
[Federal Register Volume 75, Number 225 (Tuesday, November 23, 2010)]
[Notices]
[Pages 71444-71446]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-29483]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0422]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Information From 
United States Firms and Processors That Export to the European 
Community

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 
December 23, 2010.

ADDRESSES: 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: FDA Desk Officer, 
FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0320. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

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.

Information From United States Firms and Processors That Export to the 
European Community (OMB Control Number 0910-0320)--Revision

    The European Community (EC) is a group of 27 European countries 
that have agreed to harmonize their commodity requirements to 
facilitate commerce among member States. EC legislation for intra-EC 
trade has been extended to trade with non-EC countries, including the 
United States. For certain food products, including those listed in 
this document, EC legislation requires assurances from the responsible 
authority of the country of origin that the processor of the food is in 
compliance with applicable regulatory requirements. The European 
Commission, the executive branch of the EC, requires countries trading 
with any of the EC member countries to provide lists of firms and 
processors approved to export certain animal-derived commodities to the 
EC. As stated in the notice published in the Federal Register of April 
4, 1996 (61 FR 15077), FDA established a list of U.S. firms and 
processors that intended to export shell eggs, dairy products, and game 
meat and game meat products to the EC.
    Although the 1996 Federal Register notice did not include on the 
list firms and processors exporting raw, bulk collagen, and gelatin 
intended for

[[Page 71445]]

human consumption, EC directives require that shipments of raw, bulk 
collagen, and gelatin products be accompanied by certification stating 
that the product, derived from ruminant bones, bovine hides, and 
pigskins, has been produced in compliance with EC Council Directive 
2003/863/EC. The directive contains the requirements for sourcing, 
manufacture, transport, and storage of raw materials and manufacture of 
finished products. Chapter III, Article 23, of the directive requires 
lists identifying non-EC firms and processors that meet EC requirements 
and have the appropriate animal and public health certificates. 
Therefore, FDA is revising this information collection in order to 
facilitate exports of raw, bulk collagen, and gelatin originating from 
the United States into the EC. The description of the data elements to 
be collected from firms and processors of raw, bulk collagen, and 
gelatin products follows. The estimated burden hours associated with 
this information collection remain 37 total hours. FDA requests the 
following information from each firm or processor seeking to be 
included on the lists for shell eggs, dairy products, game meat, game 
meat products, and animal casings:
     Business name and address;
     Name and telephone number of person designated as business 
contact;
     Lists of products presently being shipped to the EC and 
those intended to be shipped in the next 6 months;
     Name and address of manufacturing plants for each product; 
and
     Names and affiliations of any Federal, State, or local 
governmental agencies that inspect the plant, government-assigned plant 
identifier such as plant number, and last date of inspection.
    FDA uses the information to maintain lists of firms and processors 
that have demonstrated current compliance with U.S. requirements and 
provides the lists to the EC quarterly. Inclusion on the list is 
voluntary. EC member countries refer to the lists at ports of entry to 
verify that products offered for importation to the EC from the United 
States are from firms and processors that meet U.S. regulatory 
requirements. Products processed by firms and processors not on the 
lists are subject to detention and possible refusal at the port.
    FDA requests the following information from each firm or processor 
seeking to be included on the lists for raw, bulk collagen, and 
gelatin:
     Business name and address;
     Name, telephone number, and email address of contact 
person;
     List of products presently shipped to the EC and those 
intended to be shipped within the next 2 years;
     Name and address of the manufacturing and processing plant 
for each product;
     Names and affiliations of any Federal, State, and local 
governmental agencies that inspect the plant, government assigned plant 
identifier, such as plant number and last date of inspection; and
     A copy of the most recent (within 1 year of the date of 
application) inspection report issued by a State, local or Federal 
public health regulatory agency and a copy of a recent laboratory 
analysis as required by the EC of the finished product including: Total 
aerobic bacteria, coliforms (30 [deg]C), coliforms (44.5 [deg]C), 
anaerobic sulphite-reducing bacteria (no gas production), Clostridium 
perfringens, Staphylococcus aureus, Salmonella, Arsenic, Lead, Cadmium, 
Mercury, Chromium, Copper, Zinc, Moisture (105 [deg]C), Ash (550 
[deg]C), SO2, and H2O2.
    FDA will use the information to maintain a list of approved firms 
and processors that will be posted on FDA's Web site. FDA intends to 
place on the list only firms and processors that are not the subject of 
an unresolved regulatory enforcement action. If a listed firm or 
processor subsequently becomes the subject of a regulatory enforcement 
action or an unresolved warning letter, FDA will view such a 
circumstance as evidence that the firm or processor is no longer in 
compliance with applicable U.S. laws and regulations. Should this 
occur, FDA will take steps to remove that firm or processor from the 
list and send a revised list to the EC authorities, usually within 48 
to 72 hours after the relevant FDA action. If a firm or processor has 
been delisted as a result of a regulatory enforcement action or 
unresolved warning letter, the firm or processor will have to reapply 
for inclusion on the list once the regulatory action has been resolved.
    FDA intends to update the list of firms and processors eligible to 
export raw, bulk collagen, and gelatin to the EC quarterly. Firms and 
processors placed on the approved exporters list are subject to audit 
by FDA and EC officials. Complete requests for inclusion must be 
submitted to FDA every 12 months to remain on the list. Inclusion on 
the list is voluntary. However, raw, bulk collagen, and gelatin 
products from firms or processors not on the approved exporters list 
for these products will not receive an export certificate, and these 
products may be detained at EC ports of entry.
    Description of Respondents: The respondents to this collection of 
information include U.S. producers of shell eggs, dairy products, game 
meat, game meat products, animal casings, gelatin, and collagen.
    In the Federal Register of August 18, 2010 (75 FR 51077), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                      Annual
            Products                 Number of    frequency  per   Total annual      Hours per      Total hours
                                    respondents      response        responses       response
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Shell Eggs......................              10               1              10            0.25               3
Dairy...........................             120               1             120            0.25              30
Game Meat and Game 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
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    Total.......................  ..............  ..............  ..............  ..............              37
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 71446]]

    FDA bases its estimates of the number of respondents and total 
annual responses on the submissions that the Agency has received in the 
past 3 years for each product type. To calculate the estimate for the 
hours per response values, we assumed that the information requested is 
readily available to the submitter. We expect that the submitter will 
need to gather information from appropriate persons in the submitter's 
company and to prepare this information for submission. We believe that 
this effort should take no longer than 15 minutes (0.25 hour) per 
response. FDA estimates that it will receive 1 submission from 10 shell 
egg producers annually, for a total of 10 annual responses. Each 
submission is estimated to take 0.25 hour per response for a total of 
2.5 hours, rounded to 3. FDA estimates that it will receive 1 
submission from 120 dairy product producers annually, for a total of 
120 annual responses. Each submission is estimated to take 0.25 hour 
per response for a total of 30 hours. FDA estimates that it will 
receive one submission from five game meat and game meat product 
producers annually, for a total of five annual responses. Each 
submission is estimated to take 0.25 hour per response for a total of 
1.25 hours, rounded to 1 hour. FDA estimates that it will receive one 
submission from five animal casings producers annually, for a total of 
five annual responses. Each submission is estimated to take 0.25 hour 
per response for a total of 1.25 hours, rounded to 1 hour. FDA 
estimates that it will receive one submission from three gelatin 
producers annually, for a total of three annual responses. Each 
submission is estimated to take 0.25 hour per response for a total of 
0.75 hour, rounded to 1 hour. FDA estimates that it will receive one 
submission from three collagen producers annually, for a total of three 
annual responses. Each submission is estimated to take 0.25 hour per 
response for a total of 0.75 hour, rounded to 1 hour. Therefore, the 
proposed annual burden for this information collection is 37 hours.

    Dated: November 18, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-29483 Filed 11-22-10; 8:45 am]
BILLING CODE 4160-01-P


