
[Federal Register Volume 78, Number 248 (Thursday, December 26, 2013)]
[Notices]
[Pages 78364-78366]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-30804]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 or we) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on reporting requirements in 
implementing the lists of United States (U.S.) firms/processors 
exporting shell eggs, dairy products, game meat, game meat products, 
animal casings, gelatin, and collagen to the European Community (the 
EC).

DATES: Submit either electronic or written comments on the collection 
of information by February 24, 2014.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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

    The 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 gelatin and raw, bulk collagen 
intended for human consumption, EC directives require that shipments of 
gelatin and raw, bulk collagen 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 and requires lists identifying non-EC firms and 
processors that meet EC requirements and have the appropriate animal 
and public health certificates. Therefore, we revised this information 
collection in order to facilitate exports of gelatin and raw, bulk 
collagen 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

[[Page 78365]]

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 gelatin and raw, bulk collagen:
     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), sulfur dioxide, and hydrogen peroxide.
    We use the information to maintain a list of approved firms and 
processors for gelatin and raw, bulk collagen. 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 
gelatin and raw, bulk collagen 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, gelatin and raw, bulk collagen 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.
    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 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

[[Page 78366]]

burden for this information collection is 37 hours.

    Dated: December 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-30804 Filed 12-24-13; 8:45 am]
BILLING CODE 4160-01-P


