Agency Information Collection Activities; Proposed Collection; Comment Request; Information From United States Firms and Processors That Export to the European Union, 68424-68426 [2016-23930]
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68424
Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Notices
request by October 17, 2016. Space is
limited; therefore, FDA will select and
notify manufacturers by October 24,
2016. No commercial or promotional
material will be permitted to be
presented or distributed at the public
workshop.
FDA is holding this public workshop
to obtain views from patients on
prosthetic limb devices so that these
perspectives may be considered in the
total product life cycle of prosthetic
limb medical devices. In order to permit
the widest possible opportunity to
obtain public comment, FDA is
soliciting either electronic or written
comments on all aspects of the public
workshop topics. The deadline for
submitting comments related to this
patient workshop is November 30, 2016.
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://
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at the Division of Dockets Management
(see ADDRESSES). A transcript will also
be available in either hardcopy or on
CD–ROM, after submission of a
Freedom of Information request. The
Freedom of Information office address is
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NewsEvents/WorkshopsConferences/
default.htm. (Select this public
workshop from the posted events list).
Dated: September 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–23924 Filed 10–3–16; 8:45 am]
BILLING CODE 4164–01–P
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,
mstockstill on DSK3G9T082PROD with NOTICES
HHS.
ACTION:
Notice.
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
SUMMARY:
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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: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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 https://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.’’
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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
https://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 https://
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: https://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 https://
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.
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
FOR FURTHER INFORMATION CONTACT:
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Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Notices
St., North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
mstockstill on DSK3G9T082PROD with NOTICES
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
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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);
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• 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
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Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Notices
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
respondents
Products
Number of
responses per
respondent
Total annual
responses
Shell Eggs .............................................................
Game Meat and Game Meat Products ................
Gelatin ...................................................................
Collagen ................................................................
10
5
7
18
1
1
1
1
10
5
7
18
Total ...............................................................
........................
........................
........................
1 There
Average burden
per response
0.25
0.25
0.25
0.25
(15
(15
(15
(15
minutes)
minutes)
minutes)
minutes)
Total hours
.........
.........
.........
.........
3
1
2
5
.......................................
11
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2013–N–0115; FDA–
2013–N–0717]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
SUMMARY:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North, 11601 Landsdown St.,
North Bethesda, MD 20852, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the Internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration,
HHS.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
No.
Title of collection
mstockstill on DSK3G9T082PROD with NOTICES
Manufactured Food Regulatory Program Standards ..............................................................................................
Evaluation of the Food and Drug Administration’s General Market Youth Tobacco Prevention Campaign ..........
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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0910–0601
0910–0753
Date approval
expires
9/30/2019
9/30/2019
]]>Agencies
[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]
-----------------------------------------------------------------------
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: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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 https://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 https://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: https://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 https://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, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Information From 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
