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, 60265-60276 [E9-27956]
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[Federal Register Volume 74, Number 223 (Friday, November 20, 2009)] [Notices] [Pages 60265-60276] From the Federal Register Online via the Government Printing Office [www.gpo.gov] [FR Doc No: E9-27956] ----------------------------------------------------------------------- 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 https://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 Sec. 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 Sec. 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 (MedWatch\Plus\ Portal and Rational Questionnaire) that was announced for public comment in the Federal Register on October 23, 2008 (73 FR 63153). The MedWatch\Plus\ 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 [[Page 60266]] 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 MedWatch\Plus\ 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: Table 1.--Estimated Annual Reporting Burden\1\ ---------------------------------------------------------------------------------------------------------------- 21 CFR Section or Section of FDA Form No. No. of Annual Frequency Total Annual Hours per Total Hours the Act Respondents per Response Responses Response ---------------------------------------------------------------------------------------------------------------- 514.80(b)(1), 1932\2\ 404 44.264 17,882.5 1.5 26,824 (b)(2)(i), (b)(2)(ii), and (b)(3); Paper Version ---------------------------------------------------------------------------------------------------------------- 514.80(b)(1), 1932\2\, 404 44.264 17,882.5 1 17,882.5 (b)(2)(i), (b)(2)(ii), and (b)(3); Electronic Version ---------------------------------------------------------------------------------------------------------------- Voluntary 1932a\3\ 81.5 1 81.5 1 81.5 reporting FDA Form 1932a for public; Paper Version ---------------------------------------------------------------------------------------------------------------- Voluntary 1932a\3\ 81.5 1 81.5 0.6 48.9 reporting FDA Form 1932a for public; Electronic Version ---------------------------------------------------------------------------------------------------------------- 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 [ap] 26,824 hours). Electronic form: 17,882.5 hours (404 respondents x 44.264 annual frequency of response x 1 hour [ap] 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). Table 2.--Estimated Annual Recordkeeping Burden\1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- No. of Annual Frequency Total Annual 21 CFR Section Recordkeepers per Recordkeeping Records Hours per Record Total Hours -------------------------------------------------------------------------------------------------------------------------------------------------------- 514.80(e)\2\ 90 55 4,949 0.5 2,475\3\ -------------------------------------------------------------------------------------------------------------------------------------------------------- \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 [[Page 60267]] 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. --------------------------------------------------------------------------- \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 currently under discussion at Step 6. This guidance is available on the Internet at https://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 MedWatch\Plus\ 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). --------------------------------------------------------------------------- \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. Table 3.--Data Elements for Form FDA 1932 ---------------------------------------------------------------------------------------------------------------- Submission/ Transmission Format (Paper Form, Current, New, or VICH-Negotiated Electronic Web- Line No. Data Elements Deleted Data or FDA-Proposed based Rational Element Data Element Questionnaire (EWBRQ), and/or Electronic Gateway- to-Gateway (EGG)) ---------------------------------------------------------------------------------------------------------------- 1 United States-Only Specific Information, including: ---------------------------------------------------------------------------------------------------------------- 2 Report Identifier (The Report Identifier Current FDA Proposed All Formats is the FDA application or file number of the AER being sent.) ---------------------------------------------------------------------------------------------------------------- 3 Domestic vs. Foreign Category (This is a New FDA Proposed All Formats 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.) ---------------------------------------------------------------------------------------------------------------- 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 New FDA Proposed All Formats Address ---------------------------------------------------------------------------------------------------------------- 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 New FDA Proposed EGG Only Mail/Zip Code ---------------------------------------------------------------------------------------------------------------- 9 Three-character Country Code (This is New FDA Proposed EGG Only the list of country codes from the International Organization for Standardization (ISO) 3166 standard.) ---------------------------------------------------------------------------------------------------------------- 10 First and Last Name New FDA Proposed EGG Only ---------------------------------------------------------------------------------------------------------------- 11 Telephone Number, Fax Number, and E-Mail New FDA Proposed EGG Only Address ---------------------------------------------------------------------------------------------------------------- 12 Profile Identifier Code (This New FDA Proposed EWBRQ and EGG Only information indicates the type of report contained in the electronic message.) ---------------------------------------------------------------------------------------------------------------- [[Page 60268]] 13 Batch ID (This information identifies New FDA Proposed EGG Only the reports in this batch as a whole electronic message.) ---------------------------------------------------------------------------------------------------------------- 14 Message Date (This information indicates New FDA Proposed EGG Only the date this batch report is created.) ---------------------------------------------------------------------------------------------------------------- 15 Message Version Number & Release Number New FDA Proposed EGG Only (This information indicates the Health Level Seven, Inc. (HL7) ``Message Version'' and ``Release Number'' on which this batch report electronic submission is based.) ---------------------------------------------------------------------------------------------------------------- 16 Adverse Event Report (AER) Information, including: ---------------------------------------------------------------------------------------------------------------- 17 Unique AER Identification Number (This New VICH Negotiated All Formats globally unique AER identification number is created by and assigned by the applicant or nonapplicant.) ---------------------------------------------------------------------------------------------------------------- 18 Original Receive Date (The original Current VICH Negotiated All Formats 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.) ---------------------------------------------------------------------------------------------------------------- 19 Date of Current Submission (This is the Current VICH Negotiated All Formats date the current AER was submitted to the Regulatory Authority (RA).) ---------------------------------------------------------------------------------------------------------------- 20 Type of Report, including: ---------------------------------------------------------------------------------------------------------------- 21 Type of Submission (This is a list of Current VICH Negotiated All Formats 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.) ---------------------------------------------------------------------------------------------------------------- 22 Reason for Nullification Report (This is Current VICH Negotiated All Formats a text description of why this AER is being nullified.) ---------------------------------------------------------------------------------------------------------------- 23 Type of Information in Report (This is a New VICH Negotiated All Formats 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.) ---------------------------------------------------------------------------------------------------------------- 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 Current VICH Negotiated All Formats Mail/Zip Code ---------------------------------------------------------------------------------------------------------------- 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 Current VICH Negotiated All Formats Mail/Zip Code ---------------------------------------------------------------------------------------------------------------- 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 ---------------------------------------------------------------------------------------------------------------- [[Page 60269]] 34 Telephone Number, Fax Number, and E-Mail New VICH Negotiated All Formats Address ---------------------------------------------------------------------------------------------------------------- 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 Current VICH Negotiated All Formats Mail/Zip Code ---------------------------------------------------------------------------------------------------------------- 41 Three-character Country Code Current VICH Negotiated All Formats ---------------------------------------------------------------------------------------------------------------- 42 Primary Reporter Category (This is a New VICH Negotiated All Formats list of values describing the role/ involvement of the primary reporter, e.g., animal owner, physician, et cetera.) ---------------------------------------------------------------------------------------------------------------- 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 Current VICH Negotiated All Formats Mail/Zip Code ---------------------------------------------------------------------------------------------------------------- 49 Three-character Country Code Current VICH Negotiated All Formats ---------------------------------------------------------------------------------------------------------------- 50 Other Reporter Category (This is a list New VICH Negotiated All Formats of values describing the role/ involvement of the other reporter, e.g., animal owner, physician, et cetera.) ---------------------------------------------------------------------------------------------------------------- 51 Veterinary Medical Product (VMP) and Data Usage (for all VMPs), including: ---------------------------------------------------------------------------------------------------------------- 52 Registered or Brand Name (This is the Current VICH Negotiated All Formats name by which the product is presented by the MAH, also known as the Proprietary Name or Trade Name of the product.) ---------------------------------------------------------------------------------------------------------------- 53 Product Code (The product code is the New VICH Negotiated All Formats National Drug Code (NDC) number for U.S. FDA-regulated products.) ---------------------------------------------------------------------------------------------------------------- 54 Registration Identifier (The ................. VICH Negotiated All Formats 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.) ---------------------------------------------------------------------------------------------------------------- 55 ATCvet Code (ATCvet stands for Anatomic New VICH Negotiated All Formats 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 https://www.whocc.no/atcvet/ ) ---------------------------------------------------------------------------------------------------------------- 56 Who Administered the VMP (This is a list Current VICH Negotiated All Formats of values describing the person who administered the VMP(s) to the animal involved in the AE, e.g., veterinarian, animal owner, et cetera.) ---------------------------------------------------------------------------------------------------------------- [[Page 60270]] 57 Company or MAH (This is the name(s) of Current VICH Negotiated All Formats the company or MAH that owns the VMP(s) involved in the AE.) ---------------------------------------------------------------------------------------------------------------- 58 MAH Assessment (This is the assessment Current VICH Negotiated All Formats by the MAH of the association between the use of the VMP and the AE.) ---------------------------------------------------------------------------------------------------------------- 59 FDA, Office of Regulatory Affairs (ORA) New FDA Proposed All Formats 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.) ---------------------------------------------------------------------------------------------------------------- 60 Use According to Label (This element Current VICH Negotiated All Formats requests information regarding whether the VMP(s) was used according to its label.) ---------------------------------------------------------------------------------------------------------------- 61 Explanation for Off-Label Use Code (This New VICH Negotiated All Formats is the list of values describing how the VMP was used in an off-label (extralabel) manner.) ---------------------------------------------------------------------------------------------------------------- 62 Active Ingredient information, including: ---------------------------------------------------------------------------------------------------------------- 63 Active Ingredient(s) (These are the Current VICH Negotiated All Formats names of the pharmaceutical substances that comprise the active component of the VMP.) ---------------------------------------------------------------------------------------------------------------- 64 Strength and Strength Unit (Numerator Current VICH Negotiated All Formats and Denominator) (Strength is the concentration of the active ingredient.) ---------------------------------------------------------------------------------------------------------------- 65 Active Ingredient Code (The active New VICH Negotiated All Formats 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).) ---------------------------------------------------------------------------------------------------------------- 66 Dosage Form (This is a selection for a Current VICH Negotiated All Formats list of values for the labeled dosage form of the VMP(s).) ---------------------------------------------------------------------------------------------------------------- 67 Dosing Information, including: ---------------------------------------------------------------------------------------------------------------- 68 Date of First Exposure (Day, Month, Current VICH Negotiated All Formats Year) (This is the date on which the animal was first treated with the VMP.) ---------------------------------------------------------------------------------------------------------------- 69 Date of Last Exposure (Day, Month, Year) Current VICH Negotiated All Formats (This is the date on which the animal was last treated with the VMP.) ---------------------------------------------------------------------------------------------------------------- 70 Numeric Value and Unit for Interval of Current VICH Negotiated All Formats Administration (This is the frequency of administration of the VMP(s).) ---------------------------------------------------------------------------------------------------------------- 71 Numeric Value and Unit for Dose (This is Current VICH Negotiated All Formats the actual quantity of the dose administered.) ---------------------------------------------------------------------------------------------------------------- 72 Route of Exposure (This is a selection Current VICH Negotiated All Formats from a list of values for the route by which the VMP was administered.) ---------------------------------------------------------------------------------------------------------------- 73 Lot Number Information, including: ---------------------------------------------------------------------------------------------------------------- 74 Lot Number (This is the lot number Current VICH Negotiated All Formats associated with the VMP in this AER.) ---------------------------------------------------------------------------------------------------------------- 75 Expiration Date (Day, Month, Year) (This New VICH Negotiated All Formats is the expiration date associated with the lot number.) ---------------------------------------------------------------------------------------------------------------- 76 Manufacturing Site Identifier Number New FDA Proposed All Formats (This is the FDA Establishment Number (FEI Number) or the Data Universal Number System (D-U-N-S[reg] Number.) ---------------------------------------------------------------------------------------------------------------- [[Page 60271]] 77 Manufacturer's Identifier Type (This is New FDA Proposed All Formats a list of values describing the type of manufacturing site identifier number, i.e., FEI Number or D-U-N-S[reg] Number.) ---------------------------------------------------------------------------------------------------------------- 78 Manufacturing Date (Day, Month, Year) New FDA Proposed All Formats (This is the date the VMP was manufactured.) ---------------------------------------------------------------------------------------------------------------- 79 Number of Defective Units (This is the New FDA Proposed All Formats number of defective units associated with this VMP.) ---------------------------------------------------------------------------------------------------------------- 80 Number of Units Returned (This is the New FDA Proposed All Formats number of defective units associated with this VMP returned to the applicant or nonapplicant.) ---------------------------------------------------------------------------------------------------------------- 81 Adverse Event Information, including: ---------------------------------------------------------------------------------------------------------------- 82 Attending Veterinarian's Assessment Current VICH Negotiated All Formats (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).) ---------------------------------------------------------------------------------------------------------------- 83 Previous Exposure to the VMP (Was the Current VICH Negotiated All Formats animal previously exposed to the VMP(s)?) ---------------------------------------------------------------------------------------------------------------- 84 Previous AE to the VMP (Did the animal Current VICH Negotiated All Formats have a previous AE to the VMP(s)?) ---------------------------------------------------------------------------------------------------------------- 85 Duration and Time Units (This is the Current VICH Negotiated All Formats length of time the AE lasted.) ---------------------------------------------------------------------------------------------------------------- 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 Current VICH Negotiated All Formats with Sequela, and Unknown ---------------------------------------------------------------------------------------------------------------- 90 Euthanized New VICH Negotiated All Formats ---------------------------------------------------------------------------------------------------------------- 91 Died Current VICH Negotiated All Formats ---------------------------------------------------------------------------------------------------------------- 92 Length of Time Between Exposure to Current VICH Negotiated All Formats 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.) ---------------------------------------------------------------------------------------------------------------- 93 Date of Onset of AE (Day, Month, Year) Current VICH Negotiated All Formats (This is the date of the first clinical manifestation of the AE.) ---------------------------------------------------------------------------------------------------------------- 94 Adverse Clinical Manifestations (This is Current VICH Negotiated All Formats a list of values describing the clinical signs that occurred during the AE.) ---------------------------------------------------------------------------------------------------------------- 95 Narrative of AE (open text field) (This Current VICH Negotiated All Formats is a detailed description of the case, regardless of the type of information contained in the report.) ---------------------------------------------------------------------------------------------------------------- 96 Did the AE Abate After Stopping the Current VICH Negotiated All Formats VMP? ---------------------------------------------------------------------------------------------------------------- 97 Did the AE Reappear After Re- Current VICH Negotiated All Formats Introduction of the VMP? ---------------------------------------------------------------------------------------------------------------- 98 Animal Data, including: ---------------------------------------------------------------------------------------------------------------- 99 Species (This is a list of values Current VICH Negotiated All Formats describing the species of the animal(s) involved in the AER.) ---------------------------------------------------------------------------------------------------------------- [[Page 60272]] 100 Breeds and Crossbreed Information (This Current VICH Negotiated All Formats is a list of values describing the breed(s) of animal(s) involved in the AER.) ---------------------------------------------------------------------------------------------------------------- 101 Gender (This is a list of values for the Current VICH Negotiated All Formats selection of the gender(s) of animal(s) involved in the AER.) ---------------------------------------------------------------------------------------------------------------- 102 Reproductive Status (This is a list of Current VICH Negotiated All Formats values describing if the animal is intact, neutered, etc.) ---------------------------------------------------------------------------------------------------------------- 103 Female Physiological Status. (This is a Current VICH Negotiated All Formats list of values describing the animal's pregnancy and lactation status.) ---------------------------------------------------------------------------------------------------------------- 104 Age (Measured, Estimated, Unknown), including: ---------------------------------------------------------------------------------------------------------------- 105 Precision Value for Age (Measured, New VICH Negotiated All Formats 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.) ---------------------------------------------------------------------------------------------------------------- 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, New VICH Negotiated All Formats 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.) ---------------------------------------------------------------------------------------------------------------- 110 Minimum Weight Current VICH Negotiated All Formats ---------------------------------------------------------------------------------------------------------------- 111 Maximum Weight Current VICH Negotiated All Formats ---------------------------------------------------------------------------------------------------------------- 112 Attending Veterinarian's Assessment of Current VICH Negotiated All Formats 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.) ---------------------------------------------------------------------------------------------------------------- 113 Number of Animals Treated (This is the Current VICH Negotiated All Formats number of animal(s) being directly treated by the VMP(s).) ---------------------------------------------------------------------------------------------------------------- 114 Number of Animals Affected (This is the Current VICH Negotiated All Formats total number of animals affected in the AER, whether by direct or indirect exposure.) ---------------------------------------------------------------------------------------------------------------- 115 Supplemental Documents, including: ---------------------------------------------------------------------------------------------------------------- 116 Attached Document (These are additional Current VICH Negotiated All Formats documents containing information relevant to the AE, such as medical record, radiology, clinical chemistry reports, newspaper articles, and letters.) ---------------------------------------------------------------------------------------------------------------- 117 Attached Document Filename (This is the Current VICH Negotiated All Formats name of the document for paper documents or the electronic file for electronic transmissions.) ---------------------------------------------------------------------------------------------------------------- 118 Attached Document Type (This is a list Current VICH Negotiated All Formats of values describing the type of document that is attached, e.g., necropsy report) ---------------------------------------------------------------------------------------------------------------- 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 ................ ................... ---------------------------------------------------------------------------------------------------------------- [[Page 60273]] 122 17. Did any new illness develop or did Deleted ................ ................... initial diagnosis change after suspect drug started? ---------------------------------------------------------------------------------------------------------------- 123 25. Outcome of Reaction to Date - Died Deleted ................ ................... ---------------------------------------------------------------------------------------------------------------- 124 26. When reaction appeared, treatment Deleted ................ ................... 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) ---------------------------------------------------------------------------------------------------------------- 125 29. Had animal(s) previously reacted to Deleted ................ ................... other drugs? ---------------------------------------------------------------------------------------------------------------- 126 30. Has the attending veterinarian seen Deleted ................ ................... similar reactions to this drug in any other animals? ---------------------------------------------------------------------------------------------------------------- 127 32. Signature of individual responsible Deleted ................ ................... for accuracy of reported information ---------------------------------------------------------------------------------------------------------------- 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 MedWatch\Plus\ Portal Rational Questionnaire, and in the paper form. All the data elements will be captured using the MedWatch\Plus\ 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. Table 4.--Data Element Information Collection for Form FDA 1932a ------------------------------------------------------------------------ Current or New Line No. Data Elements Data Element ------------------------------------------------------------------------ 1 Individual Case Safety Report Number (FDA- New Assigned Number) ------------------------------------------------------------------------ 2 Date of Initial Report. (This is the date the New sender sent the first report of the information.) ------------------------------------------------------------------------ 3 Date Reported (This is the date of this Current current report.) ------------------------------------------------------------------------ 4 Submission Type (This is a list of values New describing the type of submission, e.g., Initial or Followup Report) ------------------------------------------------------------------------ 5 Report Type (This is a list of values New describing the type of information in the report, e.g., adverse event, product problem, or both) ------------------------------------------------------------------------ 6 Manufacturer's Case Number. (The Current manufacturer's case number is given to the sender by the manufacturer of the product if the sender contacted the manufacturer.) ------------------------------------------------------------------------ 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, New Postal/Zip Code, and Country ------------------------------------------------------------------------ 10 Sender Primary and Other Telephone Number, E- New Mail Address, and Fax Number ------------------------------------------------------------------------ 11 Sender Category. (This is a list of values New describing the role/involvement of the sender, e.g., animal owner, physician, etc.) ------------------------------------------------------------------------ [[Page 60274]] 12 Did the sender report to other sources? New ------------------------------------------------------------------------ 13 Sender also reported to other sources. (This New is a list of values describing the sources to which the sender reported the AE or product problem, e.g., manufacturer, distributor, etc.) ------------------------------------------------------------------------ 14 No identity disclosure (This data element Current indicates whether the sender wants their identity disclosed to the manufacturer.) ------------------------------------------------------------------------ 15 Preferred Method of Contact. (This is a list New of values describing the preferred method of contacting the sender, e.g., telephone, e- mail.) ------------------------------------------------------------------------ 16 Healthcare Professional Information, including: ------------------------------------------------------------------------ 17 Healthcare Professional First and Last Name. Current ------------------------------------------------------------------------ 18 Healthcare Professional Street Address, City, Current State/Province, and Postal/Zip Code ------------------------------------------------------------------------ 19 Healthcare Professional Primary and Other Current Phone Number ------------------------------------------------------------------------ 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- New Mail Address ------------------------------------------------------------------------ 25 Owner Street Address, City, State/Province, New Postal/Zip Code, and Country ------------------------------------------------------------------------ 26 Product Information: ------------------------------------------------------------------------ 27 Name of Suspected Product. (This is the name Current of the product suspected of causing the AE or the product with the product problem.) ------------------------------------------------------------------------ 28 Name of Manufacturer Current ------------------------------------------------------------------------ 29 Lot Number Current ------------------------------------------------------------------------ 30 Expiration Date Current ------------------------------------------------------------------------ 31 Diagnosis and/or Reason for
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