Agency Information Collection Activities; Proposed Collection; Comment Request; Information From United States Firms and Processors That Export to the European Community, 78364-78366 [2013-30804]
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Federal Register / Vol. 78, No. 248 / Thursday, December 26, 2013 / Notices
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2013–30809 Filed 12–24–13; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1620]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Information From
United States Firms and Processors
That Export to the European
Community
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (the PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on reporting
requirements in implementing the lists
of United States (U.S.) firms/processors
exporting shell eggs, dairy products,
game meat, game meat products, animal
casings, gelatin, and collagen to the
European Community (the EC).
DATES: Submit either electronic or
written comments on the collection of
information by February 24, 2014.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
emcdonald on DSK67QTVN1PROD with NOTICES
SUMMARY:
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information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Information From United States Firms
and Processors That Export to the
European Community (OMB Control
Number 0910–0320)—Extension
The EC is a group of 27 European
countries that have agreed to harmonize
their commodity requirements to
facilitate commerce among member
States. EC legislation for intra-EC trade
has been extended to trade with non-EC
countries, including the United States.
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For certain food products, including
those listed in this document, EC
legislation requires assurances from the
responsible authority of the country of
origin that the processor of the food is
in compliance with applicable
regulatory requirements. The European
Commission, the executive branch of
the EC, requires countries trading with
any of the EC member countries to
provide lists of firms and processors
approved to export certain animalderived commodities to the EC. As
stated in the notice published in the
Federal Register of April 4, 1996 (61 FR
15077), we established a list of U.S.
firms and processors that intended to
export shell eggs, dairy products, and
game meat and game meat products to
the EC.
Although our 1996 Federal Register
notice did not include on the list firms
and processors exporting gelatin and
raw, bulk collagen intended for human
consumption, EC directives require that
shipments of gelatin and raw, bulk
collagen products be accompanied by
certification stating that the product,
derived from ruminant bones, bovine
hides, and pigskins, has been produced
in compliance with EC Council
Directive 2003/863/EC. The directive
contains the requirements for sourcing,
manufacture, transport, and storage of
raw materials and manufacture of
finished products and requires lists
identifying non-EC firms and processors
that meet EC requirements and have the
appropriate animal and public health
certificates. Therefore, we revised this
information collection in order to
facilitate exports of gelatin and raw,
bulk collagen originating from the
United States into the EC. We
announced OMB approval of the revised
information collection in the Federal
Register of May 10, 2011 (76 FR 27061).
We request the following information
from each firm or processor seeking to
be included on the lists for shell eggs,
dairy products, game meat, game meat
products, and animal casings:
• Business name and address;
• Name and telephone number of
person designated as business contact;
• Lists of products presently being
shipped to the EC and those intended to
be shipped in the next 6 months;
• Name and address of manufacturing
plants for each product; and
• Names and affiliations of any
Federal, State, or local governmental
Agencies that inspect the plant,
government-assigned plant identifier
such as plant number, and last date of
inspection.
We use the information to maintain
lists of firms and processors that have
demonstrated current compliance with
E:\FR\FM\26DEN1.SGM
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Federal Register / Vol. 78, No. 248 / Thursday, December 26, 2013 / Notices
U.S. requirements. We provide the lists
to the EC quarterly. Inclusion on the list
is voluntary. EC member countries refer
to the lists at ports of entry to verify that
products offered for importation to the
EC from the United States are from firms
and processors that meet U.S. regulatory
requirements. Products processed by
firms and processors not on the lists are
subject to detention and possible refusal
at the port.
We request the following information
from each firm or processor seeking to
be included on the lists for gelatin and
raw, bulk collagen:
• Business name and address;
• Name, telephone number, and
email address of contact person;
• List of products presently shipped
to the EC and those intended to be
shipped within the next 2 years;
• Name and address of the
manufacturing and processing plant for
each product;
• Names and affiliations of any
Federal, State, and local governmental
Agencies that inspect the plant,
government assigned plant identifier,
such as plant number and last date of
inspection; and
• A copy of the most recent (within
1 year of the date of application)
inspection report issued by a State, local
or Federal public health regulatory
Agency and a copy of a recent
laboratory analysis as required by the
EC of the finished product including:
Total aerobic bacteria, coliforms (30 °C),
coliforms (44.5 °C), anaerobic sulphitereducing bacteria (no gas production),
Clostridium perfringens,
Staphylococcus aureus, Salmonella,
arsenic, lead, cadmium, mercury,
chromium, copper, zinc, moisture (105
°C), ash (550 °C), sulfur dioxide, and
hydrogen peroxide.
We use the information to maintain a
list of approved firms and processors for
gelatin and raw, bulk collagen. We make
the list available on our Web site. We
include on the list only firms and
processors that are not the subject of an
unresolved regulatory enforcement
action. If a listed firm or processor
subsequently becomes the subject of a
regulatory enforcement action or an
unresolved warning letter, we will view
such a circumstance as evidence that
the firm or processor is no longer in
compliance with applicable U.S. laws
and regulations. Should this occur, we
will take steps to remove that firm or
processor from the list and send a
revised list to the EC authorities, usually
within 48 to 72 hours after the relevant
regulatory enforcement action. If a firm
or processor has been delisted as a
result of a regulatory enforcement action
or unresolved warning letter, the firm or
processor will have to reapply for
inclusion on the list once the regulatory
action has been resolved.
We update the list of firms and
processors eligible to export gelatin and
raw, bulk collagen to the EC quarterly.
Firms and processors placed on the
approved exporters list are subject to
audit by FDA and EC officials. Complete
requests for inclusion must be
submitted to us every 12 months to
remain on the list. Inclusion on the list
is voluntary. However, gelatin and raw,
bulk collagen products from firms or
processors not on the approved
exporters list for these products will not
receive an export certificate, and these
products may be detained at EC ports of
entry.
Description of Respondents: The
respondents to this collection of
information include U.S. producers of
shell eggs, dairy products, game meat,
game meat products, animal casings,
gelatin, and collagen.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Number of respondents
Number of responses per
respondent
Shell Eggs ............................................................................
Dairy .....................................................................................
Game Meat and Game Meat Products ...............................
Animal Casings ....................................................................
Gelatin ..................................................................................
Collagen ...............................................................................
10
120
5
5
3
3
1
1
1
1
1
1
10
120
5
5
3
3
0.25
0.25
0.25
0.25
0.25
0.25
3
30
1
1
1
1
Total ..............................................................................
........................
........................
........................
........................
37
Products
emcdonald on DSK67QTVN1PROD with NOTICES
1 There
Total annual
responses
Average burden per response
Total hours
are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimates of the number
of respondents and total annual
responses on the submissions that we
have received in the past 3 years for
each product type. We have retained our
previous estimates of total annual
responses because the number of
submissions are few and have remained
relatively stable. To calculate the
estimate for the hours per response
values, we assumed that the information
requested is readily available to the
submitter. We expect that the submitter
will need to gather information from
appropriate persons in the submitter’s
company and to prepare this
information for submission. We believe
that this effort should take no longer
than 15 minutes (0.25 hour) per
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response. We estimate that we will
receive 1 submission from 10 shell egg
producers annually, for a total of 10
annual responses. Each submission is
estimated to take 0.25 hour per response
for a total of 2.5 hours, rounded to 3. We
estimate that we will receive 1
submission from 120 dairy product
producers annually, for a total of 120
annual responses. Each submission is
estimated to take 0.25 hour per response
for a total of 30 hours. We estimate that
we will receive one submission from
five game meat and game meat product
producers annually, for a total of five
annual responses. Each submission is
estimated to take 0.25 hour per response
for a total of 1.25 hours, rounded to 1
hour. We estimate that we will receive
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one submission from five animal casings
producers annually, for a total of five
annual responses. Each submission is
estimated to take 0.25 hour per response
for a total of 1.25 hours, rounded to 1
hour. We estimate that we will receive
one submission from three gelatin
producers annually, for a total of three
annual responses. Each submission is
estimated to take 0.25 hour per response
for a total of 0.75 hour, rounded to 1
hour. We estimate that we will receive
one submission from three collagen
producers annually, for a total of three
annual responses. Each submission is
estimated to take 0.25 hour per response
for a total of 0.75 hour, rounded to 1
hour. Therefore, the proposed annual
E:\FR\FM\26DEN1.SGM
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78366
Federal Register / Vol. 78, No. 248 / Thursday, December 26, 2013 / Notices
burden for this information collection is
37 hours.
Dated: December 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–30804 Filed 12–24–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1615]
Draft Generic Drug User Fee Act
Information Technology Plan;
Availability for Comment
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability for public comment of the
draft information technology (IT) plan
entitled ‘‘GDUFA Information
Technology Plan.’’ This plan is intended
to provide FDA’s approach for
enhancing business processes, data
quality and consistency, supporting
technologies, and IT operations as
described in the Generic Drug User Fee
Act (GDUFA) Performance Goals and
Procedures for Fiscal Years 2013
through 2017. FDA is publishing a draft
version of the IT plan for comment to
allow industry and other interested
stakeholders to provide feedback as
FDA moves towards a fully automated
standards-based environment that
enhances the regulatory review process
for human pharmaceuticals.
DATES: Submit either electronic or
written comments by February 24, 2014.
ADDRESSES: Submit written requests for
single copies of the draft ‘‘GDUFA
Information Technology Plan’’ to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft plan.
Submit electronic comments on the
draft plan to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Cheryl Ford, Center for Drug Evaluation
emcdonald on DSK67QTVN1PROD with NOTICES
SUMMARY:
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and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–6737, UserFeesProgramInformatics@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Signed into law on July 9, 2012,
GDUFA is designed to speed the
delivery of safe and effective generic
drugs to the public. GDUFA increases
FDA’s authorities and responsibilities to
address issues such as drug shortages,
drug supply chain, safety, security, and
drug innovation. As generic drugs
account for more than three-quarters of
all prescriptions dispensed in the
United States, GDUFA authorizes FDA
to collect user fees from industry that
will provide funding to expand and
modernize FDA’s generic drug
regulatory process.
The draft GDUFA IT plan considers
assumptions, available resources, and
statutory requirements that conform to
the Food and Drug Administration
Safety and Innovation Act (FDASIA),
signed into law on July 9, 2012. Section
1136 of FDASIA, Electronic Submission
of Applications, gives FDA the authority
to require a standardized electronic
format for the submission of information
and data in standardized formats.
Section 1136 addresses abbreviated new
drug applications under the GDUFA
program as well as investigational new
drug applications, biologics license
applications, and new drug applications
under the Prescription Drug User Fee
Act program and describes new
standards and processes affecting drug
and biologics approvals, drug supply
chain, and other topics related to human
pharmaceuticals. The draft GDUFA IT
plan describes key activities for
enabling progress toward achieving
GDUFA IT goals.
II. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/ForIndustry/
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Frm 00042
Fmt 4703
Sfmt 4703
UserFees/default.htm or https://
www.regulations.gov.
Dated: December 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–31008 Filed 12–24–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–1566]
Draft Guidance for Industry on Naming
of Drug Products Containing Salt Drug
Substances; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Naming of Drug
Products Containing Salt Drug
Substances.’’ The United States
Pharmacopeial (U.S.P.) Convention has
adopted a monograph naming policy
that changed the nomenclature for
compendial drug products that contain
a salt. Under the new policy, drug
names and strengths for new
compendial drug products will be based
on the active moiety. The name and
strength of the active ingredient (e.g.,
salt) will appear elsewhere on the drug
product label and labeling. The policy
became official on May 1, 2013. This
draft guidance describes the U.S.P.
policy, discusses the Center for Drug
Evaluation and Research’s (CDER’s)
application of the policy, and
recommends how CDER and industry
can implement the policy.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by March 26,
2014.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
SUMMARY:
E:\FR\FM\26DEN1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 248 (Thursday, December 26, 2013)]
[Notices]
[Pages 78364-78366]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-30804]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1620]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Information From United States Firms and Processors
That Export to the European Community
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on reporting requirements in
implementing the lists of United States (U.S.) firms/processors
exporting shell eggs, dairy products, game meat, game meat products,
animal casings, gelatin, and collagen to the European Community (the
EC).
DATES: Submit either electronic or written comments on the collection
of information by February 24, 2014.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Information From United States Firms and Processors That Export to the
European Community (OMB Control Number 0910-0320)--Extension
The EC is a group of 27 European countries that have agreed to
harmonize their commodity requirements to facilitate commerce among
member States. EC legislation for intra-EC trade has been extended to
trade with non-EC countries, including the United States. For certain
food products, including those listed in this document, EC legislation
requires assurances from the responsible authority of the country of
origin that the processor of the food is in compliance with applicable
regulatory requirements. The European Commission, the executive branch
of the EC, requires countries trading with any of the EC member
countries to provide lists of firms and processors approved to export
certain animal-derived commodities to the EC. As stated in the notice
published in the Federal Register of April 4, 1996 (61 FR 15077), we
established a list of U.S. firms and processors that intended to export
shell eggs, dairy products, and game meat and game meat products to the
EC.
Although our 1996 Federal Register notice did not include on the
list firms and processors exporting gelatin and raw, bulk collagen
intended for human consumption, EC directives require that shipments of
gelatin and raw, bulk collagen products be accompanied by certification
stating that the product, derived from ruminant bones, bovine hides,
and pigskins, has been produced in compliance with EC Council Directive
2003/863/EC. The directive contains the requirements for sourcing,
manufacture, transport, and storage of raw materials and manufacture of
finished products and requires lists identifying non-EC firms and
processors that meet EC requirements and have the appropriate animal
and public health certificates. Therefore, we revised this information
collection in order to facilitate exports of gelatin and raw, bulk
collagen originating from the United States into the EC. We announced
OMB approval of the revised information collection in the Federal
Register of May 10, 2011 (76 FR 27061).
We request the following information from each firm or processor
seeking to be included on the lists for shell eggs, dairy products,
game meat, game meat products, and animal casings:
Business name and address;
Name and telephone number of person designated as business
contact;
Lists of products presently being shipped to the EC and
those intended to be shipped in the next 6 months;
Name and address of manufacturing plants for each product;
and
Names and affiliations of any Federal, State, or local
governmental Agencies that inspect the plant, government-assigned plant
identifier such as plant number, and last date of inspection.
We use the information to maintain lists of firms and processors
that have demonstrated current compliance with
[[Page 78365]]
U.S. requirements. We provide the lists to the EC quarterly. Inclusion
on the list is voluntary. EC member countries refer to the lists at
ports of entry to verify that products offered for importation to the
EC from the United States are from firms and processors that meet U.S.
regulatory requirements. Products processed by firms and processors not
on the lists are subject to detention and possible refusal at the port.
We request the following information from each firm or processor
seeking to be included on the lists for gelatin and raw, bulk collagen:
Business name and address;
Name, telephone number, and email address of contact
person;
List of products presently shipped to the EC and those
intended to be shipped within the next 2 years;
Name and address of the manufacturing and processing plant
for each product;
Names and affiliations of any Federal, State, and local
governmental Agencies that inspect the plant, government assigned plant
identifier, such as plant number and last date of inspection; and
A copy of the most recent (within 1 year of the date of
application) inspection report issued by a State, local or Federal
public health regulatory Agency and a copy of a recent laboratory
analysis as required by the EC of the finished product including: Total
aerobic bacteria, coliforms (30 [deg]C), coliforms (44.5 [deg]C),
anaerobic sulphite-reducing bacteria (no gas production), Clostridium
perfringens, Staphylococcus aureus, Salmonella, arsenic, lead, cadmium,
mercury, chromium, copper, zinc, moisture (105 [deg]C), ash (550
[deg]C), sulfur dioxide, and hydrogen peroxide.
We use the information to maintain a list of approved firms and
processors for gelatin and raw, bulk collagen. We make the list
available on our Web site. We include on the list only firms and
processors that are not the subject of an unresolved regulatory
enforcement action. If a listed firm or processor subsequently becomes
the subject of a regulatory enforcement action or an unresolved warning
letter, we will view such a circumstance as evidence that the firm or
processor is no longer in compliance with applicable U.S. laws and
regulations. Should this occur, we will take steps to remove that firm
or processor from the list and send a revised list to the EC
authorities, usually within 48 to 72 hours after the relevant
regulatory enforcement action. If a firm or processor has been delisted
as a result of a regulatory enforcement action or unresolved warning
letter, the firm or processor will have to reapply for inclusion on the
list once the regulatory action has been resolved.
We update the list of firms and processors eligible to export
gelatin and raw, bulk collagen to the EC quarterly. Firms and
processors placed on the approved exporters list are subject to audit
by FDA and EC officials. Complete requests for inclusion must be
submitted to us every 12 months to remain on the list. Inclusion on the
list is voluntary. However, gelatin and raw, bulk collagen products
from firms or processors not on the approved exporters list for these
products will not receive an export certificate, and these products may
be detained at EC ports of entry.
Description of Respondents: The respondents to this collection of
information include U.S. producers of shell eggs, dairy products, game
meat, game meat products, animal casings, gelatin, and collagen.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
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 3
Dairy........................... 120 1 120 0.25 30
Game Meat and Game Meat Products 5 1 5 0.25 1
Animal Casings.................. 5 1 5 0.25 1
Gelatin......................... 3 1 3 0.25 1
Collagen........................ 3 1 3 0.25 1
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Total....................... .............. .............. .............. .............. 37
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
We base our estimates of the number of respondents and total annual
responses on the submissions that we have received in the past 3 years
for each product type. We have retained our previous estimates of total
annual responses because the number of submissions are few and have
remained relatively stable. To calculate the estimate for the hours per
response values, we assumed that the information requested is readily
available to the submitter. We expect that the submitter will need to
gather information from appropriate persons in the submitter's company
and to prepare this information for submission. We believe that this
effort should take no longer than 15 minutes (0.25 hour) per response.
We estimate that we will receive 1 submission from 10 shell egg
producers annually, for a total of 10 annual responses. Each submission
is estimated to take 0.25 hour per response for a total of 2.5 hours,
rounded to 3. We estimate that we will receive 1 submission from 120
dairy product producers annually, for a total of 120 annual responses.
Each submission is estimated to take 0.25 hour per response for a total
of 30 hours. We estimate that we will receive one submission from five
game meat and game meat product producers annually, for a total of five
annual responses. Each submission is estimated to take 0.25 hour per
response for a total of 1.25 hours, rounded to 1 hour. We estimate that
we will receive one submission from five animal casings producers
annually, for a total of five annual responses. Each submission is
estimated to take 0.25 hour per response for a total of 1.25 hours,
rounded to 1 hour. We estimate that we will receive one submission from
three gelatin producers annually, for a total of three annual
responses. Each submission is estimated to take 0.25 hour per response
for a total of 0.75 hour, rounded to 1 hour. We estimate that we will
receive one submission from three collagen producers annually, for a
total of three annual responses. Each submission is estimated to take
0.25 hour per response for a total of 0.75 hour, rounded to 1 hour.
Therefore, the proposed annual
[[Page 78366]]
burden for this information collection is 37 hours.
Dated: December 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-30804 Filed 12-24-13; 8:45 am]
BILLING CODE 4160-01-P
