[Federal Register: September 14, 1998 (Volume 63, Number 177)] [Notices] [Page 49130-49131] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr14se98-73] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 98N-0373] Agency Information Collection Activities; Submission for OMB Review; Comment Request; FDA Recall Regulations 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 October 14, 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, Attn: Desk Officer for FDA. FOR FURTHER INFORMATION CONTACT: JonnaLynn P. Capezzuto, Office of Information Resources Management (HFA-250), Food and Drug Administration,5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. 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. FDA Recall Regulations--Part 7 (21 CFR Part 7), Subpart C--(OMB Control Number 0910-0249--Extension) These regulations were established to provide guidance to manufacturers on recall responsibilities. These responsibilities include development of a recall strategy; providing complete details of the recall reason, risk evaluation, quantity produced, distribution information, firm's recall strategy and a contact official; notifying direct accounts of the recall and to provide recipients with a ready means of reporting to the recalling firm; provide periodic status reports so FDA can assess the progress of the recall. The recall provisions provide the information necessary for FDA to monitor recalls and assess the adequacy of a firm's efforts in a recall. It also permits FDA to evaluate whether a recall has been completed in a manner that assures that unreasonable risk of substantial harm to the public health has been eliminated. The guidelines apply to all regulated products (i.e., food, including animal feed; drugs, including animal drugs; medical devices, cosmetics; and biological products intended for human use. In the Federal Register of June 9, 1998 (63 FR 31502), the agency requested comments on the proposed collections of information. No significant comments were received. FDA estimates the burden of this collection of information as follows: Table 1.--Estimated Annual Reporting Burden 1 ---------------------------------------------------------------------------------------------------------------- Annual 21 CFR Section No. of Frequency per Total Annual Hours per Total Hours Respondents Response Responses Response ---------------------------------------------------------------------------------------------------------------- 7.42 1,712 1 1,712 1.8 3,082 7.46 and 7.49 1,712 1 1,712 4 6,848 7.53 1,712 1 1,712 36 61,632 7.55(b) 1,712 1 1,712 2 3,424 Totals 74,986 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs associated with this collection of information. [[Page 49131]] Due to a typographical error, the ``Annual Frequency per Response'' for 21 CFR 7.42, 7.46 and 7.49, 7.53, and 7.55(b) were reported as ``4'' in FDA's June 9, 1998, notice providing 60 days for public comment on this collection of information. Therefore, the totals for ``Total Annual Responses'' and ``Total Hours'' were reported incorrectly. Table 1 of this document reflects the correct annual frequency per response, total annual responses and total burden hours. Dated: September 3, 1998. William K. Hubbard, Associate Commissioner for Policy Coordination. [FR Doc. 98-24496 Filed 9-11-98; 8:45 am] BILLING CODE 4160-01-F