Agency Information Collection Activities; Proposed Collection; Comment Request; Establishing and Maintaining Lists of U.S. Milk Product Manufacturers/Processors With Interest in Exporting, 27485-27487 [2017-12356]
Download as PDF
<![CDATA[
Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices
system records outside the agency, see
Appendix I (Authorized Disclosures and
Routine Uses Applicable to All FTC
Privacy Act Systems of Records),
available on the FTC’s privacy program
page at www.ftc.gov/privacy and at 73
FR 33592, 36333–36334 (June 12, 2008).
POLICIES AND PRACTICES FOR STORAGE OF
RECORDS:
POLICIES AND PRACTICES FOR RETRIEVAL OF
RECORDS:
Indexed by name of requesting party
and subject matter of request. Records
can also be searched by name, address,
phone number, fax number, and email
of the requesting party, subject matter of
the request, requestor organization,
FOIA number, and staff member
assigned to the request.
Records are retained and disposed of
in accordance with General Records
Schedule 4.2, issued by the National
Archives and Records Administration.
ADMINISTRATIVE, TECHNICAL, AND PHYSICAL
SAFEGUARDS:
Requests, appeals, and responses
available to the public, as described
above. Access to nonpublic system
records is restricted to FTC personnel or
contractors whose responsibilities
require access. Nonpublic paper records
are temporary, maintained in lockable
file cabinets or offices, and destroyed
once the request is complete. Access to
electronic records is controlled by ‘‘user
ID’’ and password combination and
other electronic access or network
controls (e.g., firewalls). FTC buildings
are guarded and monitored by security
personnel, cameras, ID checks, and
other physical security measures.
RECORD ACCESS PROCEDURES:
pmangrum on DSK3GDR082PROD with NOTICES
See § 4.13 of the FTC’s Rules of
Practice, 16 CFR 4.13. For additional
guidance, see also Appendix II (How To
Make A Privacy Act Request), available
on the FTC’s privacy program page at
www.ftc.gov/privacy and at 73 FR
33592, 33634 (June 12, 2008).
CONTESTING RECORD PROCEDURES:
See § 4.13 of the FTC’s Rules of
Practice, 16 CFR 4.13. For additional
guidance, see also Appendix II (How To
Make A Privacy Act Request), available
on the FTC’s privacy program page at
www.ftc.gov/privacy and at 73 FR
33592, 33634 (June 12, 2008).
Jkt 241001
Records contained in this system that
have been placed on the FTC public
record are available upon request, as
discussed above. However, pursuant to
5 U.S.C. 552a(k)(2), records in this
system, which reflect records that are
contained in other systems of records
that are designated as exempt, are
exempt from the requirements of
subsections (c)(3), (d), (e)(1), (e)(4)(G),
(H), (I), and (f) of 5 U.S.C. 552a. See
§ 4.13(m) of the FTC Rules of Practice,
16 CFR 4.13(m).
HISTORY:
*
POLICIES AND PRACTICES FOR RETENTION AND
DISPOSAL OF RECORDS:
14:10 Jun 14, 2017
See § 4.13 of the FTC’s Rules of
Practice, 16 CFR 4.13. For additional
guidance, see also Appendix II (How To
Make A Privacy Act Request), available
on the FTC’s privacy program page at
www.ftc.gov/privacy and at 73 FR
33592, 33634 (June 12, 2008).
EXEMPTIONS PROMULGATED FOR THE SYSTEM:
Records are maintained electronically
using a commercial software application
run on the agency’s internal servers.
Temporary paper files are destroyed
once the request is complete.
VerDate Sep<11>2014
NOTIFICATION PROCEDURES:
73 FR 33592–33634 (June 12, 2008).
*
*
*
*
David C. Shonka,
Acting General Counsel.
[FR Doc. 2017–12452 Filed 6–14–17; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0192]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Establishing and
Maintaining Lists of U.S. Milk Product
Manufacturers/Processors With
Interest in Exporting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, we, or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (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 the information
collection entitled ‘‘Establishing and
Maintaining Lists of U.S. Milk Product
Manufacturers/Processors With Interest
SUMMARY:
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
27485
in Exporting,’’ which establishes and
maintains lists of U.S. milk product
manufacturers and processors with
interest in exporting to countries that
require such lists to be maintained. The
notice also solicits comments on an
electronic registry that will allow
manufacturers and processors of milk
products to electronically request
inclusion on the export lists.
DATES: Submit either electronic or
written comments on the collection of
information by August 14, 2017.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before August 14,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of August 14, 2017.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
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.
E:\FR\FM\15JNN1.SGM
15JNN1
pmangrum on DSK3GDR082PROD with NOTICES
27486
Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices
• 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–
2014–N–0192 for ‘‘Establishing and
Maintaining Lists of U.S. Milk Product
Manufacturers/Processors with Interest
in Exporting.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
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
VerDate Sep<11>2014
14:10 Jun 14, 2017
Jkt 241001
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A63, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794.
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.
Establishing and Maintaining Lists of
U.S. Milk Product Manufacturers/
Processors With Interest in Exporting—
21 U.S.C. 371—OMB Control Number
0910–0509—Extension
The United States exports a large
volume and variety of foods in
international trade. For certain food
products, foreign governments may
require assurances from the responsible
authority of the country of origin of an
imported food that the processor of the
food is in compliance with applicable
country of origin regulatory
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
requirements. With regard to U.S. milk
products, FDA is the competent U.S.
food safety authority to provide this
information to foreign governments.
FDA provides the requested information
about processors in the form of lists,
which are provided to the foreign
governments and posted online at
https://www.fda.gov/Food/
GuidanceRegulation/ImportsExports/
Exporting/default.htm.
Currently, FDA provides Chile, China,
and the European Union (EU) with a list
of U.S. milk product manufacturers/
processors that: (1) Have expressed
interest in exporting their products to
these countries; (2) are subject to FDA’s
jurisdiction; and (3) are not the subject
of a pending enforcement action (i.e., an
injunction or seizure or a pending
warning letter).
FDA has published guidance
documents for these countries under the
authority of section 701(h) of the
Federal, Food, Drug, and Cosmetic Act
(21 U.S.C. 371(h)), which authorizes the
Secretary of Health and Human Services
(the Secretary) to develop guidance
documents with public participation
presenting the views of the Secretary on
matters under the jurisdiction of FDA.
The guidance documents explain
what information manufacturers/
processors should submit to FDA to be
considered for inclusion on the lists and
what criteria FDA intends to use to
determine eligibility for placement on
the lists. The guidance documents also
explain how FDA intends to update the
list and communicate any new
information to the government that
requested the list. Finally, the guidance
documents note that the information is
provided voluntarily by manufacturers/
processors with the understanding that
it will be posted on FDA’s external Web
site and communicated to, and possibly
further disseminated by, the government
that requested the list; thus, FDA
considers the information on the lists to
be information that is not protected
from disclosure under 5 U.S.C.
552(b)(4).
Application for inclusion on each list
is voluntary. However, some foreign
governments may require inclusion on
the list for acceptance of imported food.
FDA recommends that U.S.
manufacturers/processors that want to
be placed on the export lists send FDA
the following information: (1) Country
to which the milk manufacturer/
processor wants to export product; (2)
type of milk product facility; (3) the
Food Facility Registration Module
number (the information collected by
this module is approved under OMB
control number 0910–0502); (4) name
and address of the firm and the
E:\FR\FM\15JNN1.SGM
15JNN1
Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices
manufacturing plant; (5) name,
telephone number, and email address of
the contact person; (6) list of products
divided into three categories: Presently
shipped, ready to ship, and available for
shipment in the next 3 years; (7)
identities of agencies that inspected the
plant; (8) date of last inspection, plant
number, and copy of last inspection
notice; and (9) if other than an FDA
inspection, copy of last inspection
report.
We request that this information be
updated every 2 years.
We use the information submitted by
firms to determine their eligibility for
placement on the export lists, which are
published on our Web site. The purpose
of the lists is to help foreign
governments in their determinations of
which U.S. milk product manufacturers
and processors are eligible to export to
their respective countries.
FDA has recently developed an
electronic registry system (Form FDA
3972) that allows milk product
manufacturers and processors to
electronically send a request to FDA to
be included on the export lists.
Manufacturers and processors that
prefer to submit a paper request in a
format of their own choosing will still
have the option to do so. Electronic
Form FDA 3972 collects the same
27487
information as is currently collected via
the existing paper-based process. Draft
screenshots of Form FDA 3972 and
instructions are available at https://
www.fda.gov/Food/
GuidanceRegulation/ImportsExports/
Exporting/ucm496929.htm and is
entitled ‘‘Dairy Listing Module.’’
Description of Respondents:
Respondents to this collection of
information include U.S. milk product
manufacturers/processors subject to
FDA jurisdiction that wish to export to
certain foreign countries that require
inclusion on export lists.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
New requests to be placed on the lists ...................
Biennial update ........................................................
Occasional updates .................................................
2,000
2,000
200
1
1
1
2,000
2,000
200
1 ................................
0.5 (30 minutes) ........
0.5 (30 minutes) ........
2,000
1,000
100
Total ..................................................................
........................
........................
........................
....................................
3,100
pmangrum on DSK3GDR082PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA bases its estimate on the number
of manufacturers/processors that have
submitted new written requests,
biennial updates, and occasional
updates over the past 10 years. The
estimate of the number of burden hours
it will take a manufacturer/processor to
gather the information needed to be
placed on the list or update its
information is based on FDA’s
experience with manufacturers/
processors submitting similar requests.
FDA believes that the information to be
submitted will be readily available to
manufacturers/processors. This
collection is also incorporating
information collected to maintain lists
of eligible exporters of dairy products
who wish to export to the EU from OMB
control number 0910–0320, ‘‘Request for
Information from U.S. Processors that
Export to the European Community.’’
FDA estimates that 2,000 firms will
average 60 minutes (1 hour) to submit
new requests for inclusion on the list,
2,000 firms will average 30 minutes (0.5
hour) to update their information every
2 years, and 200 firms will average 30
minutes (0.5 hour) to occasionally
update their information in this system.
We also believe that submission via the
electronic registry system will not affect
the burden estimates. An electronic
registry will enhance the ability of firms
to more efficiently request inclusion on
export lists. FDA calculates, therefore,
that the total burden for this collection
VerDate Sep<11>2014
14:10 Jun 14, 2017
Jkt 241001
is 3,100 hours ((2,000 × 1) plus (2,000
× 0.5) plus (200 × 0.5)).
submitted by Philip Morris Products
S.A.
Dated: June 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
DATES:
[FR Doc. 2017–12356 Filed 6–14–17; 8:45 am]
BILLING CODE 4164–01–P
Electronic Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–3001]
Modified Risk Tobacco Product
Applications: Applications for IQOS
System With Marlboro Heatsticks,
IQOS System With Marlboro Smooth
Menthol Heatsticks, and IQOS System
With Marlboro Fresh Menthol
Heatsticks Submitted by Philip Morris
Products S.A.; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability for public
comment of modified risk tobacco
product applications (MRTPAs) for
IQOS system with Marlboro Heatsticks,
IQOS system with Marlboro Smooth
Menthol Heatsticks, and IQOS system
with Marlboro Fresh Menthol Heatsticks
SUMMARY:
PO 00000
Frm 00026
Fmt 4703
Submit either electronic or
written comments on the application by
December 12, 2017.
ADDRESSES: You may submit comments
as follows:
Sfmt 4703
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
E:\FR\FM\15JNN1.SGM
15JNN1
]]>Agencies
[Federal Register Volume 82, Number 114 (Thursday, June 15, 2017)]
[Notices]
[Pages 27485-27487]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12356]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0192]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Establishing and Maintaining Lists of U.S. Milk
Product Manufacturers/Processors With Interest in Exporting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (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 the information collection
entitled ``Establishing and Maintaining Lists of U.S. Milk Product
Manufacturers/Processors With Interest in Exporting,'' which
establishes and maintains lists of U.S. milk product manufacturers and
processors with interest in exporting to countries that require such
lists to be maintained. The notice also solicits comments on an
electronic registry that will allow manufacturers and processors of
milk products to electronically request inclusion on the export lists.
DATES: Submit either electronic or written comments on the collection
of information by August 14, 2017.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before August 14, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of August 14, 2017. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
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.
[[Page 27486]]
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-2014-N-0192 for ``Establishing and Maintaining Lists of U.S. Milk
Product Manufacturers/Processors with Interest in Exporting.'' Received
comments, those filed in a timely manner (see ADDRESSES), 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
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: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North,
10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794.
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.
Establishing and Maintaining Lists of U.S. Milk Product Manufacturers/
Processors With Interest in Exporting--21 U.S.C. 371--OMB Control
Number 0910-0509--Extension
The United States exports a large volume and variety of foods in
international trade. For certain food products, foreign governments may
require assurances from the responsible authority of the country of
origin of an imported food that the processor of the food is in
compliance with applicable country of origin regulatory requirements.
With regard to U.S. milk products, FDA is the competent U.S. food
safety authority to provide this information to foreign governments.
FDA provides the requested information about processors in the form of
lists, which are provided to the foreign governments and posted online
at https://www.fda.gov/Food/GuidanceRegulation/ImportsExports/Exporting/default.htm.
Currently, FDA provides Chile, China, and the European Union (EU)
with a list of U.S. milk product manufacturers/processors that: (1)
Have expressed interest in exporting their products to these countries;
(2) are subject to FDA's jurisdiction; and (3) are not the subject of a
pending enforcement action (i.e., an injunction or seizure or a pending
warning letter).
FDA has published guidance documents for these countries under the
authority of section 701(h) of the Federal, Food, Drug, and Cosmetic
Act (21 U.S.C. 371(h)), which authorizes the Secretary of Health and
Human Services (the Secretary) to develop guidance documents with
public participation presenting the views of the Secretary on matters
under the jurisdiction of FDA.
The guidance documents explain what information manufacturers/
processors should submit to FDA to be considered for inclusion on the
lists and what criteria FDA intends to use to determine eligibility for
placement on the lists. The guidance documents also explain how FDA
intends to update the list and communicate any new information to the
government that requested the list. Finally, the guidance documents
note that the information is provided voluntarily by manufacturers/
processors with the understanding that it will be posted on FDA's
external Web site and communicated to, and possibly further
disseminated by, the government that requested the list; thus, FDA
considers the information on the lists to be information that is not
protected from disclosure under 5 U.S.C. 552(b)(4).
Application for inclusion on each list is voluntary. However, some
foreign governments may require inclusion on the list for acceptance of
imported food. FDA recommends that U.S. manufacturers/processors that
want to be placed on the export lists send FDA the following
information: (1) Country to which the milk manufacturer/processor wants
to export product; (2) type of milk product facility; (3) the Food
Facility Registration Module number (the information collected by this
module is approved under OMB control number 0910-0502); (4) name and
address of the firm and the
[[Page 27487]]
manufacturing plant; (5) name, telephone number, and email address of
the contact person; (6) list of products divided into three categories:
Presently shipped, ready to ship, and available for shipment in the
next 3 years; (7) identities of agencies that inspected the plant; (8)
date of last inspection, plant number, and copy of last inspection
notice; and (9) if other than an FDA inspection, copy of last
inspection report.
We request that this information be updated every 2 years.
We use the information submitted by firms to determine their
eligibility for placement on the export lists, which are published on
our Web site. The purpose of the lists is to help foreign governments
in their determinations of which U.S. milk product manufacturers and
processors are eligible to export to their respective countries.
FDA has recently developed an electronic registry system (Form FDA
3972) that allows milk product manufacturers and processors to
electronically send a request to FDA to be included on the export
lists. Manufacturers and processors that prefer to submit a paper
request in a format of their own choosing will still have the option to
do so. Electronic Form FDA 3972 collects the same information as is
currently collected via the existing paper-based process. Draft
screenshots of Form FDA 3972 and instructions are available at https://www.fda.gov/Food/GuidanceRegulation/ImportsExports/Exporting/ucm496929.htm and is entitled ``Dairy Listing Module.''
Description of Respondents: Respondents to this collection of
information include U.S. milk product manufacturers/processors subject
to FDA jurisdiction that wish to export to certain foreign countries
that require inclusion on export lists.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
New requests to be placed on the lists...... 2,000 1 2,000 1......................................... 2,000
Biennial update............................. 2,000 1 2,000 0.5 (30 minutes).......................... 1,000
Occasional updates.......................... 200 1 200 0.5 (30 minutes).......................... 100
-----------------------------------------------------------------------------------------------------------
Total................................... .............. .............. .............. .......................................... 3,100
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA bases its estimate on the number of manufacturers/processors
that have submitted new written requests, biennial updates, and
occasional updates over the past 10 years. The estimate of the number
of burden hours it will take a manufacturer/processor to gather the
information needed to be placed on the list or update its information
is based on FDA's experience with manufacturers/processors submitting
similar requests. FDA believes that the information to be submitted
will be readily available to manufacturers/processors. This collection
is also incorporating information collected to maintain lists of
eligible exporters of dairy products who wish to export to the EU from
OMB control number 0910-0320, ``Request for Information from U.S.
Processors that Export to the European Community.''
FDA estimates that 2,000 firms will average 60 minutes (1 hour) to
submit new requests for inclusion on the list, 2,000 firms will average
30 minutes (0.5 hour) to update their information every 2 years, and
200 firms will average 30 minutes (0.5 hour) to occasionally update
their information in this system. We also believe that submission via
the electronic registry system will not affect the burden estimates. An
electronic registry will enhance the ability of firms to more
efficiently request inclusion on export lists. FDA calculates,
therefore, that the total burden for this collection is 3,100 hours
((2,000 x 1) plus (2,000 x 0.5) plus (200 x 0.5)).
Dated: June 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12356 Filed 6-14-17; 8:45 am]
BILLING CODE 4164-01-P
