70 FR 67 pgs. 18030-18031 - Agency Information Collection Activities; Submission for Office ofManagement and Budget Review; Comment Request; Exports: Notification andRecordkeeping Requirements
Type: NOTICEVolume: 70Number: 67Pages: 18030 - 18031
Docket number: [Docket No. 2004N-0541]
FR document: [FR Doc. 05-7023 Filed 4-7-05; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0541]
Agency Information Collection Activities; Submission for Office ofManagement and Budget Review; Comment Request; Exports: Notification andRecordkeeping Requirements
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) isannouncing that a proposed collection of information has been submitted tothe Office of Management and Budget (OMB) for review and clearance underthe Paperwork Reduction Act of 1995.
DATES:
Fax written comments on the collection ofinformation by May 9, 2005.
ADDRESSES:
OMB is still experiencing significant delaysin the regular mail, including first class and express mail, and messengerdeliveries are not being accepted. To ensure that comments on theinformation collection are received, OMB recommends that written commentsbe 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:
Jonna Capezzuto,Office of Management Programs (HFA-250), Food and DrugAdministration, 5600 Fishers Lane, Rockville, MD 20857,301-827-4659.
SUPPLEMENTARY INFORMATION:
In compliance with 44U.S.C. 3507, FDA has submitted the following proposed collection ofinformation to OMB for review and clearance.
Exports: Notification and Recordkeeping Requirements-21CFR Part 1 (OMB Control Number 0910-0482)-Extension
In the Federal Register of December 27, 2004 (69 FR77255), FDA published a 60-day notice requesting public comment on theinformation collection provisions. No comments were received.
The total burden estimate of 43,214 is based on the number ofnotifications received by the relevant FDA centers in fiscal year 2004, orthe last year the figures were available.
The respondents to this information collection are exporters who havenotified FDA of their intent to export unapproved products that may not besold or marketed in the United States as allowed under section 801(e) ofthe Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 381). Ingeneral, the notification identifies the product being exported (e.g.,name, description, and, in some cases, country of destination) andspecifies where the notification should be sent. These notifications aresent only for an initial export; subsequent exports of the same product tothe same destination, or in the case of certain countries identified insection 802(b) of the act (21 U.S.C. 382), would not result in anotification to FDA.
The recordkeepers for this information collection are exporters whoexport human drugs, biologics, devices, animal drugs, foods, and cosmeticsthat may not be sold in the United States to maintain records demonstratingtheir compliance with the requirements in section 801(e)(1) of the act.
| 21 CFR Section | No. of Respondents | Annual Frequency per Response | Total Annual Responses | Hours per Respondent | Total Hours |
|---|---|---|---|---|---|
| 1.101(d) and (e) | 419 | 2.8 | 1,164 | 17 | 19,788 |
| 1 There are no capital costs or operating andmaintenance costs associated with this collection of information. | |||||
| 21 CFR Section | No. of Recordkeepers | Annual Frequency per Record | Total Annual Records | Hours per Recordkeeper | Total Hours |
|---|---|---|---|---|---|
| 1.101(b) and (c) | 324 | 2.8 | 901 | 26 | 23,426 |
| 1 There are no capital costs or operating andmaintenance costs associated with this collection of information. | |||||
Dated: April 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-7023 Filed 4-7-05; 8:45 am]
BILLING CODE 4160-01-S