
[Federal Register Volume 79, Number 40 (Friday, February 28, 2014)]
[Notices]
[Pages 11446-11448]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-04348]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1620]


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 March 
31, 2014.

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 emailed 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@fda.hhs.gov.

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)--Extension

    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), we 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 our 1996 Federal Register notice did not include on the 
list firms and processors exporting raw, bulk collagen, and gelatin 
intended for 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.

[[Page 11447]]

Therefore, we revised this information collection in order to 
facilitate exports of raw, bulk collagen, and gelatin originating from 
the United States into the EC. We announced OMB approval of the revised 
information collection in the Federal Register of May 10, 2011 (76 FR 
27061).
    We request 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.
    We use the information to maintain lists of firms and processors 
that have demonstrated current compliance with U.S. requirements. We 
provide 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.
    We request 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.
    We use the information to maintain a list of approved firms and 
processors for raw, bulk collagen, and gelatin. We make the list 
available on our Web site. We include 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, we 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, we 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 
regulatory enforcement 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.
    We 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 us 
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 December 26, 2013 (78 FR 78364) 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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                                                     Number of
            Products                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per 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.

    We base our estimates of the number of respondents and total annual 
responses on the submissions that we have received in the past 3 years 
for each product type. We have retained our previous estimates of total 
annual responses because the number of submissions are few and have 
remained relatively stable. 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

[[Page 11448]]

than 15 minutes (0.25 hour) per response. We estimate that we 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. We estimate that 
we 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. We estimate that 
we 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. We estimate that we 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. We estimate 
that we 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. We estimate that we 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: February 24, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-04348 Filed 2-27-14; 8:45 am]
BILLING CODE 4160-01-P


