reporting burden for voluntary reporting to be: Paper form: 81.5 hours (81.5 respondents x 1 annual frequency of response x 1 hour per report = 81.5 hours). Electronic form: 48.9 hours (81.5 respondents x 1 annual frequency of response x 0.6 hours per report = 48.9 hours). | |||||||||||
| 21 CFR Section | No. of Recordkeepers | Annual Frequency per Recordkeeping | Total Annual Records | Hours per Record | Total Hours |
|---|---|---|---|---|---|
| 514.80(e)2 | 90 | 55 | 4,949 | 0.5 | 2,4753 |
| 1 There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
| 2 Section 514.80(e) covers recordkeeping hours for adverse event reporting on revised forms 1932 and 1932a. | |||||
| 3 The annual frequency of responses was calculated as the total annual responses divided by the number of respondents. | |||||
III. Revisions to Forms FDA 1932 and 1932a and Request for Comments
A. Background on Revisions
Section 514.80(d) of FDA's regulations requires applicants of approved NADAs and ANADAs to report adverse drug experiences and product and manufacturing defects associated with their new animal drug products using Form FDA 1932. For voluntary reporting, Form FDA 1932a should be used instead.
As part of FDA's ongoing effort to harmonize the agency's adverse event (AE) regulatory reporting requirements with those of other nations and streamline reporting for product and manufacturing defects, FDA is contemplating changes to the data elements reported on Forms FDA 1932 and 1932a. Furthermore, the contemplated changes to Forms FDA 1932 and 1932a are based on FDA's experience in determining the safety and effectiveness of product(s) and need for efficient data capture and entry.
The contemplated changes to the AE reporting requirements for Form FDA 1932 are the product of discussions undertaken between the United States, Japan, and the European Union as part of the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). FDA is considering revisions to Form FDA 1932 that would bring the AE reporting data elements on the form more in line with the data elements developed as a result of the VICH discussions.1 The agency also is contemplating the inclusion of additional new data elements that would gather information specific only to FDA. Collecting this FDA-specific information is essential for the processing, review, and regulatory disposition of the electronic and paper reports. Inclusion of some of the new data elements is necessitated by the Rational Questionnaire.
Footnotes:
1 FDA will implement all of the VICH data elements verbatim from the draft guidance document entitled "Pharmacovigilance of Veterinary Medicinal Products Data Elements for Submission of Adverse Event Reports" (VICH GL-42), in Form FDA 1932. VICH GL-42 is currentlyunder discussion at Step 6. This guidance is available on the Internet at http://www.fda.gov/RegulatoryInformation/Guidances/default.htm .
In addition, the agency is considering adding new data elements for product and manufacturing defect reports on Form FDA 1932 and 1932a. These changes are the product of internal FDA discussions and are intended to capture additional pertinent product and manufacturing defect information.
B. Proposed Revisions
1. Form FDA 1932
This section describes data elements on the current Form FDA 1932, proposed new data elements, and data elements we propose to delete from the current form. These AE and product and manufacturing defect data elements will be collected electronically, through the MedWatchPlus Portal and Rational Questionnaire (currently under development), and in the paper form.
Table 3 of this document, entitled "Data Elements for Form FDA 1932," presents the data elements for the collection of animal drug adverse event reports and manufacturing and product defect reports. The data elements are listed in the column entitled "Data Elements." The column entitled "Current, New, or Deleted Data Element" indicates whether the data element is currently being collected (Current)2 , is a proposed new data element (New), or is a data element FDA proposes to delete (Deleted).
Footnotes:
2 In general, the information being collected is the same, but the data element has been renamed or restructured to facilitate data collection.
As previously mentioned in this document, the agency has had discussions with VICH regarding the data elements to be collected for animal drug adverse events. As a result, the agency is proposing new data elements that have been negotiated with VICH. The column entitled "VICH-Negotiated or FDA-Proposed Data Element" differentiates between VICH-negotiated and FDA-proposed data elements.
The agency intends to allow the regulated industry to submit this information collection in three different submission/transmission formats. Industry will be able to submit these reports using a paper form, the Web-based Rational Questionnaire, or an electronic file through the FDA electronic Gateway-to-Gateway transmission. The column entitled "Submission/Transmission Format" presents the submission/transmission format(s) that will be used with each particular data element.
| Line No. | Data Elements | Current, New, or Deleted Data Element | VICH-Negotiated or FDA-Proposed Data Element | Submission/Transmission Format (Paper Form, Electronic Web-based Rational Questionnaire (EWBRQ), and/or Electronic Gateway-to-Gateway (EGG)) |
|---|---|---|---|---|
| 1 | United States-Only Specific Information, including: | |||
| 2 | Report Identifier (The Report Identifier is the FDA application or file number of the AER being sent.) | Current | FDA Proposed | All Formats |
| 3 | Domestic vs. Foreign Category (This is a list of values describing whether the product is an FDA-approved product, a foreign-approved product, or other type of product, e.g., an unapproved drug.) | New | FDA Proposed | All Formats |
| 4 | United States Pharmacovigilance Contact Person for the Applicant or Nonapplicant (This is the person within the United States acting on behalf of the applicant or nonapplicant and is the contact person for the FDA for any pharmacovigilance issues about the report.), including: | |||
| 5 | Title, First and Last Name | Current | FDA Proposed | All Formats |
| 6 | Telephone Number, Fax Number, and E-Mail Address | New | FDA Proposed | All Formats |
| 7 | Message Sender Identifier (Name and contact information of person responsible for any corresponding communications regarding the whole batch electronic transmission.), including: | |||
| 8 | Street Address, City, State/County, and Mail/Zip Code | New | FDA Proposed | EGG Only |
| 9 | Three-character Country Code (This is the list of country codes from the International Organization for Standardization (ISO) 3166 standard.) | New | FDA Proposed | EGG Only |
| 10 | First and Last Name | New | FDA Proposed | EGG Only |
| 11 | Telephone Number, Fax Number, and E-Mail Address | New | FDA Proposed | EGG Only |
| 12 | Profile Identifier Code (This information indicates the type of report contained in the electronic message.) | New | FDA Proposed | EWBRQ and EGG Only |
| 13 | Batch ID (This information identifies the reports in this batch as a whole electronic message.) | New | FDA Proposed | EGG Only |
| 14 | Message Date (This information indicates the date this batch report is created.) | New | FDA Proposed | EGG Only |
| 15 | Message Version Number Release Number (This information indicates the Health Level Seven, Inc. (HL7) "Message Version" and "Release Number" on which this batch report electronic submission is based.) | New | FDA Proposed | EGG Only |
| 16 | Adverse Event Report (AER) Information, including: | |||
| 17 | Unique AER Identification Number (This globally unique AER identification number is created by and assigned by the applicant or nonapplicant.) | New | VICH Negotiated | All Formats |
| 18 | Original Receive Date (The original receive date is the date on which the first full communication of the AER was received by the applicant or nonapplicant responsible for reporting the AER to the FDA.) | Current | VICH Negotiated | All Formats |
| 19 | Date of Current Submission (This is the date the current AER was submitted to the Regulatory Authority (RA).) | Current | VICH Negotiated | All Formats |
| 20 | Type of Report, including: | |||
| 21 | Type of Submission (This is a list of values describing the regulatory type of report being submitted to the RA, e.g., 15-day NADA/ANADA alert report, 3-day NADA/ANADA field alert report, followup report, nullification report, periodic drug experience report, and other report.) | Current | VICH Negotiated | All Formats |
| 22 | Reason for Nullification Report (This is a text description of why this AER is being nullified.) | Current | VICH Negotiated | All Formats |
| 23 | Type of Information in Report (This is a list of values for the categorization of the type of information in the AER, e.g., spontaneous safety and lack of expected effectiveness information, clinical study safety information, product and manufacturing defect information, product and manufacturing defect with safety and lack of expected effectiveness information, and other type of information.) | New | VICH Negotiated | All Formats |
| 24 | Regulatory Authority (RA) Information (This is the RA to which this AE report (AER) is to be initially submitted based on the RA that has authority to regulate the product.), including: | |||
| 25 | RA Name | Current | VICH Negotiated | All Formats |
| 26 | Street Address, City, State/County, and Mail/Zip Code | Current | VICH Negotiated | All Formats |
| 27 | Three-character Country Code | Current | VICH Negotiated | All Formats |
| 28 | Marketing Authorization Holder (MAH) information. (The MAH is the applicant or the nonapplicant who is responsible for reporting the AER to the RA.), including: | |||
| 29 | Business Name | Current | VICH Negotiated | All Formats |
| 30 | Street Address, City, State/County, and Mail/Zip Code | Current | VICH Negotiated | All Formats |
| 31 | Three-character Country Code | Current | VICH Negotiated | All Formats |
| 32 | Person Acting on Behalf of the MAH information, including: | |||
| 33 | Title, First and Last Name | Current | VICH Negotiated | All Formats |
| 34 | Telephone Number, Fax Number, and E-Mail Address | New | VICH Negotiated | All Formats |
| 35 | Primary Reporter's information (The primary reporter is the person or organization, as determined by the MAH, which holds or provides the most pertinent information related to this AER.), including: | |||
| 36 | First and Last Name | Current | VICH Negotiated | All Formats |
| 37 | Telephone and Fax Number | Current | VICH Negotiated | All Formats |
| 38 | E-Mail Address | New | VICH Negotiated | All Formats |
| 39 | Business Name | Current | VICH Negotiated | All Formats |
| 40 | Street Address, City, State/County, and Mail/Zip Code | Current | VICH Negotiated | All Formats |
| 41 | Three-character Country Code | Current | VICH Negotiated | All Formats |
| 42 | Primary Reporter Category (This is a list of values describing the role/involvement of the primary reporter, e.g., animal owner, physician, et cetera.) | New | VICH Negotiated | All Formats |
| 43 | Other Reporter's information (The other reporter is the person or organization, determined by the MAH, who also possesses pertinent information related to this AER.), including: | |||
| 44 | First and Last Name | Current | VICH Negotiated | All Formats |
| 45 | Telephone and Fax Number | Current | VICH Negotiated | All Formats |
| 46 | E-Mail Address | New | VICH Negotiated | All Formats |
| 47 | Business Name | Current | VICH Negotiated | All Formats |
| 48 | Street Address, City, State/County, and Mail/Zip Code | Current | VICH Negotiated | All Formats |
| 49 | Three-character Country Code | Current | VICH Negotiated | All Formats |
| 50 | Other Reporter Category (This is a list of values describing the role/involvement of the other reporter, e.g., animal owner, physician, et cetera.) | New | VICH Negotiated | All Formats |
| 51 | Veterinary Medical Product (VMP) and Data Usage (for all VMPs), including: | |||
| 52 | Registered or Brand Name (This is the name by which the product is presented by the MAH, also known as the Proprietary Name or Trade Name of the product.) | Current | VICH Negotiated | All Formats |
| 53 | Product Code (The product code is the National Drug Code (NDC) number for U.S. FDA-regulated products.) | New | VICH Negotiated | All Formats |
| 54 | Registration Identifier (The Registration Identifier is the code for where the VMP is approved, what RA is responsible for regulating VMP, and the registration number of the VMP.) | VICH Negotiated | All Formats | |
| 55 | ATCvet Code (ATCvet stands for Anatomic Therapeutic Chemical System for Veterinary Medicine. It is used for the classification of substances intended for therapeutic use and can serve as a tool for the classification of veterinary medicinal products. More information about the ATCvet code is available at http://www.whocc.no/atcvet/ ) | New | VICH Negotiated | All Formats |
| 56 | Who Administered the VMP (This is a list of values describing the person who administered the VMP(s) to the animal involved in the AE, e.g., veterinarian, animal owner, et cetera.) | Current | VICH Negotiated | All Formats |
| 57 | Company or MAH (This is the name(s) of the company or MAH that owns the VMP(s) involved in the AE.) | Current | VICH Negotiated | All Formats |
| 58 | MAH Assessment (This is the assessment by the MAH of the association between the use of the VMP and the AE.) | Current | VICH Negotiated | All Formats |
| 59 | FDA, Office of Regulatory Affairs (ORA) District Field Office (This is a list of values identifying the ORA District Field Office or local FDA residence post to which the product and manufacturing defect information was submitted. This field is used for product and manufacturing defect reports and if the report is both an AE and a product and manufacturing defect report.) | New | FDA Proposed | All Formats |
| 60 | Use According to Label (This element requests information regarding whether the VMP(s) was used according to its label.) | Current | VICH Negotiated | All Formats |
| 61 | Explanation for Off-Label Use Code (This is the list of values describing how the VMP was used in an off-label (extralabel) manner.) | New | VICH Negotiated | All Formats |
| 62 | Active Ingredient information, including: | |||
| 63 | Active Ingredient(s) (These are the names of the pharmaceutical substances that comprise the active component of the VMP.) | Current | VICH Negotiated | All Formats |
| 64 | Strength and Strength Unit (Numerator and Denominator) (Strength is the concentration of the active ingredient.) | Current | VICH Negotiated | All Formats |
| 65 | Active Ingredient Code (The active ingredient code is the Unique Ingredient Identifier (UNII) code. The UNII code is generated by the joint FDA/United States Pharmacopeia (USP) Substance Registration System (SRS).) | New | VICH Negotiated | All Formats |
| 66 | Dosage Form (This is a selection for a list of values for the labeled dosage form of the VMP(s).) | Current | VICH Negotiated | All Formats |
| 67 | Dosing Information, including: | |||
| 68 | Date of First Exposure (Day, Month, Year) (This is the date on which the animal was first treated with the VMP.) | Current | VICH Negotiated | All Formats |
| 69 | Date of Last Exposure (Day, Month, Year) (This is the date on which the animal was last treated with the VMP.) | Current | VICH Negotiated | All Formats |
| 70 | Numeric Value and Unit for Interval of Administration (This is the frequency of administration of the VMP(s).) | Current | VICH Negotiated | All Formats |
| 71 | Numeric Value and Unit for Dose (This is the actual quantity of the dose administered.) | Current | VICH Negotiated | All Formats |
| 72 | Route of Exposure (This is a selection from a list of values for the route by which the VMP was administered.) | Current | VICH Negotiated | All Formats |
| 73 | Lot Number Information, including: | |||
| 74 | Lot Number (This is the lot number associated with the VMP in this AER.) | Current | VICH Negotiated | All Formats |
| 75 | Expiration Date (Day, Month, Year) (This is the expiration date associated with the lot number.) | New | VICH Negotiated | All Formats |
| 76 | Manufacturing Site Identifier Number (This is the FDA Establishment Number (FEI Number) or the Data Universal Number System (D-U-N-S® Number.) | New | FDA Proposed | All Formats |
| 77 | Manufacturer's Identifier Type (This is a list of values describing the type of manufacturing site identifier number, i.e., FEI Number or D-U-N-S® Number.) | New | FDA Proposed | All Formats |
| 78 | Manufacturing Date (Day, Month, Year) (This is the date the VMP was manufactured.) | New | FDA Proposed | All Formats |
| 79 | Number of Defective Units (This is the number of defective units associated with this VMP.) | New | FDA Proposed | All Formats |
| 80 | Number of Units Returned (This is the number of defective units associated with this VMP returned to the applicant or nonapplicant.) | New | FDA Proposed | All Formats |
| 81 | Adverse Event Information, including: | |||
| 82 | Attending Veterinarian's Assessment (This is a list of values describing the assessment of the attending veterinarian regarding the association between the VMP(s) and the AE (other than human).) | Current | VICH Negotiated | All Formats |
| 83 | Previous Exposure to the VMP (Was the animal previously exposed to the VMP(s)?) | Current | VICH Negotiated | All Formats |
| 84 | Previous AE to the VMP (Did the animal have a previous AE to the VMP(s)?) | Current | VICH Negotiated | All Formats |
| 85 | Duration and Time Units (This is the length of time the AE lasted.) | Current | VICH Negotiated | All Formats |
| 86 | Serious AE (Was the AE serious?) | Current | VICH Negotiated | All Formats |
| 87 | Treatment of AE (Was the AE treated?) | Current | VICH Negotiated | All Formats |
| 88 | Outcome to Date, including: (number of) | |||
| 89 | Recovered/Normal, Ongoing, Recovered with Sequela, and Unknown | Current | VICH Negotiated | All Formats |
| 90 | Euthanized | New | VICH Negotiated | All Formats |
| 91 | Died | Current | VICH Negotiated | All Formats |
| 92 | Length of Time Between Exposure to VMP(s) and Onset of AE (This is a list of values describing the length of time between the first exposure to the VMP and the onset of the AE.) | Current | VICH Negotiated | All Formats |
| 93 | Date of Onset of AE (Day, Month, Year) (This is the date of the first clinical manifestation of the AE.) | Current | VICH Negotiated | All Formats |
| 94 | Adverse Clinical Manifestations (This is a list of values describing the clinical signs that occurred during the AE.) | Current | VICH Negotiated | All Formats |
| 95 | Narrative of AE (open text field) (This is a detailed description of the case, regardless of the type of information contained in the report.) | Current | VICH Negotiated | All Formats |
| 96 | Did the AE Abate After Stopping the VMP? | Current | VICH Negotiated | All Formats |
| 97 | Did the AE Reappear After Re-Introduction of the VMP? | Current | VICH Negotiated | All Formats |
| 98 | Animal Data, including: | |||
| 99 | Species (This is a list of values describing the species of the animal(s) involved in the AER.) | Current | VICH Negotiated | All Formats |
| 100 | Breeds and Crossbreed Information (This is a list of values describing the breed(s) of animal(s) involved in the AER.) | Current | VICH Negotiated | All Formats |
| 101 | Gender (This is a list of values for the selection of the gender(s) of animal(s) involved in the AER.) | Current | VICH Negotiated | All Formats |
| 102 | Reproductive Status (This is a list of values describing if the animal is intact, neutered, etc.) | Current | VICH Negotiated | All Formats |
| 103 | Female Physiological Status. (This is a list of values describing the animal's pregnancy and lactation status.) | Current | VICH Negotiated | All Formats |
| 104 | Age (Measured, Estimated, Unknown), including: | |||
| 105 | Precision Value for Age (Measured, Estimated, Unknown Age. This is a list of values describing whether the age(s) provided are measured or estimated, or if age is not known.) | New | VICH Negotiated | All Formats |
| 106 | Minimum Age Value and Units. | Current | VICH Negotiated | All Formats |
| 107 | Maximum Age Value and Units. | Current | VICH Negotiated | All Formats |
| 108 | Weight, including: | |||
| 109 | Precision Value for Weight (Measured, Estimated, Unknown Weights) (This is a list of values describing whether the weight(s) provided are measured or estimated, or if weight is not known.) | New | VICH Negotiated | All Formats |
| 110 | Minimum Weight | Current | VICH Negotiated | All Formats |
| 111 | Maximum Weight | Current | VICH Negotiated | All Formats |
| 112 | Attending Veterinarian's Assessment of Animal Health Status Prior to VMP. (This is a list of values describing the attending veterinarian's assessment of the health status of the animal(s) involved in the AE prior to their exposure to the VMP.) | Current | VICH Negotiated | All Formats |
| 113 | Number of Animals Treated (This is the number of animal(s) being directly treated by the VMP(s).) | Current | VICH Negotiated | All Formats |
| 114 | Number of Animals Affected (This is the total number of animals affected in the AER, whether by direct or indirect exposure.) | Current | VICH Negotiated | All Formats |
| 115 | Supplemental Documents, including: | |||
| 116 | Attached Document (These are additional documents containing information relevant to the AE, such as medical record, radiology, clinical chemistry reports, newspaper articles, and letters.) | Current | VICH Negotiated | All Formats |
| 117 | Attached Document Filename (This is the name of the document for paper documents or the electronic file for electronic transmissions.) | Current | VICH Negotiated | All Formats |
| 118 | Attached Document Type (This is a list of values describing the type of document that is attached, e.g., necropsy report) | Current | VICH Negotiated | All Formats |
| 119 | The following data elements are being deleted from the information collection: | |||
| 120 | 2c. Number of Days Between 2a and b: | Deleted | ||
| 121 | 11. Illness/reason for use of this drug | Deleted | ||
| 122 | 17. Did any new illness develop or did initial diagnosis change after suspect drug started? | Deleted | ||
| 123 | 25. Outcome of Reaction to Date - Died | Deleted | ||
| 124 | 26. When reaction appeared, treatment with suspect drug: has already been completed, discontinued, replaced with another drug; continued at altered dose, other (explain)-and the reaction: continued, stopped, recurred, or other (explain) | Deleted | ||
| 125 | 29. Had animal(s) previously reacted to other drugs? | Deleted | ||
| 126 | 30. Has the attending veterinarian seen similar reactions to this drug in any other animals? | Deleted | ||
| 127 | 32. Signature of individual responsible for accuracy of reported information | Deleted |
2. Form FDA 1932a
This section describes data elements on the current Form FDA 1932a and the proposed new data elements. These AE and product and manufacturing defect data elements will be collected electronically, through the MedWatchPlus Portal Rational Questionnaire, and in the paper form. All the data elements will be captured using the MedWatchPlus Portal Rational Questionnaire or the paper form.
Table 4 of this document, entitled "Data Element Information Collection for Form FDA 1932a," presents the data elements the agency is proposing for the collection of animal drug adverse events reports and manufacturing and product problem reports for individuals who choose to report information voluntarily to FDA. The current and proposed new data elements are listed in the column entitled "Data Elements." In general, the information being collected is the same, but the data element has been renamed or restructured to facilitate data collection. As stated previously in this document, the proposed changes are based on FDA's experience in determining the safety and effectiveness of product(s) and need for efficient data capture and entry.
| Line No. | Data Elements | Current or New Data Element |
|---|---|---|
| 1 | Individual Case Safety Report Number (FDA-Assigned Number) | New |
| 2 | Date of Initial Report. (This is the date the sender sent the first report of the information.) | New |
| 3 | Date Reported (This is the date of this current report.) | Current |
| 4 | Submission Type (This is a list of values describing the type of submission, e.g., Initial or Followup Report) | New |
| 5 | Report Type (This is a list of values describing the type of information in the report, e.g., adverse event, product problem, or both) | New |
| 6 | Manufacturer's Case Number. (The manufacturer's case number is given to the sender by the manufacturer of the product if the sender contacted the manufacturer.) | Current |
| 7 | Sender Information (The sender is the person or organization which fills out the report and submits or transmits the report to FDA.), including: | |
| 8 | Sender First and Last Name | New |
| 9 | Sender Street Address, City, State/Province, Postal/Zip Code, and Country | New |
| 10 | Sender Primary and Other Telephone Number, E-Mail Address, and Fax Number | New |
| 11 | Sender Category. (This is a list of values describing the role/involvement of the sender, e.g., animal owner, physician, etc.) | New |
| 12 | Did the sender report to other sources? | New |
| 13 | Sender also reported to other sources. (This is a list of values describing the sources to which the sender reported the AE or product problem, e.g., manufacturer, distributor, etc.) | New |
| 14 | No identity disclosure (This data element indicates whether the sender wants their identity disclosed to the manufacturer.) | Current |
| 15 | Preferred Method of Contact. (This is a list of values describing the preferred method of contacting the sender, e.g., telephone, e-mail.) | New |
| 16 | Healthcare Professional Information, including: | |
| 17 | Healthcare Professional First and Last Name. | Current |
| 18 | Healthcare Professional Street Address, City, State/Province, and Postal/Zip Code | Current |
| 19 | Healthcare Professional Primary and Other Phone Number | Current |
| 20 | Healthcare Professional e-mail address | New |
| 21 | Healthcare Professional Country | New |
| 22 | Owner's Information (This is the owner of the animal involved in the case.), including: | |
| 23 | Owner First and Last Name. | Current |
| 24 | Owner Primary and Other Phone Number, and E-Mail Address | New |
| 25 | Owner Street Address, City, State/Province, Postal/Zip Code, and Country | New |
| 26 | Product Information: | |
| 27 | Name of Suspected Product. (This is the name of the product suspected of causing the AE or the product with the product problem.) | Current |
| 28 | Name of Manufacturer | Current |
| 29 | Lot Number | Current |
| 30 | Expiration Date | Current |
| 31 | Diagnosis and/or Reason for Use of the Product | Current |
| 32 | Product Use Information: Dose Administered (amount of product administered), Interval of Administration (frequency of administration-every 12 hours or for 5 days), and Route of Administration (oral, injection, topical, etc.). | Current |
| 33 | Dosage Form. (This is how the product was supplied to the animal, e.g., chewable tablet, topical, injection) | Current |
| 34 | Date of First and Last Exposure. (This is the date the product(s) was first administered and last administered to the animal.) | Current |
| 35 | Duration of Product Use (Number) and Units of Measurement. (This is the duration the product was given, e.g., 2 weeks.) | New |
| 36 | Product Administered By (This is a list of values describing who administered the product(s), e.g., veterinarian/veterinary staff, Owner) | Current |
| 37 | Concurrent Drugs Administered (Were concurrent product(s) given to the animal(s)?) | Current |
| 38 | Concurrent Products Names. (This is the name of all concurrent products involved in the case.) | Current |
| 39 | Animal Information: | |
| 40 | Species. (This is a list of values for selecting the species of the animal(s) involved in the case.) | Current |
| 41 | Breed and Crossbreed (This is the breed(s) of animal(s) involved in the report.) | Current |
| 42 | Gender. (This a list of values for the selection of the gender(s) of animal(s) involved in the AER.) | Current |
| 43 | Reproductive Status. (This is a list of values describing whether the animal is intact, neutered, et cetera.) | Current |
| 44 | Age and Age Units | Current |
| 45 | Weight and Weight Units | Current |
| 46 | Overall Health Status When Suspected Product Given. (This is a list of values describing the health status of the animal(s) involved in the AE prior to their exposure to the product(s).) | Current |
| 47 | Number of Animals Treated (This is the number of animal(s) being directly treated by the product(s).) | New |
| 48 | Number of Animals Affected. (This is the total number of animals affected in the AER, whether by direct or indirect exposure.) | New |
| 49 | Adverse Event Information: | |
| 50 | Veterinarian's Level of Suspicion that Product Caused the AE. (This is a list of values describing the veterinarian's level of suspicion, e.g., high, medium, low, or unknown.) | Current |
| 51 | Treatment of AE. (This is a description of how the AE was treated.) | Current |
| 52 | Did the AE Abate After Stopping the Product? | Current |
| 53 | Did the AE Reappear After Reintroduction of the product? | Current |
| 54 | Outcome. (This is a list of values describing the overall animal health status after exposure to the product.) | Current |
| 55 | Length of Time Between Initial Exposure to Suspected Product and Onset of AE, numeric value and units of measurement | Current |
| 56 | Length of Time Between Last Administration of Suspected Product and Onset of AE, numeric value and units of measurement | Current |
| 57 | Date of Onset of AE. (This is the date that the first adverse clinical sign(s) occurred.) | New |
| 58 | Date of Product Problem Discovery. (This is the date that the product problem was discovered.) | New |
| 59 | When the AE Occurred, Treatment with Suspected Product. (This is a list of values describing the use of the suspected product after the AE occurred) | Current |
| 60 | Other Relevant Clinical Information: | |
| 61 | Concurrent Clinical Problem (Does the animal(s) have concurrent clinical problems?) | Current |
| 62 | List Concurrent Clinical Problem(s) | Current |
| 63 | AE/Product Problem (Long Narrative) (This is a detailed description of the case.) | Current |
| 64 | Supplemental Documents: | |
| 65 | Attached Document Name/File name (if electronic) (This is the name of the document for paper documents or the name of the electronic file for electronic transmissions.) | Current |
| 66 | Attached Document Type (This is a list of values describing the type of document that is attached, e.g., necropsy report) | Current |
| 67 | Attached Document(s) (These are additional documents containing information relevant to the AE, e.g., medical record, radiology, clinical chemistry reports, newspaper articles, and letters.) | Current |
| 68 | Attached Document Description. (This is a description of the document.) | New |
C. Request for Comments
FDA invites comments on all aspects of the revised collection of the data elements for Forms FDA 1932 and 1932a as set forth in section III.B of this notice, including whether such lists incorporate all data elements necessary to report an adverse event and a product or manufacturing defect, and whether certain data elements should be deleted or modified. Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) electronic or written comments regarding the proposed changes. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: November 16, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-27956 Filed 11-19-09; 8:45 am]
BILLING CODE 4160-01-S