[Federal Register Volume 63, Number 110 (Tuesday, June 9, 1998)] [Notices] [Pages 31505-31506] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 98-15271] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 97N-0503] Agency Information Collection Activities; Submission for OMB Review; Comment Request 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 July 9, 1998. ADDRESSES: Submit written comments on the collection of information to the Office of Information and Regulatory Affairs, OMB, New Executive Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attention: Desk Officer for FDA. FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information Resources Management (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 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. New Animal Drug Application (NADA), Form FDA 356 V, 21 CFR Part 514--(OMB Control Number 0910-0032--Reinstatement) Under the Federal Food, Drug, and Cosmetic Act (the act), FDA has the responsibility for the approval of new animal drugs that are safe and effective. Section 512(b) of the act (21 U.S.C. 360b(b)), requires that a sponsor submit and receive approval of a NADA before interstate marketing is allowed. The regulations implementing statutory requirements for NADA approval have been codified under 21 CFR part 514. NADA applicants generally use a single form, FDA 356 V. The NADA must contain, among other things, safety and effectiveness data for the drug, labeling, a list of components, manufacturing and controls information, and complete information on any methods used to determine residues of drug chemicals in edible tissues. While the NADA is pending, an amended application may be submitted for proposed changes. After a NADA has been approved, a supplemental application must be submitted for certain proposed changes, including changes beyond the variations provided for in the NADA and other labeling changes. An amended application and a supplemental application may omit statements concerning which no change is proposed. This information is reviewed by FDA scientific personnel to ensure that the intended use of an animal drug, whether as a pharmaceutical dosage form, in drinking water, or in medicated feed is safe and effective. The respondents are pharmaceutical firms that produce veterinary products and commercial feed mills. FDA estimates the burden for this collection of information as follows: [[Page 31506]] 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 356 V 514.1 and 514.6 190 6.76 1,824 211.6 271,694 514.8 and 514.9 30 8,520 514.11 1 1,824 Total burden hours 282,038 ---------------------------------------------------------------------------------------------------------------- \1\There are no capital costs or operating and maintenance costs associated with this collection of information. The estimate of the burden hours required for reporting are based on fiscal year 1996 data. The burden estimate includes original NADA's, supplemental NADA`s, and amendments to unapproved applications. Dated: June 2, 1998. William K. Hubbard, Associate Commissioner for Policy Coordination. [FR Doc. 98-15271 Filed 6-8-98; 8:45 am] BILLING CODE 4160-01-F