Document ID: FDA-2016-N-2976-0003
Agency: fda
Document Type: Notice
Title: 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 Union
Posted Date: 2017-04-24T04:00Z

[Federal Register Volume 82, Number 77 (Monday, April 24, 2017)]
[Notices]
[Pages 18915-18916]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08181]

[[Page 18915]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2976]

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 Union

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) 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 May 24, 
2017.

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: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726.

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 U.S. Firms and Processors That Export to the EU OMB 
Control Number 0910-0320--Extension

    The European Union (EU) is a group of 28 European countries that 
have agreed to harmonize their commodity requirements to facilitate 
commerce among member States. For certain food products, including 
those listed in this document, EU 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. 
Regulation (EC) No. 854/2004 of the European Parliament and of the 
European Council states that products of animal origin may only be 
imported from establishments that appear on a list of establishments 
for which the competent authority of the exporting country has 
guaranteed compliance with applicable regulatory requirements and that 
shipments of these products must be accompanied by documents that 
certify the products' compliance with applicable regulatory standards. 
Section 801(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
381(e)) authorizes FDA to provide the certification described in 
Regulation (EC) No. 854/2004. 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 eligible to export shell eggs, dairy 
products, and game meat and game meat products to the EU. In response 
to changing EU requirements, we revised this information collection and 
lists of eligible exporters in order to facilitate U.S. exports of 
gelatin and collagen to the EU. In 2001, we revised this collection to 
include firms and processors intending to export gelatin products to 
the EU (66 FR 12802, February 28, 2001) and in 2010, we revised the 
collection again to include firms and processors intending to export 
collagen products to the EU (75 FR 51077, August 18, 2010).
    We request the following information from each firm or processor 
seeking to be included on the lists of eligible exporters for shell 
eggs, and game meat and game meat products (dairy products will be 
covered under OMB control number 0910-0509):
     Business name and address;
     name and telephone number of person designated as business 
contact;
     lists of products presently being shipped to the EU 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 request the following information from each firm or processor 
seeking to be included on the list of eligible exporters for gelatin 
and collagen products:
     Food Facility Registration Number and Pin Number (if 
applicable);
     business name and address;
     name, telephone number, fax number, and email address of 
main business contact person;
     list of products presently shipped to the EU and those 
intended to be shipped within the next 2 years;
     name and address of the manufacturing and processing plant 
for each product (manufacturer type for primary producer);
     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 EU of the finished product including: Total 
aerobic bacteria, coliforms (30 degrees C), coliforms (44.5 degrees C), 
anaerobic sulphite-reducing bacteria (no gas production), Clostridium 
perfringens, Staphylococcus aureus, Salmonella, arsenic, lead, cadmium, 
mercury, chromium, copper, zinc, moisture (105 degrees C), ash (550 
degrees C), sulfur dioxide, and hydrogen peroxide.
    We use the information to maintain lists of firms and processors 
that have demonstrated current compliance with U.S. requirements. We 
make the lists available on our Web site. We include on the lists only 
firms and processors that are not the subject of an unresolved 
regulatory enforcement action or unresolved warning letter. 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 EU 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 quarterly the lists of firms and processors eligible to 
export products of animal origin to the EU. Firms and processors placed 
on lists of eligible exporters are subject to audit by FDA and EU 
officials. Complete requests for inclusion on the lists of eligible 
exporters, which is voluntary, must be submitted 12 months to remain on 
the list of firms and processors eligible to export products of animal 
origin to the EU. However, products of

[[Page 18916]]

animal origin from firms or processors not on lists of eligible 
exporters for these products are not eligible for export certificates 
for these products, and these products may be detained at EU ports of 
entry.
    Description of Respondents: The respondents to this collection of 
information include U.S. producers of shell eggs, game meat and game 
meat products, gelatin, and collagen.
    In the Federal Register of October 4, 2016 (81 FR 68424), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one comment which was not PRA-
related, and therefore is not addressed in this supporting statement.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
           Products                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Shell Eggs....................              10               1              10  .25 (15 minutes)               3
Game Meat and Game Meat                      5               1               5  .25 (15 minutes)               1
 Products.
Gelatin.......................               7               1               7  .25 (15 minutes)               2
Collagen......................              18               1              18  .25 (15 minutes)               5
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................              11
----------------------------------------------------------------------------------------------------------------
\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. 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 hours. This collection has previously covered information 
collected to maintain lists of eligible exporters of dairy products; 
dairy products will be covered under OMB control number 0910-0509, so 
the estimated burden has been removed from this collection. 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 seven gelatin producers annually, for a total of seven 
annual responses. Each submission is estimated to take 0.25 hour per 
response for a total of 1.75 hours, rounded to 2 hours. We estimate 
that we will receive 1 submission from 18 collagen producers annually, 
for a total of 18 annual responses. Each submission is estimated to 
take 0.25 hour per response for a total of 4.5 hours, rounded to 5 
hours. The estimated burden for collagen producers includes animal 
casings, which have been listed separately in previous notices. 
Therefore, the proposed annual burden for this information collection 
is 11 hours.

    Dated: April 17, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08181 Filed 4-21-17; 8:45 am]
 BILLING CODE 4164-01-P