Agency Information Collection Activities; Proposed Collection; Comment Request; Establishing and Maintaining Lists of U.S. Manufacturers/Processors With Interest in Exporting Center for Food Safety and Applied Nutrition-Regulated Products, 56350-56353 [2018-24618]
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Federal Register / Vol. 83, No. 219 / Tuesday, November 13, 2018 / Notices
comment on the proposed collection of
information. No comments were
received.
The number of commercial INDs with
activity is approximately 4,000 per year.
ERG will interview 1 to 3 sponsor
representatives at a time for up to 150
INDs during the annual assessment
period.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Type of respondent
Total annual
responses
Average burden
per response
Total hours
IND sponsors: Surveys ................................................
IND sponsors: Interviews ............................................
150
450
1
1
150
450
0.17 (10 minutes) ..
1.5 ..........................
25.50
675
Total ......................................................................
........................
........................
........................
................................
700.50
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA estimates that it will take each
IND sponsor a maximum of 10 minutes
to complete a survey. Up to 150
respondents will take part in the survey,
yielding a maximum burden of 25.5
hours. FDA estimates that it will take
each IND sponsor up to 90 minutes to
respond to requests for interviews and
participate in interviews. Up to 450
respondents will take part in interviews,
yielding a maximum burden of 675
hours. FDA’s burden estimates are based
on experience with information
collections for similar types of PDUFArelated assessments.
Dated: November 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–24608 Filed 11–9–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–4042]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Establishing and
Maintaining Lists of U.S.
Manufacturers/Processors With
Interest in Exporting Center for Food
Safety and Applied Nutrition-Regulated
Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA 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,
SUMMARY:
amozie on DSK3GDR082PROD with NOTICES1
Number of
responses per
respondent
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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 collection of
information that FDA uses to establish
and maintain lists of U.S. manufacturers
and processors with an interest in
exporting products regulated by the
Center for Food Safety and Applied
Nutrition (CFSAN) to countries that
require such lists to be maintained. The
notice also solicits comments on
changes to the electronic registry that
will allow manufacturers and processors
of CFSAN-regulated products to
electronically request inclusion on the
export lists.
DATES: Submit either electronic or
written comments on the collection of
information by January 14, 2019.
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 January 14,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of January 14, 2019.
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
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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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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–
2018–N–4042 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Establishing and Maintaining Lists of
Manufacturers/Processors With Interest
in Exporting CFSAN-regulated
Products.’’ 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 Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
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Federal Register / Vol. 83, No. 219 / Tuesday, November 13, 2018 / Notices
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 Dockets Management
Staff. 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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, 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
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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. Manufacturers/Processors With
Interest in Exporting CFSAN-Regulated
Products
OMB Control Number 0910–0509—
Revision
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. Some foreign
governments establish additional
requirements with which exporters are
required to comply and ask for
additional assurances from the
responsible authority. When requested,
FDA may provide this information in
the form of lists which are provided to
the foreign governments.
For products subject to importing
country listing requirements, FDA has
historically maintained certain export
lists of 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 (e.g., an injunction
or seizure) or pending administrative
action (e.g., a warning letter).
FDA has generally published
guidance documents for these lists
under the authority of section 701(h) of
the Federal, Food, Drug, and Cosmetic
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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 generally
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 lists and
communicate any new information to
the governments that requested the lists.
Finally, the guidance documents note
that the information is provided
voluntarily by manufacturers/processors
with the understanding that it may be
posted on FDA’s external website and
that it will be 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
products. 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 food manufacturer/
processor wants to export product; (2)
type of food product facility; (3) the
Food Facility Registration number (the
information collected by this module is
approved under OMB control number
0910–0502), FDA Establishment
Identifier number, or Dun & Bradstreet
number for the facility; (4) name and
address of the firm and the
manufacturing plant; (5) name,
telephone number, and email address of
the contact person; (6) information on
the products intended for export; (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.
In addition to the information above,
some countries may require additional
information such as documentation that
the firm has been certified by a thirdparty certification body that it meets the
requirements of the importing country.
Other information may need to be
submitted to be included on the lists
depending on the requirements of the
importing country. FDA plans to
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provide exporters with information
about any such additional information
required by a foreign country as a
condition for entry and collect the other
information to accommodate the
importing countries’ requirements.
We use the information submitted by
firms to determine their eligibility for
placement on the export lists, which
may be published on our website. The
purpose of the lists is to help CFSANregulated industries meet the import
requirements of foreign governments.
FDA currently maintains export lists
for the European Community and China
covered under OMB control numbers
0910–0320 and 0910–0839, respectively.
These export lists also serve to assist
firms to meet the import requirements of
foreign governments. OMB control
numbers 0910–0509, 0910–0320, and
0910–0839 are very similar in that they
allow FDA to collect information from
firms for the purpose of establishing
export lists for foreign governments that
require these lists before allowing the
subject goods to be imported. Thus,
with this notice, FDA proposes to
consolidate these collections of
information for government efficiency
and to allow the public to look to one
OMB control number for all collections
of information for CFSAN export lists.
This collection of information is
intended to cover all of CFSAN’s
existing export lists, as well as any
additional export lists required by
foreign countries.
In 2016, FDA launched the Dairy
Listing Module, an electronic registry
system (Form FDA 3972) to facilitate
applications for inclusion on the dairy
export lists. FDA has expanded this
system to accommodate applications for
inclusion on export lists for CFSANregulated products, affording all firms
the efficiencies of submitting
information electronically. The
expanded system is called the Export
Listing Module (ELM). The ELM has
data fields that allow firms to input the
information identified above that FDA
recommends providing. In addition, the
ELM contains data fields such as
‘‘Additional Information’’ and
‘‘Additional Documents’’ that allow
firms to submit any additional data or
information (such as third-party
certifications) that foreign governments
may require. Screenshots of the ELM are
available at https://www.fda.gov/Food/
GuidanceRegulation/ImportsExports/
Exporting/ucm496929.htm. If a firm is
unable to submit an application via the
ELM, it may contact CFSAN and request
assistance.
Description of Respondents:
Respondents to this collection of
information include U.S.
manufacturers/processors subject to
FDA/CFSAN 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
Total annual
responses
New requests to be placed on the lists ...................
Third-party certification ............................................
Biennial update ........................................................
Third-party certification biennial update ...................
Occasional updates .................................................
1,460
370
2,505
555
300
1
1
1
1
1
1,460
370
2,505
555
300
Total ..................................................................
........................
........................
........................
1 There
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Number of
responses per
respondent
Average burden per
response
0.5
21
0.5
21
0.5
Total hours
(30 minutes) ........
..............................
(30 minutes) ........
..............................
(30 minutes) ........
730
7,770
1,253
11,655
150
....................................
21,558
are no capital costs or operating and maintenance costs associated with this collection of information.
The information collection reflects an
increase in burden by 18,458 hours due
to the consolidation of the information
collections covered by OMB control
numbers 0910–0839 and 0910–0320.
Also, our current estimate of the number
of foreign countries that may require us
to establish lists in the next 3 years and
the type of information they may require
us to collect in order to maintain such
lists has also resulted in an increase. At
the same time, we have developed an
electronic reporting portal that is
expected to reduce the overall reporting
time per submission. The portal will
enhance the ability of firms to more
efficiently request inclusion on export
lists.
We base our 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
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information is based on our experience
with manufacturers/processors
submitting similar requests. We believe
that the information to be submitted
will be readily available to
manufacturers/processors. This
collection is incorporating additional
information collected to maintain lists
of eligible exporters of CFSAN-regulated
products who wish to export to foreign
markets, including the European Union,
Chile and China under OMB control
numbers 0910–0320, ‘‘Request for
Information from U.S. Processors that
Export to the European Community’’
and 0910–0839, ‘‘Establishing and
Maintaining Lists of U.S.
Manufacturers/Processors with Interest
in Exporting CFSAN-Regulated Products
to China. ’’
We estimate that 1,460 firms will
average 30 minutes (0.5 hour) to submit
new requests for inclusion on the list,
2,505 firms will average 30 minutes (0.5
hour) to update their information every
2 years, and 300 firms will average 30
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minutes (0.5 hour) to occasionally
update their information in this system.
Some firms will need to provide
documentation that they obtained thirdparty certification to certify that they
have met the requirements of the
importing country. Currently, only
China has this requirement. Based on
our experience with this program, 370
firms will spend about 21 hours to
complete the third-party certification for
a total of 7,770 burden hours. During the
biennial update, we estimate that about
half of the 1,110 manufacturers/
processors for which the importing
country requires third-party certification
will be recertified, meaning that 555
manufacturers/processors (1110
manufacturers/processors × 0.5) will get
recertified each year. We estimate that it
will take each such manufacturer/
processor about 21 hours to complete
the certification process for a total of
11,655 burden hours (555
manufacturers/processors × 21 hours).
We calculate, therefore, that the total
burden for this collection is 21,558
hours.
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Federal Register / Vol. 83, No. 219 / Tuesday, November 13, 2018 / Notices
Dated: November 2, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–24618 Filed 11–9–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Maternal and
Child Health Bureau Performance
Measures for Discretionary Grant
Information System (DGIS), OMB No.
0915–0298—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995 for opportunity
for public comment on proposed data
collection projects, HRSA announces
plans to submit an Information
Collection Request (ICR), described
below, to the Office of Management and
Budget (OMB). Prior to submitting the
ICR to OMB, HRSA seeks comments
from the public regarding the burden
estimate, below, or any other aspect of
the ICR.
DATES: Comments on this ICR must be
received no later than January 14, 2019.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Maternal and Child Health Bureau
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SUMMARY:
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Performance Measures for Discretionary
Grant Information System (DGIS), OMB
No. 0915–0298—Revision
Abstract: This Information Collection
Request is for continued approval of
performance measures for HRSA’s
Maternal and Child Health Bureau
(MCHB) discretionary grants,
specifically, the continued use of
reporting requirements for grant
programs administered by MCHB in
accordance with the ‘‘Government
Performance and Results Act of 1993’’
(Pub. L. 103–62). This Act requires the
preparation of an annual performance
plan covering each program activity set
forth in the agency’s budget, which
includes establishment of measurable
goals that may be reported in an annual
financial statement to support the
linkage of funding decisions with
performance. Performance measures for
MCHB discretionary grants were
initially approved in 2003, and the
latest approval was obtained in 2016 for
significant revisions. Continued
approval from OMB is currently being
sought to continue the use of
performance measures with minor
revisions. Most of these measures are
specific to certain types of programs and
are not required of all grantees. The
measures are categorized by domains
(Adolescent Health, Capacity Building,
Child Health, Children with Special
Health Care Needs, Lifecourse/
Crosscutting, Maternal/Women Health,
and Perinatal/Infant Health). In
addition, there are some programspecific measures. Grant programs are
assigned domains based on their
activities. HRSA is proposing to make
changes to the DGIS to more closely
align data collection forms with current
program activities. These revisions will
facilitate more accurate reporting of
descriptive information related to Longterm Trainees in Maternal and Child
Health, as well as activities related to
Technical Assistance for programs.
Proposed changes include the following:
• Trainee Information (Long-term
Trainees Only) form:
Æ Changes will incorporate options
and titles that were omitted from the
final submission of the previous OMB
package, providing clarification for the
reporting of specific descriptive
information about Long-term Trainees
on the form.
Æ Changes will list the following
options for ‘‘Type’’: ‘‘Non-Degree
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56353
Seeking,’’ ‘‘Undergraduate,’’ ‘‘Masters,’’
‘‘Doctoral,’’ Post-doctoral,’’ ‘‘Other.’’
Æ Changes will list the title ‘‘Student
Status’’ next to the options for ‘‘Parttime student’’ and ‘‘Full-time student.’’
• Technical Assistance/Collaboration
form:
Æ Add a field asking for the ‘‘Total
number of TA recipients.’’ This change
will allow for better alignment with this
data that was previously collected by
program, but omitted due to a DGIS
paper form error.
Æ Add an ‘‘Other’’ category to List B
under ‘‘Topic of Technical Assistance/
Collaboration.’’ This change would
facilitate more accurate data reporting
by providing programs an additional
category to choose from if their current
Technical Assistance activities do not
closely align with the existing categories
in List B.
Need and Proposed Use of the
Information: The performance data
collected through the DGIS serves
several purposes, including grantee
monitoring, program planning,
performance reporting, and the ability to
demonstrate alignment between MCHB
discretionary programs and the Title V
MCH Services Block Grant program.
This revision will facilitate more
accurate reporting of descriptive
information related to Long-term
Trainees in Maternal and Child Health,
as well as activities related to Technical
Assistance for programs.
Likely Respondents: The grantees for
Maternal and Child Health Bureau
Discretionary Grant Programs.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
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]]>Agencies
[Federal Register Volume 83, Number 219 (Tuesday, November 13, 2018)]
[Notices]
[Pages 56350-56353]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24618]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-4042]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Establishing and Maintaining Lists of U.S.
Manufacturers/Processors With Interest in Exporting Center for Food
Safety and Applied Nutrition-Regulated Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA 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 collection of information that FDA uses
to establish and maintain lists of U.S. manufacturers and processors
with an interest in exporting products regulated by the Center for Food
Safety and Applied Nutrition (CFSAN) to countries that require such
lists to be maintained. The notice also solicits comments on changes to
the electronic registry that will allow manufacturers and processors of
CFSAN-regulated products to electronically request inclusion on the
export lists.
DATES: Submit either electronic or written comments on the collection
of information by January 14, 2019.
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 January 14, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 14, 2019. 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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-2018-N-4042 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Establishing and Maintaining
Lists of Manufacturers/Processors With Interest in Exporting CFSAN-
regulated Products.'' 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 Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential
[[Page 56351]]
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
Dockets Management Staff. 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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Establishing and Maintaining Lists of U.S. Manufacturers/Processors
With Interest in Exporting CFSAN-Regulated Products
OMB Control Number 0910-0509--Revision
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.
Some foreign governments establish additional requirements with which
exporters are required to comply and ask for additional assurances from
the responsible authority. When requested, FDA may provide this
information in the form of lists which are provided to the foreign
governments.
For products subject to importing country listing requirements, FDA
has historically maintained certain export lists of 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 (e.g., an
injunction or seizure) or pending administrative action (e.g., a
warning letter).
FDA has generally published guidance documents for these lists
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 generally 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 lists and
communicate any new information to the governments that requested the
lists. Finally, the guidance documents note that the information is
provided voluntarily by manufacturers/processors with the understanding
that it may be posted on FDA's external website and that it will be
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 products. 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 food manufacturer/processor wants
to export product; (2) type of food product facility; (3) the Food
Facility Registration number (the information collected by this module
is approved under OMB control number 0910-0502), FDA Establishment
Identifier number, or Dun & Bradstreet number for the facility; (4)
name and address of the firm and the manufacturing plant; (5) name,
telephone number, and email address of the contact person; (6)
information on the products intended for export; (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.
In addition to the information above, some countries may require
additional information such as documentation that the firm has been
certified by a third-party certification body that it meets the
requirements of the importing country. Other information may need to be
submitted to be included on the lists depending on the requirements of
the importing country. FDA plans to
[[Page 56352]]
provide exporters with information about any such additional
information required by a foreign country as a condition for entry and
collect the other information to accommodate the importing countries'
requirements.
We use the information submitted by firms to determine their
eligibility for placement on the export lists, which may be published
on our website. The purpose of the lists is to help CFSAN-regulated
industries meet the import requirements of foreign governments.
FDA currently maintains export lists for the European Community and
China covered under OMB control numbers 0910-0320 and 0910-0839,
respectively. These export lists also serve to assist firms to meet the
import requirements of foreign governments. OMB control numbers 0910-
0509, 0910-0320, and 0910-0839 are very similar in that they allow FDA
to collect information from firms for the purpose of establishing
export lists for foreign governments that require these lists before
allowing the subject goods to be imported. Thus, with this notice, FDA
proposes to consolidate these collections of information for government
efficiency and to allow the public to look to one OMB control number
for all collections of information for CFSAN export lists. This
collection of information is intended to cover all of CFSAN's existing
export lists, as well as any additional export lists required by
foreign countries.
In 2016, FDA launched the Dairy Listing Module, an electronic
registry system (Form FDA 3972) to facilitate applications for
inclusion on the dairy export lists. FDA has expanded this system to
accommodate applications for inclusion on export lists for CFSAN-
regulated products, affording all firms the efficiencies of submitting
information electronically. The expanded system is called the Export
Listing Module (ELM). The ELM has data fields that allow firms to input
the information identified above that FDA recommends providing. In
addition, the ELM contains data fields such as ``Additional
Information'' and ``Additional Documents'' that allow firms to submit
any additional data or information (such as third-party certifications)
that foreign governments may require. Screenshots of the ELM are
available at https://www.fda.gov/Food/GuidanceRegulation/ImportsExports/Exporting/ucm496929.htm. If a firm is unable to submit
an application via the ELM, it may contact CFSAN and request
assistance.
Description of Respondents: Respondents to this collection of
information include U.S. manufacturers/processors subject to FDA/CFSAN
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...... 1,460 1 1,460 0.5 (30 minutes).......................... 730
Third-party certification................... 370 1 370 21........................................ 7,770
Biennial update............................. 2,505 1 2,505 0.5 (30 minutes).......................... 1,253
Third-party certification biennial update... 555 1 555 21........................................ 11,655
Occasional updates.......................... 300 1 300 0.5 (30 minutes).......................... 150
-----------------------------------------------------------------------------------------------------------
Total................................... .............. .............. .............. .......................................... 21,558
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The information collection reflects an increase in burden by 18,458
hours due to the consolidation of the information collections covered
by OMB control numbers 0910-0839 and 0910-0320. Also, our current
estimate of the number of foreign countries that may require us to
establish lists in the next 3 years and the type of information they
may require us to collect in order to maintain such lists has also
resulted in an increase. At the same time, we have developed an
electronic reporting portal that is expected to reduce the overall
reporting time per submission. The portal will enhance the ability of
firms to more efficiently request inclusion on export lists.
We base our 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
our experience with manufacturers/processors submitting similar
requests. We believe that the information to be submitted will be
readily available to manufacturers/processors. This collection is
incorporating additional information collected to maintain lists of
eligible exporters of CFSAN-regulated products who wish to export to
foreign markets, including the European Union, Chile and China under
OMB control numbers 0910-0320, ``Request for Information from U.S.
Processors that Export to the European Community'' and 0910-0839,
``Establishing and Maintaining Lists of U.S. Manufacturers/Processors
with Interest in Exporting CFSAN-Regulated Products to China. ''
We estimate that 1,460 firms will average 30 minutes (0.5 hour) to
submit new requests for inclusion on the list, 2,505 firms will average
30 minutes (0.5 hour) to update their information every 2 years, and
300 firms will average 30 minutes (0.5 hour) to occasionally update
their information in this system.
Some firms will need to provide documentation that they obtained
third-party certification to certify that they have met the
requirements of the importing country. Currently, only China has this
requirement. Based on our experience with this program, 370 firms will
spend about 21 hours to complete the third-party certification for a
total of 7,770 burden hours. During the biennial update, we estimate
that about half of the 1,110 manufacturers/processors for which the
importing country requires third-party certification will be
recertified, meaning that 555 manufacturers/processors (1110
manufacturers/processors x 0.5) will get recertified each year. We
estimate that it will take each such manufacturer/processor about 21
hours to complete the certification process for a total of 11,655
burden hours (555 manufacturers/processors x 21 hours).
We calculate, therefore, that the total burden for this collection
is 21,558 hours.
[[Page 56353]]
Dated: November 2, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24618 Filed 11-9-18; 8:45 am]
BILLING CODE 4164-01-P
