[Federal Register: November 18, 1998 (Volume 63, Number 222)] [Notices] [Page 64090-64091] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr18no98-98] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 98N-0308] Agency Information Collection Activities; Submission for OMB Review; Comment Request; Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA). DATES: Submit written comments on the collection of information by December 18, 1998. ADDRESSES: Submit written comments on the collection of information to Office of Information and Regulatory Affairs, OMB, New Executive Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: Desk Officer for FDA. FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information Resources Management (HFA-250), Food and Drug Administration, 5600 Fishers Lane, rm. 16B-26, Rockville, MD 20857, 301-827-1472. SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA (44 U.S.C. 3507), FDA has submitted the following proposed collection of information to OMB for review and clearance. Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report--21 CFR Part 510--(OMB Control Number 0910-0012) Section 512(l) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(l)), 21 CFR 510.300, 510.301, and 510.302 require that applicants of approved new animal drug applications (NADA`s), submit within 15-working days of receipt, complete records of reports of certain adverse drug reactions and unusual failure of new animal drugs. Other reporting requirements of adverse reactions to these drugs must be reported annually or semiannually in a specific format. This continuous monitoring of approved new animal drugs, affords the primary means by which FDA obtains information regarding potential problems in safety and effectiveness of marketed animal drugs and potential manufacturing problems. Data already on file with FDA is not adequate because animal drug effects can change over time and less apparent effects may take years to manifest themselves. Reports are reviewed along with those previously submitted for a particular drug to determine if any change is needed in the product or labeling, such as package insert changes, dosage changes, additional warnings or contraindications, or product reformulation. Adverse reaction reports are required to be submitted by the drug manufacturer on FDA Forms 1932 or 1932a (voluntary reporting form), following complaints from animal owners or veterinarians. Product defects and lack of effectiveness complaints are submitted to FDA by the drug manufacturer following their own detection of a problem or complaints from product users or their veterinarians also using FDA Forms 1932 and 1932a. Form FDA 2301 is used for the required transmittal of periodic reports and promotional material for new animal drugs. Respondents to this collection of information are applicants of approved NADA's. In the Federal Register of June 10, 1998 (63 FR 31788), the agency requested comments on the proposed collection of information using the reporting forms cited previously. In response, FDA received one comment to the docket. The comment expressed favor in submitting adverse drug reactions, lack of effectiveness and product defect reports (data), electronically and suggested that Form FDA 1932 be formatted in industry standard format (Microsoft Word or Word Perfect), so that these data can be submitted electronically. The Center for Veterinary Medicine (CVM), is developing procedures for electronic submission of adverse drug reactions, lack of effectiveness and product defects. Currently, CVM is not able to accept electronic submission of this specific data until the electronic submission data standards are in place and the hardware/software technology is set up. In the meantime, the current regulations do allow for acceptance of computerized reports under 21 CFR 510.302(c)(1), in lieu of Form FDA 1932. The information contained in a computerized report and the sequence in which it is presented must be equivalent to that required in the hard copy of Form FDA 1932 and should include the valid OMB control number identified with Form FDA 1932, i.e., 0910-0012. The computerized report must be submitted in duplicate to CVM for approval prior to initial use. Further, once the forms are approved and disseminated for use, CVM will post electronic copies via the Worldwide [[Page 64091]] Web (WWW). Both the computerized report and forms available via the WWW must be submitted via paper. FDA estimates the burden for this collection of information as follows: Table 1.--Estimated Annual Reporting Burden1 ---------------------------------------------------------------------------------------------------------------- Annual Form No. 21 CFR Section No. of Frequency per Total Annual Hours per Total Hours Respondents Response Responses Response ---------------------------------------------------------------------------------------------------------------- Form FDA 2301 510.302a 190 19.74 3,750 0.5 1,875 Form FDA 1932 510.302b 190 15.25 2,900 1.0 2,900 Form FDA 1932a (voluntary) 510.302b 100 1.0 100 1.0 100 Total Burden Hours 4,875 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Table 2.--Estimated Annual Recordkeeping Burden1 ---------------------------------------------------------------------------------------------------------------- Annual Total Annual 21 CFR Section No. of Frequency per Response per Hours per Total Hours Recordkeepers Recordkeeping Recordkeeper Recordkeeper ---------------------------------------------------------------------------------------------------------------- 510.300(a) and 510.301(a) 190 15.26 3,750 10.35 38,812 510.300(b) and 510.301(b) 190 19.74 2,900 0.50 1,450 Total Burden Hours 40,262 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. The estimate of the times required for record preparation and maintenance is based on agency communication with industry. Other information needed to calculate the total burden hours (i.e., adverse drug reaction, lack of effectiveness, and product defect reports) are derived from agency records and experience. Dated: November 10, 1998. William K. Hubbard, Associate Commissioner for Policy Coordination. [FR Doc. 98-30752 Filed 11-17-98; 8:45 am] BILLING CODE 4160-01-F