[Federal Register Volume 81, Number 192 (Tuesday, October 4, 2016)]
[Notices]
[Pages 68424-68426]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23930]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 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, game meat and game meat products, gelatin, and 
collagen to the European Union (the EU).

DATES: Submit either electronic or written comments on the collection 
of information by December 5, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-N-2976 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Information From United States 
Firms and Processors That Export to the European Union.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown

[[Page 68425]]

St., North Bethesda, MD 20852, [email protected].

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

    The 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 this document. 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, facsimile 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 the lists of firms and processors eligible to export 
products of animal origin to the EU quarterly. Firms and processors 
placed on lists of eligible exporters are subject to audit by FDA and 
EU officials. Complete requests for inclusion must be submitted to us 
every 12 months to remain on these lists. Inclusion on the lists is 
voluntary. However, products of 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

[[Page 68426]]

shell eggs, game meat and game meat products, 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 (15                       3
                                                                                 minutes).
Game Meat and Game Meat                      5               1               5  0.25 (15                       1
 Products.                                                                       minutes).
Gelatin.......................               7               1               7  0.25 (15                       2
                                                                                 minutes).
Collagen......................              18               1              18  0.25 (15                       5
                                                                                 minutes).
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................              11
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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. 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 one 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: September 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-23930 Filed 10-3-16; 8:45 am]
 BILLING CODE 4164-01-P