81_FR_68616 81 FR 68424 - Agency Information Collection Activities; Proposed Collection; Comment Request; Information From United States Firms and Processors That Export to the European Union

81 FR 68424 - Agency Information Collection Activities; Proposed Collection; Comment Request; Information From United States Firms and Processors That Export to the European Union

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 192 (October 4, 2016)

Page Range68424-68426
FR Document2016-23930

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).

Federal Register, Volume 81 Issue 192 (Tuesday, October 4, 2016)
[Federal Register Volume 81, Number 192 (Tuesday, October 4, 2016)]
[Notices]
[Pages 68424-68426]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-23930]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
           Products                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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



                                                  68424                        Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Notices

                                                  request by October 17, 2016. Space is                   1995 (the PRA), Federal Agencies are                     Instructions: All submissions received
                                                  limited; therefore, FDA will select and                 required to publish notice in the                     must include the Docket No. FDA–
                                                  notify manufacturers by October 24,                     Federal Register concerning each                      2016–N–2976 for ‘‘Agency Information
                                                  2016. No commercial or promotional                      proposed collection of information,                   Collection Activities; Proposed
                                                  material will be permitted to be                        including each proposed extension of an               Collection; Comment Request;
                                                  presented or distributed at the public                  existing collection of information, and               Information From United States Firms
                                                  workshop.                                               to allow 60 days for public comment in                and Processors That Export to the
                                                     FDA is holding this public workshop                  response to the notice. This notice                   European Union.’’ Received comments
                                                  to obtain views from patients on                        solicits comments on reporting                        will be placed in the docket and, except
                                                  prosthetic limb devices so that these                   requirements in implementing the lists                for those submitted as ‘‘Confidential
                                                  perspectives may be considered in the                   of United States (U.S.) firms/processors              Submissions,’’ publicly viewable at
                                                  total product life cycle of prosthetic                  exporting shell eggs, game meat and                   http://www.regulations.gov or at the
                                                  limb medical devices. In order to permit                game meat products, gelatin, and                      Division of Dockets Management
                                                  the widest possible opportunity to                      collagen to the European Union (the                   between 9 a.m. and 4 p.m., Monday
                                                  obtain public comment, FDA is                           EU).                                                  through Friday.
                                                  soliciting either electronic or written                 DATES: Submit either electronic or                       • Confidential Submissions—To
                                                  comments on all aspects of the public                   written comments on the collection of                 submit a comment with confidential
                                                  workshop topics. The deadline for                       information by December 5, 2016.                      information that you do not wish to be
                                                  submitting comments related to this                     ADDRESSES: You may submit comments                    made publicly available, submit your
                                                  patient workshop is November 30, 2016.                  as follows:                                           comments only as a written/paper
                                                     Transcripts: Please be advised that as                                                                     submission. You should submit two
                                                  soon as a transcript is available, it will              Electronic Submissions
                                                                                                                                                                copies total. One copy will include the
                                                  be accessible at http://                                  Submit electronic comments in the                   information you claim to be confidential
                                                  www.regulations.gov. It may be viewed                   following way:                                        with a heading or cover note that states
                                                  at the Division of Dockets Management                     • Federal eRulemaking Portal: http://               ‘‘THIS DOCUMENT CONTAINS
                                                  (see ADDRESSES). A transcript will also                 www.regulations.gov. Follow the                       CONFIDENTIAL INFORMATION.’’ The
                                                  be available in either hardcopy or on                   instructions for submitting comments.                 Agency will review this copy, including
                                                  CD–ROM, after submission of a                           Comments submitted electronically,                    the claimed confidential information, in
                                                  Freedom of Information request. The                     including attachments, to http://                     its consideration of comments. The
                                                  Freedom of Information office address is                www.regulations.gov will be posted to                 second copy, which will have the
                                                  available on the Agency’s Web site at                   the docket unchanged. Because your                    claimed confidential information
                                                  http://www.fda.gov. A link to the                       comment will be made public, you are                  redacted/blacked out, will be available
                                                  transcripts will also be available                      solely responsible for ensuring that your
                                                                                                                                                                for public viewing and posted on http://
                                                  approximately 45 days after the public                  comment does not include any
                                                                                                                                                                www.regulations.gov. Submit both
                                                  workshop on the Internet at http://                     confidential information that you or a
                                                                                                                                                                copies to the Division of Dockets
                                                  www.fda.gov/MedicalDevices/                             third party may not wish to be posted,
                                                                                                                                                                Management. If you do not wish your
                                                  NewsEvents/WorkshopsConferences/                        such as medical information, your or
                                                                                                                                                                name and contact information to be
                                                  default.htm. (Select this public                        anyone else’s Social Security number, or
                                                                                                                                                                made publicly available, you can
                                                  workshop from the posted events list).                  confidential business information, such
                                                                                                                                                                provide this information on the cover
                                                                                                          as a manufacturing process. Please note
                                                    Dated: September 26, 2016.                                                                                  sheet and not in the body of your
                                                                                                          that if you include your name, contact
                                                  Leslie Kux,                                                                                                   comments and you must identify this
                                                                                                          information, or other information that
                                                  Associate Commissioner for Policy.                      identifies you in the body of your                    information as ‘‘confidential.’’ Any
                                                  [FR Doc. 2016–23924 Filed 10–3–16; 8:45 am]             comments, that information will be                    information marked as ‘‘confidential’’
                                                  BILLING CODE 4164–01–P                                  posted on http://www.regulations.gov.                 will not be disclosed except in
                                                                                                            • If you want to submit a comment                   accordance with 21 CFR 10.20 and other
                                                                                                          with confidential information that you                applicable disclosure law. For more
                                                  DEPARTMENT OF HEALTH AND                                do not wish to be made available to the               information about FDA’s posting of
                                                  HUMAN SERVICES                                          public, submit the comment as a                       comments to public dockets, see 80 FR
                                                                                                          written/paper submission and in the                   56469, September 18, 2015, or access
                                                  Food and Drug Administration                            manner detailed (see ‘‘Written/Paper                  the information at: http://www.fda.gov/
                                                                                                          Submissions’’ and ‘‘Instructions’’).                  regulatoryinformation/dockets/
                                                  [Docket No. FDA–2016–N–2976]
                                                                                                                                                                default.htm.
                                                                                                          Written/Paper Submissions
                                                  Agency Information Collection                                                                                    Docket: For access to the docket to
                                                  Activities; Proposed Collection;                           Submit written/paper submissions as                read background documents or the
                                                  Comment Request; Information From                       follows:                                              electronic and written/paper comments
                                                  United States Firms and Processors                         • Mail/Hand delivery/Courier (for                  received, go to http://
                                                  That Export to the European Union                       written/paper submissions): Division of               www.regulations.gov and insert the
                                                                                                          Dockets Management (HFA–305), Food                    docket number, found in brackets in the
                                                  AGENCY:    Food and Drug Administration,                and Drug Administration, 5630 Fishers                 heading of this document, into the
                                                  HHS.                                                    Lane, Rm. 1061, Rockville, MD 20852.                  ‘‘Search’’ box and follow the prompts
                                                                                                             • For written/paper comments
mstockstill on DSK3G9T082PROD with NOTICES




                                                  ACTION:   Notice.                                                                                             and/or go to the Division of Dockets
                                                                                                          submitted to the Division of Dockets
                                                                                                                                                                Management, 5630 Fishers Lane, Rm.
                                                  SUMMARY:   The Food and Drug                            Management, FDA will post your
                                                                                                                                                                1061, Rockville, MD 20852.
                                                  Administration (FDA or we) is                           comment, as well as any attachments,
                                                  announcing an opportunity for public                    except for information submitted,                     FOR FURTHER INFORMATION CONTACT:    FDA
                                                  comment on the proposed collection of                   marked and identified, as confidential,               PRA Staff, Office of Operations, Food
                                                  certain information by the Agency.                      if submitted as detailed in                           and Drug Administration, Three White
                                                  Under the Paperwork Reduction Act of                    ‘‘Instructions.’’                                     Flint North, 10A63, 11601 Landsdown


                                             VerDate Sep<11>2014   19:01 Oct 03, 2016   Jkt 241001   PO 00000   Frm 00027   Fmt 4703   Sfmt 4703   E:\FR\FM\04OCN1.SGM   04OCN1


                                                                               Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Notices                                           68425

                                                  St., North Bethesda, MD 20852,                          guaranteed compliance with applicable                    • Names and affiliations of any
                                                  PRAStaff@fda.hhs.gov.                                   regulatory requirements and that                      Federal, State, and local governmental
                                                  SUPPLEMENTARY INFORMATION: Under the                    shipments of these products must be                   Agencies that inspect the plant,
                                                  PRA (44 U.S.C. 3501–3520), Federal                      accompanied by documents that certify                 government assigned plant identifier,
                                                  Agencies must obtain approval from the                  the products’ compliance with                         such as plant number and last date of
                                                  Office of Management and Budget                         applicable regulatory standards. Section              inspection; and
                                                  (OMB) for each collection of                            801(e) of the Federal Food, Drug, and                    • A copy of the most recent (within
                                                  information they conduct or sponsor.                    Cosmetic Act (21 U.S.C. 381(e))                       1 year of the date of application)
                                                  ‘‘Collection of information’’ is defined                authorizes FDA to provide the                         inspection report issued by a State, local
                                                  in 44 U.S.C. 3502(3) and 5 CFR                          certification described in this document.             or Federal public health regulatory
                                                  1320.3(c) and includes Agency requests                  As stated in the notice published in the              Agency and a copy of a recent
                                                  or requirements that members of the                     Federal Register of April 4, 1996 (61 FR              laboratory analysis as required by the
                                                  public submit reports, keep records, or                 15077), we established a list of U.S.                 EU of the finished product including:
                                                  provide information to a third party.                   firms and processors eligible to export               Total aerobic bacteria, coliforms (30
                                                  Section 3506(c)(2)(A) of the PRA (44                    shell eggs, dairy products, and game                  degrees C), coliforms (44.5 degrees C),
                                                  U.S.C. 3506(c)(2)(A)) requires Federal                  meat and game meat products to the EU.                anaerobic sulphite-reducing bacteria (no
                                                  Agencies to provide a 60-day notice in                  In response to changing EU                            gas production), Clostridium
                                                  the Federal Register concerning each                    requirements, we revised this                         perfringens, Staphylococcus aureus,
                                                  proposed collection of information,                     information collection and lists of                   Salmonella, arsenic, lead, cadmium,
                                                  including each proposed extension of an                 eligible exporters in order to facilitate             mercury, chromium, copper, zinc,
                                                  existing collection of information,                     U.S. exports of gelatin and collagen to               moisture (105 degrees C), ash (550
                                                  before submitting the collection to OMB                 the EU. In 2001, we revised this                      degrees C), sulfur dioxide, and hydrogen
                                                  for approval. To comply with this                       collection to include firms and                       peroxide.
                                                  requirement, FDA is publishing notice                   processors intending to export gelatin                   We use the information to maintain
                                                  of the proposed collection of                           products to the EU (66 FR 12802,                      lists of firms and processors that have
                                                  information set forth in this document.                 February 28, 2001) and in 2010, we                    demonstrated current compliance with
                                                     With respect to the following                        revised the collection again to include               U.S. requirements. We make the lists
                                                  collection of information, FDA invites                  firms and processors intending to export              available on our Web site. We include
                                                  comments on these topics: (1) Whether                   collagen products to the EU (75 FR                    on the lists only firms and processors
                                                  the proposed collection of information                  51077, August 18, 2010).                              that are not the subject of an unresolved
                                                  is necessary for the proper performance                    We request the following information               regulatory enforcement action or
                                                  of FDA’s functions, including whether                   from each firm or processor seeking to                unresolved warning letter. If a listed
                                                  the information will have practical                     be included on the lists of eligible                  firm or processor subsequently becomes
                                                  utility; (2) the accuracy of FDA’s                      exporters for shell eggs, and game meat               the subject of a regulatory enforcement
                                                  estimate of the burden of the proposed                  and game meat products (dairy products                action or an unresolved warning letter,
                                                  collection of information, including the                will be covered under OMB control                     we will view such a circumstance as
                                                  validity of the methodology and                         number 0910–0509):                                    evidence that the firm or processor is no
                                                  assumptions used; (3) ways to enhance                      • Business name and address;                       longer in compliance with applicable
                                                                                                             • Name and telephone number of                     U.S. laws and regulations. Should this
                                                  the quality, utility, and clarity of the
                                                                                                          person designated as business contact;                occur, we will take steps to remove that
                                                  information to be collected; and (4)                       • Lists of products presently being
                                                  ways to minimize the burden of the                                                                            firm or processor from the list and send
                                                                                                          shipped to the EU and those intended                  a revised list to the EU authorities,
                                                  collection of information on                            to be shipped in the next 6 months;
                                                  respondents, including through the use                                                                        usually within 48 to 72 hours after the
                                                                                                             • Name and address of manufacturing                relevant regulatory enforcement action.
                                                  of automated collection techniques,                     plants for each product; and
                                                  when appropriate, and other forms of                                                                          If a firm or processor has been delisted
                                                                                                             • Names and affiliations of any
                                                  information technology.                                                                                       as a result of a regulatory enforcement
                                                                                                          Federal, State, or local governmental
                                                                                                                                                                action or unresolved warning letter, the
                                                  Information From U.S. Firms and                         Agencies that inspect the plant,
                                                                                                                                                                firm or processor will have to reapply
                                                  Processors That Export to the EU (OMB                   government-assigned plant identifier
                                                                                                                                                                for inclusion on the list once the
                                                  Control Number 0910–0320)—Extension                     such as plant number, and last date of
                                                                                                                                                                regulatory action has been resolved.
                                                                                                          inspection.
                                                     The EU is a group of 28 European                        We request the following information                  We update the lists of firms and
                                                  countries that have agreed to harmonize                 from each firm or processor seeking to                processors eligible to export products of
                                                  their commodity requirements to                         be included on the list of eligible                   animal origin to the EU quarterly. Firms
                                                  facilitate commerce among member                        exporters for gelatin and collagen                    and processors placed on lists of eligible
                                                  States. For certain food products,                      products:                                             exporters are subject to audit by FDA
                                                  including those listed in this document,                   • Food Facility Registration Number                and EU officials. Complete requests for
                                                  EU legislation requires assurances from                 and Pin Number (if applicable);                       inclusion must be submitted to us every
                                                  the responsible authority of the country                   • Business name and address;                       12 months to remain on these lists.
                                                  of origin that the processor of the food                   • Name, telephone number, facsimile                Inclusion on the lists is voluntary.
                                                  is in compliance with applicable                        number, and email address of main                     However, products of animal origin
                                                  regulatory requirements. Regulation                                                                           from firms or processors not on lists of
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                                                                                                          business contact person;
                                                  (EC) No 854/2004 of the European                           • List of products presently shipped               eligible exporters for these products are
                                                  Parliament and of the European Council                  to the EU and those intended to be                    not eligible for export certificates for
                                                  states that products of animal origin                   shipped within the next 2 years;                      these products, and these products may
                                                  may only be imported from                                  • Name and address of the                          be detained at EU ports of entry.
                                                  establishments that appear on a list of                 manufacturing and processing plant for                   Description of Respondents: The
                                                  establishments for which the competent                  each product (manufacturer type for                   respondents to this collection of
                                                  authority of the exporting country has                  primary producer);                                    information include U.S. producers of


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                                                  68426                                   Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Notices

                                                  shell eggs, game meat and game meat                                         FDA estimates the burden of this
                                                  products, gelatin, and collagen.                                          collection of information as follows:

                                                                                                                TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
                                                                                                                                                             Number of
                                                                                                                                  Number of                                              Total annual                    Average burden
                                                                                Products                                                                   responses per                                                                                      Total hours
                                                                                                                                 respondents                                              responses                       per response
                                                                                                                                                             respondent

                                                  Shell Eggs .............................................................                          10                          1                          10      0.25   (15    minutes)       .........                   3
                                                  Game Meat and Game Meat Products ................                                                  5                          1                           5      0.25   (15    minutes)       .........                   1
                                                  Gelatin ...................................................................                        7                          1                           7      0.25   (15    minutes)       .........                   2
                                                  Collagen ................................................................                         18                          1                          18      0.25   (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                                    for a total of seven annual responses.                                         ACTION:       Notice.
                                                  of respondents and total annual                                           Each submission is estimated to take
                                                  responses on the submissions that we                                      0.25 hour per response for a total of 1.75                                     SUMMARY:    The Food and Drug
                                                  have received in the past 3 years for                                     hours, rounded to 2 hours. We estimate                                         Administration (FDA) is publishing a
                                                  each product type. To calculate the                                       that we will receive one submission                                            list of information collections that have
                                                  estimate for the hours per response                                       from 18 collagen producers annually,                                           been approved by the Office of
                                                  values, we assumed that the information                                   for a total of 18 annual responses. Each                                       Management and Budget (OMB) under
                                                  requested is readily available to the                                     submission is estimated to take 0.25                                           the Paperwork Reduction Act of 1995.
                                                  submitter. We expect that the submitter                                   hour per response for a total of 4.5
                                                  will need to gather information from                                      hours, rounded to 5 hours. The                                                 FOR FURTHER INFORMATION CONTACT:    FDA
                                                  appropriate persons in the submitter’s                                    estimated burden for collagen producers                                        PRA Staff, Office of Operations, Food
                                                  company and to prepare this                                               includes animal casings, which have                                            and Drug Administration, Three White
                                                  information for submission. We believe                                    been listed separately in previous                                             Flint North, 11601 Landsdown St.,
                                                  that this effort should take no longer                                    notices. Therefore, the proposed annual                                        North Bethesda, MD 20852, PRAStaff@
                                                  than 15 minutes (0.25 hour) per                                           burden for this information collection is                                      fda.hhs.gov.
                                                  response. We estimate that we will                                        11 hours.
                                                  receive 1 submission from 10 shell egg                                                                                                                   SUPPLEMENTARY INFORMATION:     The
                                                                                                                              Dated: September 28, 2016.                                                   following is a list of FDA information
                                                  producers annually, for a total of 10
                                                                                                                            Leslie Kux,                                                                    collections recently approved by OMB
                                                  annual responses. Each submission is
                                                  estimated to take 0.25 hour per response                                  Associate Commissioner for Policy.                                             under section 3507 of the Paperwork
                                                  for a total of 2.5 hours, rounded to 3                                    [FR Doc. 2016–23930 Filed 10–3–16; 8:45 am]                                    Reduction Act of 1995 (44 U.S.C. 3507).
                                                  hours. This collection has previously                                     BILLING CODE 4164–01–P                                                         The OMB control number and
                                                  covered information collected to                                                                                                                         expiration date of OMB approval for
                                                  maintain lists of eligible exporters of                                                                                                                  each information collection are shown
                                                  dairy products; dairy products will be                                    DEPARTMENT OF HEALTH AND                                                       in table 1. Copies of the supporting
                                                  covered under OMB control number                                          HUMAN SERVICES                                                                 statements for the information
                                                  0910–0509, so the estimated burden has                                                                                                                   collections are available on the Internet
                                                  been removed from this collection. We                                     Food and Drug Administration
                                                                                                                                                                                                           at http://www.reginfo.gov/public/do/
                                                  estimate that we will receive one                                                                                                                        PRAMain. An Agency may not conduct
                                                  submission from five game meat and                                        [Docket Nos. FDA–2013–N–0115; FDA–
                                                                                                                            2013–N–0717]                                                                   or sponsor, and a person is not required
                                                  game meat product producers annually,                                                                                                                    to respond to, a collection of
                                                  for a total of five annual responses. Each                                Agency Information Collection                                                  information unless it displays a
                                                  submission is estimated to take 0.25                                      Activities; Announcement of Office of                                          currently valid OMB control number.
                                                  hour per response for a total of 1.25                                     Management and Budget Approvals
                                                  hours, rounded to 1 hour. We estimate
                                                  that we will receive one submission                                       AGENCY:         Food and Drug Administration,
                                                  from seven gelatin producers annually,                                    HHS.

                                                                                                   TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
                                                                                                                                                                                                                                   OMB control               Date approval
                                                                                                                         Title of collection                                                                                          No.                       expires

                                                  Manufactured Food Regulatory Program Standards ..............................................................................................                                         0910–0601                9/30/2019
                                                  Evaluation of the Food and Drug Administration’s General Market Youth Tobacco Prevention Campaign ..........                                                                          0910–0753                9/30/2019
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                                                    Dated: September 27, 2016.
                                                  Leslie Kux,
                                                  Associate Commissioner for Policy.
                                                  [FR Doc. 2016–23898 Filed 10–3–16; 8:45 am]
                                                  BILLING CODE 4164–01–P




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Document Created: 2016-10-04 03:03:17
Document Modified: 2016-10-04 03:03:17
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesSubmit either electronic or written comments on the collection of information by December 5, 2016.
ContactFDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]
FR Citation81 FR 68424 

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