69 FR 74 pgs. 20630-20631 - Agency Information Collection Activities; Proposed Collection;Comment Request; Information From United States Processors That Export tothe European Community
Type: NOTICEVolume: 69Number: 74Pages: 20630 - 20631
Docket number: [Docket No. 2004N-0161]
FR document: [FR Doc. 04-8611 Filed 4-15-04; 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-0161]
Agency Information Collection Activities; Proposed Collection;Comment Request; Information From United States Processors That Export tothe European Community
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) isannouncing an opportunity for public comment on the proposed collection ofcertain information by the agency. Under the Paperwork Reduction Act of1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection ofinformation, including each proposed extension of an existing collection ofinformation and to allow 60 days for public comment in response to thenotice. This notice solicits comments on reporting requirements inimplementing the European Union Dairy Export List.
DATES:
Submit written or electronic comments on thecollection of information by June 15, 2004.
ADDRESSES:
Submit electronic comments to: http://www.fda.gov/dockets/ecomments . Submit written comments tothe Division of Dockets Management (HFA-305), Food and DrugAdministration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Allcomments should be identified with the docket number found in brackets inthe heading of this document.
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins, Officeof Management Programs (HFA-250), Food and Drug Administration, 5600Fishers Lane, Rockville, MD 20857,301-827-1223.
SUPPLEMENTARY INFORMATION:
Under the PRA (44 U.S.C. 3501-3520) Federal agencies must obtainapproval from the Office of Management and Budget (OMB) for each collectionof information they conduct or sponsor. "Collection ofinformation" is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) andincludes agency requests or requirements that members of the public submitreports, keep records, or provide information to a third party. Section3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federalagencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposedextension of an existing collection of information, before submitting thecollection to OMB for approval. To comply with this requirement, FDA ispublishing notice of the proposed collection of information set forth inthis document.
With respect to the following collection of information, FDA invitescomments on these topics: (1) Whether the proposed collection ofinformation is necessary for the proper performance of FDA's functions,including whether the information will have practical utility; (2) theaccuracy of FDA's estimate of the burden of the proposed collection ofinformation, including the validity of the methodology and assumptionsused; (3) ways to enhance the quality, utility, and clarity of theinformation to be collected; and (4) ways to minimize the burden of thecollection of information on respondents, including through the use ofautomated collection techniques, when appropriate, and other forms ofinformation technology.
Request for Information From U.S. Processors That Export to theEuropean Community-(OMB Control Number0910-0320)-Extension
The European Community (EC) is a group of 15 European countries (with 10additional countries joining on May 1, 2004), that have agreed to harmonizetheir commodity requirements to facilitate commerce among member States. EClegislation for intraEC trade has been extended to trade with nonECcountries, including the United States. For certain food products,including those listed in this document, EC legislation requires assurancesfrom the responsible authority of the country of origin that the processorof the food is in compliance with applicable regulatory requirements.
With the assistance of trade associations and State authorities, FDArequests information from processors that export certain animal-derivedproducts (e.g., shell eggs, dairy products, game meat, game meat products,animal casings, and gelatin) to EC. FDA uses the information to maintainlists of processors that have demonstrated current compliance with U.S.requirements and provides the lists to EC quarterly. Inclusion on the listis voluntary. EC member countries refer to the lists at ports of entry toverify that products offered for importation to EC from the United Statesare from processors that meet U.S. regulatory requirements. Productsprocessed by firms not on the list are subject to detention and possiblerefusal at the port. FDA requests the following information from eachprocessor:
1. Business name and address;
2. Name and telephone number of person designated as businesscontact;
3. Lists of products presently being shipped to EC and those intended tobe shipped in the next 6 months;
4. Name and address of manufacturing plants for each product;
5. Names and affiliations of any Federal, State, or local governmentalagencies that inspect the plant, government-assigned plant identifier suchas plant number, and last date of inspection; and
6. Assurance that the firm or individual representing the firm andsubmitting a certificate for signature to FDA is aware of and knows thatthey are subject to the provisions of 18 U.S.C 1001. This law provides thatit is a criminal offense to knowingly and willfully make a false statementor alter or counterfeit documents in a matter within the jurisdiction of aU.S. agency.
FDA estimates the burden of this collection of information asfollows:
| Products | No. of Respondents | No. Of Responses per Respondent | Total Annual Responses | Hours per Response | Total Hours |
|---|---|---|---|---|---|
| Shell Eggs | 10 | 1 | 10 | 0.25 | 3 |
| Dairy | 100 | 1 | 100 | 0.25 | 25 |
| Game Meat and Meat Products | 5 | 1 | 5 | 0.25 | 1 |
| Animal Casings | 5 | 1 | 5 | 0.25 | 1 |
| Gelatin | 3 | 1 | 3 | 0.25 | 1 |
| Collagen | 3 | 1 | 3 | 0.25 | 1 |
| Total | 32 | ||||
| 1 There are no capital costs or operating andmaintenance costs associated with this collection ofinformation. | |||||
| Respondent | No. of Respondents | No. of Responses per Respondent | Total annual Responses | Hours per Response | Total Hours |
|---|---|---|---|---|---|
| Trade Association | 15 | 1 | 15 | 8 | 120 |
| State | 50 | 1 | 50 | 8 | 400 |
| Total | 520 | ||||
| 1 There are no capital costs or operating andmaintenance costs associated with this collection of information. | |||||
It is estimated that the annual reporting burden would be no more than32 hours. The time to respond to the questions should take approximately15 minutes using any of the technologies available to transmit theinformation. All of the information asked for should be readily available.The number of respondents is a rough estimate based on volume of exportsand responses received to date. No record retention is required.Therefore, the proposed annual burden for this information collection is 32hours.
Dated: April 9, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-8611 Filed 4-15-04; 8:45 am]
BILLING CODE 4160-01-S