Notices. Notice

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BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004N-0436] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Registration and Listing AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a proposed collection of information has been submitted to the Office of Management and Budget

(OMB)for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by February 14, 2005. ADDRESSES: OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer for FDA, FAX: 202-395-6974. FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. **Medical Device Registration and Listing—21 CFR Parts 807.22, 807.31, and 807.40 (OMB Control Number 0910-0387)—Extension** Section 510 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360) requires domestic establishments engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices intended for human use and commercial distribution register their establishments and list the devices they manufacture with FDA. This is accomplished by completing FDA Form 2891 “Registration of Device Establishment” and FDA Form 2892 “Medical Device Listing.” The term “device” is defined in section 201(h) of the act (21 U.S.C. 321) and includes all in vitro diagnostic products and in vitro diagnostic biological products not subject to licensing under section 351 of the Public Health Service Act (42 U.S.C. 262). The FDA Modernization Act of 1997 (FDAMA) added a requirement for foreign establishments to appoint a U.S. agent and submit the information to FDA on Form 2891 as part of its initial and updated registration information. In addition, each year, active, registered establishments must notify FDA of changes to the current registration and device listing for the establishment. Annual changes to current registration information are preprinted on FDA Form 2891a and sent to registered establishments. The form must be sent back to FDA's Center for Devices and Radiological Health, even if no changes have occurred. Changes to listing information are submitted on Form 2892. Under § 807.31 (21 CFR 807.31), each owner or operator is required to maintain an historical file containing the labeling and advertisements in use on the date of initial listing, and in use after October 10, 1978, but before the date of initial listing. The owner or operator must maintain in the historical file any labeling or advertisements in which a material change has been made anytime after initial listing, but may discard labeling and advertisements from the file 3 years after the date of the last shipment of a discontinued device by an owner or operator. Along with the recordkeeping requirements previously mentioned in this document, the owner or operator must be prepared to submit to FDA all labeling and advertising (§ 807.31(e)). Section 807.40 (21 CFR 807.40) describes the role of the U.S. agent. The U.S. agent must reside or have a physical place of business in the United States, and each foreign establishment must submit U.S. agent information as part of its initial and updated registration process. The information collected through these provisions is used by FDA to identify firms subject to FDA's regulations and is used to identify geographic distribution in order to effectively allocate FDA's field resources for these inspections and to identify the class of the device that determines the inspection frequency. When complications occur with a particular device or component, manufacturers of similar or related devices can be easily identified. The likely respondents to this information collection will be domestic and foreign device establishments and U.S. agents who must register and submit a device list to FDA (e.g., establishments engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices intended for human use and commercial distribution). In the **Federal Register** of October 29, 2004 (69 FR 63156), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. FDA estimates the burden of this collection of information as follows: **Estimated Annual Reporting Burden** ** Table 1A.—Estimated Year 1 Annual Reporting Burden 1 ** 21 CFR Section FDA Form No. of Respondents Annual Frequency of Response Total Annual Responses Hours Per Response Total Hours 807.22(a) and 807.40 Form 2891 Initial and Updates Establishment Registration 2,900 1 2,900 .25 725 807.22(b) Form 2892 Device Listing-initial and updates 4,400 1 4,400 .50 2,200 807.22(a) and 807.40 Form 2891a-Registration Update 25,100 1 25,100 .25 6,275 807.31(e) 200 1 200 .50 100 Total Year 1 Burden Hours 9,300 1 There are no capital costs or operating and maintenance costs associated with this collection of information. **Table 1B.—Estimated Subsequent Years Annual Reporting Burden** 1 21 CFR Section FDA Form No. of Respondents Annual Frequency of Response Total Annual Responses Hours Per Response Total Hours 807.22(a) and 807.40 Form 2891 Initial and Updates Establishment Registration 3,100 1 3,100 .25 775 807.22(b) Form 2892 Device Listing-initial and updates 4,600 1 4,600 .50 2,300 807.22(a) and 807.40 Form 2891a-Registration Update 25,100 1 25,100 .25 6,275 807.31(e) 200 1 200 .50 100 Total Year 2 and 3 Burden Hours 9,450 1 There are no capital costs or operating and maintenance costs associated with this collection of information. **Table 2.—Estimated Annual Recordkeeping Burden** 21 CFR Section No. of Recordkeepers Annual Frequency per Recordkeeper Total Annual Records Hours Per Recordkeeper Total Hours 807.31 16,200 4 64,800 .50 32,400 Total Burden Hours 32,400 The burdens are explained as follows: The annual reporting burden hours to respondents for registering establishments and listing devices is estimated to be 9,450 hours, and recordkeeping burden hours for respondents is estimated to be 32,400 hours. The estimates cited in tables 1A, 1B, and 2 of this document are based primarily upon the annual FDA accomplishment report, which includes actual FDA registration and listing figures from fiscal year

(FY)2003. These estimates are also based on FDA estimates of FY 2003 data from current systems, conversations with industry and trade association representatives, and from internal review of the documents referred to in tables 1A, 1B, and 2 of this document. According to 21 CFR part 807, all owners/operators are required to list, and establishments and U.S. agents are required to register. Each owner/operator has an average of two establishments, according to statistics gathered from FDA's registration and listing database. The database has 25,100 active establishments listed in it. Based on past experience, the agency anticipated that approximately 7,300 registrations will be processed during the first year, and 3,100 thereafter. FDA anticipates reviewing 200 historical files annually. Dated: January 7, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05-676 Filed 1-12-05; 8:45 am]

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