Agency Information Collection Activities; Proposed Collection; Comment Request; Establishing and Maintaining Lists of United States Manufacturers/Processors With Interest in Exporting Center for Food Safety and Applied Nutrition-Regulated Products to China, 43761-43764 [2017-19890]
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Federal Register / Vol. 82, No. 180 / Tuesday, September 19, 2017 / Notices
and toolkits for LHDs and community
groups so that they can align their
efforts and strengthen the benefits and
positive impacts of citizen science
activities. For interviews, the
information collection will target citizen
scientists and end users of citizen
science data.
Citizen science is defined as research
activities (e.g., data collection, analysis,
and reporting) performed by members of
the general public without any
particular training in science. Citizen
science is growing in popularity, fueled
in part by growing use of smartphones
and other personal devices in the
population. Although citizen collection
and use of data during disasters has
increased exponentially in recent years
and there is great policy interest in the
phenomenon, there has been no robust
research to date on the use of, barriers
to, and impact of citizen science in
disasters. Local health departments
(LHDs) lack tools to respond to and
coordinate with citizen science
activities within communities.
Furthermore, citizen science
organizations lack information on how
to organize their activities for ultimate
impact.
This is an exploratory study and is the
first of its kind to explore the growing
phenomenon of disaster citizen science.
Disaster citizen science is a rapidly
growing field that is the focus of policy
interest, but currently devoid of
research. This study will generate
information that can help define the
phenomenon of disaster citizen science
and may result in nationally
representative baseline data that can
support changes in citizen science
awareness, barriers, and activities.
While interviews will be hypothesis
generating and provide rich data on the
experiences with citizen science to date
across all stakeholders active in this
enterprise, the nationally-representative
survey data will allow us to generalize
findings to the full population of LHDs
in the U.S.
CDC will collaborate with a contractor
to implement this project. Researchers
will target citizen scientists and their
partners (e.g., academics who work with
citizen scientists on research projects)
and LHDs in a position to use citizen
science data to inform public health
decision-making. For interviews,
researchers will sample for maximum
variation, seeking to obtain variation on
U.S. region, type and sophistication of
citizen science project, type of disaster
encountered, and previous experience
with disaster citizen science.
The researchers aim to conduct 35–55
individual and group facilitated semistructured interviews, each lasting
approximately 60 minutes, to cover
topics including benefits and uses of
citizen science, barriers to and
facilitators of citizen science, and
strengths and limitations of citizen
science activities and resources.
Researchers will identify potential
interview participants through literature
reviews and snowball sampling in a
phased approach starting with citizen
science and LHD organizations.
Researchers will sample for maximum
variation in order to capture the full
range of citizen scientist and health
department experiences on this topic.
For the survey, the researchers will
target a nationally representative sample
of 600 local health officials and will
apply survey weights to ensure that
findings have external validity and can
be generalized to LHDs in the U.S. The
survey, which will take 30 minutes to
complete, will include questions on
both citizen science as applied to
disaster preparedness and response, and
citizen science as occurring in other
contexts (such as environmental
health)to draw lessons for preparedness
and response.
OPHPR anticipates that the
knowledge resulting from this research
project will contribute significantly to
the evidence base for preparedness and
response and lead to improved
efficiency, effectiveness, and outcomes
in several domains.
Participation in this study is
voluntary. There are no costs to
respondents other than their time. A
summary of annualized burden hours is
below.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses
per
respondent
Number of
respondents
Average
burden per
response
(in hours)
Total burden
(in hours)
Type of respondents
Form name
Citizen scientists and their partners;
local health officials.
Local health departments .................
Interview Guide (semi-structured
questionnaire).
Survey ..............................................
55
1
75/60
69
300
1
30/60
150
Total ...........................................
...........................................................
........................
........................
........................
219
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0192]
[FR Doc. 2017–19824 Filed 9–18–17; 8:45 am]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Establishing and
Maintaining Lists of United States
Manufacturers/Processors With
Interest in Exporting Center for Food
Safety and Applied Nutrition-Regulated
Products to China
asabaliauskas on DSKBBXCHB2PROD with NOTICES
BILLING CODE 4163–18–P
AGENCY:
Food and Drug Administration,
HHS.
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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,
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 provisions found in the
SUMMARY:
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guidance entitled ‘‘Establishing and
Maintaining a List of U.S. Milk and Milk
Product, Seafood, Infant Formula, and
Formula for Young Children
Manufacturers/Processors with Interest
in Exporting to China: Guidance for
Industry.’’
Submit either electronic or
written comments on the collection of
information by November 20, 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 November 20,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of November 20, 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.
DATES:
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’’).
asabaliauskas on DSKBBXCHB2PROD with NOTICES
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
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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–
2014–N–0192 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Establishing and Maintaining Lists of
U.S. Manufacturers/Processors with
Interest in Exporting CFSAN-Regulated
Products to China.’’ 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 Office
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 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
PO 00000
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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, 10A12M, 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
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 to China—21 U.S.C. 371
OMB Control Number 0910–0839—
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 product that the
manufacturer/processor of the food
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product is in compliance with
applicable country of origin regulatory
requirements. Some foreign
governments establish additional
requirements with which exporters are
required to comply.
In August 2011, China’s State General
Administration of the People’s Republic
of China for Quality Supervision,
Inspection, and Quarantine (AQSIQ)
published the ‘‘Administrative
Measures for Registration of Overseas
Manufacturers,’’ known as AQSIQ
Decree 145 (https://gain.fas.usda.gov/
Recent%20GAIN%20Publications/
Registration%20of%20Overseas%20
Food%20Manufacturing%20Facilities
%20_Beijing_China%20-%20
Peoples%20Republic%20of_6-272012.pdf), which became effective May
1, 2012. AQSIQ Decree 145, among
other requirements, mandates that
foreign competent authorities provide
the Certification and Accreditation
Administration of China (CNCA) with a
name list of overseas manufacturers of
imported food applying for registration
with CNCA for each commodity that
CNCA has deemed to require
registration. As of June 2017, milk and
milk products, seafood, infant formula,
and formula for young children are
among the commodities for which
CNCA requires registration of overseas
manufacturers under AQSIQ Decree
145. CNCA has recognized FDA/Center
for Food Safety and Applied Nutrition
(CFSAN) as the competent food safety
authority in the United States to
establish and maintain lists of U.S.
establishments that intend to export
U.S. milk and milk products, seafood,
infant formula, and/or formula for
young children to China, including the
corresponding products manufactured
by each establishment and intended for
export to China. In order to implement
AQSIQ Decree 145, FDA and CNCA
entered into a Memorandum of
Understanding (China MOU) on June
15, 2017, which sets out the two
agencies’ intent to facilitate the
conditions under which U.S.
manufacturers/processors can export to
China milk and milk products, seafood,
infant formula, and/or formula for
young children.
Under the China MOU, FDA intends
to establish and maintain lists that
identify U.S. manufacturers/processors
that have expressed interest to FDA in
exporting milk and milk products,
seafood, infant formula, and/or formula
for young children to China; are subject
to our jurisdiction; and have been found
by FDA to be in good regulatory
standing with FDA, including a finding
by FDA that, during the most recent
facility inspection, the manufacturers/
processors have been found to be in
substantial compliance with all
applicable FDA regulations, including,
but not limited to, current good
manufacturing practice requirements for
the identified products for export to
China. Further, the China MOU
provides for FDA to receive evidence
that the manufacturer/processor has
been certified by a third-party
certification body—as acknowledged by
CNCA—to meet the relevant standards,
laws, and regulations of China for the
identified food products for export to
China. On June 28, 2017, FDA issued a
guidance document entitled,
‘‘Establishing and Maintaining a List of
U.S. Milk and Milk Product, Seafood,
Infant Formula, and Formula for Young
Children Manufacturers/Processors with
Interest in Exporting to China: Guidance
for Industry’’ which can be found at
https://www.fda.gov/Food/
GuidanceRegulation/
GuidanceDocumentsRegulatory
Information/ucm378777.htm. The
guidance informs industry of
information that FDA and CNCA will
collect to manage the listing of these
manufacturers/processors and foods for
export to China pursuant to AQSIQ
Decree 145 and the China MOU.
In accordance with 5 CFR 1320.13,
FDA requested emergency review and
approval of the collections of
information found in the guidance
document. The routine course of
approval would have delayed our ability
to collect the information from firms
and, thus, would have been disruptive
in our efforts to facilitate exports of food
in compliance with requirements
established by China in AQSIQ Decree
145. OMB granted the approval under
emergency clearance procedures on
June 27, 2017.
FDA uses the information submitted
by manufacturers/processors to consider
them for inclusion on FDA’s lists of
eligible manufacturers/processors that
may ship food products to China, which
we maintain. Updates to the FDA lists
are sent to CNCA, which publishes
quarterly its version of the information
in the FDA lists on China’s Web site
(https://english.cnca.gov.cn/). The
purpose of the lists is to assist China in
its determination of which U.S. milk
and milk product, seafood, infant
formula, or formula for young children
manufacturers/processors are eligible to
import these products into China under
applicable Chinese law. Currently FDA
maintains lists for milk and milk
product, seafood, infant formula, and
formula for young children but FDA
wants to be prepared if CNCA requires
listing of manufacturers/processors of
other CFSAN-regulated products in the
future. As such, the information
collection request is not limited to milk
and milk product, seafood, infant
formula, and formula for young children
but also may include other CFSANregulated products.
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
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New written requests to be placed on the lists ...................
Third-party certification ........................................................
Biennial update ....................................................................
Third-party certification biennial update ...............................
Occasional updates .............................................................
370
370
555
555
100
1
1
1
1
1
370
370
555
555
100
1
21
1
21
0.5
370
7,770
555
11,655
50
Total ..............................................................................
........................
........................
........................
........................
20,400
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden for this information
collection has not changed since the last
OMB approval. Based on our experience
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maintaining other export lists, we
estimate that, annually, an average of
370 new manufacturers/processors will
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submit written requests to be placed on
the China lists. The estimate of the
number of hours that it will take a
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Federal Register / Vol. 82, No. 180 / Tuesday, September 19, 2017 / Notices
manufacturer/processor to gather the
information needed to be placed on a
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. We estimate
that a firm will require 1 hour to read
the guidance, gather the information
needed, and prepare a communication
to FDA that contains the information
needed to request that the
manufacturer/processor be placed on a
list.
To be placed on a list, manufacturers/
processors should provide FDA with
evidence that they have obtained thirdparty certification from a CNCAacknowledged certifier that the
manufacturer/processor complies with
the standards, laws, and regulations of
China according to relevant
requirements specified in AQSIQ Decree
145. Based on our experience with other
certification programs, FDA estimates
that it will take each new manufacturer/
processor about 21 hours to complete
the third-party certification process for
a total of 7,770 burden hours (370
manufacturers/processors × 21 hours).
Under the guidance, every 2 years
each manufacturer/processor on the lists
must provide updated information in
order to remain on the lists. FDA
estimates that each year approximately
half of the manufacturers/processors on
the lists, or 555 manufacturers/
processors (1,110 manufacturers/
processors × 0.5 = 555), will resubmit
the information to remain on the lists.
We estimate that a manufacturer/
processor already on the lists will
require 1 hour to biennially update and
resubmit the information to FDA,
including time reviewing the
information and corresponding with
FDA, for a total of 555 hours.
During the biennial update,
manufacturers/processors also need to
be recertified by a third-party certifier to
remain on the lists. FDA estimates that
each year approximately half of the
manufacturers/processors on the lists,
555 manufacturers/processors (1,110
manufacturers/processors × 0.5 = 555),
will get recertified. We estimate that it
will take each manufacturer/processor
about 21 hours to complete the
certification process for a total of 11,655
burden hours (555 manufacturers/
processors × 21 hours).
FDA expects that, each year,
approximately 100 manufacturers/
processors will need to submit an
occasional update and each
manufacturer/processor will require 0.5
hours to prepare a communication to
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FDA reporting the change, for a total of
50 hours.
Dated: September 13, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–19890 Filed 9–18–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0932]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Experimental
Study on Warning Statements for
Cigarette Graphic Health Warnings
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
SUMMARY:
Fax written comments on the
collection of information by October 19,
2017.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–NEW and
title ‘‘Experimental Study on Warning
Statements for Cigarette Graphic Health
Warnings.’’ Also include the FDA
docket number found in brackets in the
heading of this document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Jonalynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A63, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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Experimental Study on Warning
Statements for Cigarette Graphic Health
Warnings
OMB Control Number 0910–NEW
The health risks associated with the
use of cigarettes can be significant and
far-reaching. In 2009, Congress enacted
the Tobacco Control Act (TCA) (Pub. L.
111–31), which amends the Federal
Food, Drug, and Cosmetic Act to grant
FDA authority to regulate the
manufacture, marketing, and
distribution of tobacco products to
protect the public health and to reduce
tobacco use by minors. Section 201 of
the Tobacco Control Act amends section
4 of the Federal Cigarette Labeling and
Advertising Act (FCLAA) (15 U.S.C.
1333) to require FDA to issue
‘‘regulations that require color graphics
depicting the negative health
consequences of smoking to accompany
the label statements specified in
subsection (a)(1).’’ Section 202(b) of the
Tobacco Control Act further amends
section 4 of the FCLAA by adding that
the Secretary, through notice and
comment rulemaking, may adjust the
‘‘text of any of the label requirements
. . . . if the Secretary finds that such a
change would promote greater public
understanding of the risks associated
with the use of tobacco products.’’
In the Federal Register of June 22,
2011 (76 FR 36628), FDA issued a final
rule entitled ‘‘Required Warnings for
Cigarette Packages and
Advertisements,’’ which specified nine
images to accompany new textual
warning statements for cigarettes.
Although the rule was scheduled to
become effective 15 months after it
issued, a panel of the U.S. Court of
Appeals of the District of Columbia
held, on August 24, 2012, that the rule
in its current form violated the First
Amendment. In a letter to Congress on
March 15, 2013, the Attorney General
reported FDA’s intention to undertake
research to support a new rulemaking
consistent with the Tobacco Control
Act. Preliminary research has been
underway since 2013. Informed by the
previous court decisions on this matter,
including on the First Amendment, the
next phase of the research includes the
study proposed here, which is an effort
by FDA to collect data concerning
revised textual warning statements for
use with new images as part of cigarette
graphic health warnings, and their
potential impact on public
understanding of the risks associated
with the use of cigarettes.
As currently proposed, this
Experimental Study on Warning
Statements for Cigarette Graphic Health
Warnings is a voluntary online
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]]>Agencies
[Federal Register Volume 82, Number 180 (Tuesday, September 19, 2017)]
[Notices]
[Pages 43761-43764]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19890]
-----------------------------------------------------------------------
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 United States
Manufacturers/Processors With Interest in Exporting Center for Food
Safety and Applied Nutrition-Regulated Products to China
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 information collection provisions found
in the
[[Page 43762]]
guidance entitled ``Establishing and Maintaining a List of U.S. Milk
and Milk Product, Seafood, Infant Formula, and Formula for Young
Children Manufacturers/Processors with Interest in Exporting to China:
Guidance for Industry.''
DATES: Submit either electronic or written comments on the collection
of information by November 20, 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 November 20, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of November 20, 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): 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-2014-N-0192 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Establishing and Maintaining
Lists of U.S. Manufacturers/Processors with Interest in Exporting
CFSAN-Regulated Products to China.'' 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 Office 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 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, 10A12M, 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 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 to China--21 U.S.C.
371
OMB Control Number 0910-0839--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 product that the manufacturer/processor of
the food
[[Page 43763]]
product is in compliance with applicable country of origin regulatory
requirements. Some foreign governments establish additional
requirements with which exporters are required to comply.
In August 2011, China's State General Administration of the
People's Republic of China for Quality Supervision, Inspection, and
Quarantine (AQSIQ) published the ``Administrative Measures for
Registration of Overseas Manufacturers,'' known as AQSIQ Decree 145
(https://gain.fas.usda.gov/Recent%20GAIN%20Publications/Registration%20of%20Overseas%20Food%20Manufacturing%20Facilities%20_Beijing_China%20-%20Peoples%20Republic%20of_6-27-2012.pdf), which became
effective May 1, 2012. AQSIQ Decree 145, among other requirements,
mandates that foreign competent authorities provide the Certification
and Accreditation Administration of China (CNCA) with a name list of
overseas manufacturers of imported food applying for registration with
CNCA for each commodity that CNCA has deemed to require registration.
As of June 2017, milk and milk products, seafood, infant formula, and
formula for young children are among the commodities for which CNCA
requires registration of overseas manufacturers under AQSIQ Decree 145.
CNCA has recognized FDA/Center for Food Safety and Applied Nutrition
(CFSAN) as the competent food safety authority in the United States to
establish and maintain lists of U.S. establishments that intend to
export U.S. milk and milk products, seafood, infant formula, and/or
formula for young children to China, including the corresponding
products manufactured by each establishment and intended for export to
China. In order to implement AQSIQ Decree 145, FDA and CNCA entered
into a Memorandum of Understanding (China MOU) on June 15, 2017, which
sets out the two agencies' intent to facilitate the conditions under
which U.S. manufacturers/processors can export to China milk and milk
products, seafood, infant formula, and/or formula for young children.
Under the China MOU, FDA intends to establish and maintain lists
that identify U.S. manufacturers/processors that have expressed
interest to FDA in exporting milk and milk products, seafood, infant
formula, and/or formula for young children to China; are subject to our
jurisdiction; and have been found by FDA to be in good regulatory
standing with FDA, including a finding by FDA that, during the most
recent facility inspection, the manufacturers/processors have been
found to be in substantial compliance with all applicable FDA
regulations, including, but not limited to, current good manufacturing
practice requirements for the identified products for export to China.
Further, the China MOU provides for FDA to receive evidence that the
manufacturer/processor has been certified by a third-party
certification body--as acknowledged by CNCA--to meet the relevant
standards, laws, and regulations of China for the identified food
products for export to China. On June 28, 2017, FDA issued a guidance
document entitled, ``Establishing and Maintaining a List of U.S. Milk
and Milk Product, Seafood, Infant Formula, and Formula for Young
Children Manufacturers/Processors with Interest in Exporting to China:
Guidance for Industry'' which can be found at https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm378777.htm. The guidance informs industry of information that FDA
and CNCA will collect to manage the listing of these manufacturers/
processors and foods for export to China pursuant to AQSIQ Decree 145
and the China MOU.
In accordance with 5 CFR 1320.13, FDA requested emergency review
and approval of the collections of information found in the guidance
document. The routine course of approval would have delayed our ability
to collect the information from firms and, thus, would have been
disruptive in our efforts to facilitate exports of food in compliance
with requirements established by China in AQSIQ Decree 145. OMB granted
the approval under emergency clearance procedures on June 27, 2017.
FDA uses the information submitted by manufacturers/processors to
consider them for inclusion on FDA's lists of eligible manufacturers/
processors that may ship food products to China, which we maintain.
Updates to the FDA lists are sent to CNCA, which publishes quarterly
its version of the information in the FDA lists on China's Web site
(https://english.cnca.gov.cn/). The purpose of the lists is to assist
China in its determination of which U.S. milk and milk product,
seafood, infant formula, or formula for young children manufacturers/
processors are eligible to import these products into China under
applicable Chinese law. Currently FDA maintains lists for milk and milk
product, seafood, infant formula, and formula for young children but
FDA wants to be prepared if CNCA requires listing of manufacturers/
processors of other CFSAN-regulated products in the future. As such,
the information collection request is not limited to milk and milk
product, seafood, infant formula, and formula for young children but
also may include other CFSAN-regulated products.
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 Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
New written requests to be 370 1 370 1 370
placed on the lists............
Third-party certification....... 370 1 370 21 7,770
Biennial update................. 555 1 555 1 555
Third-party certification 555 1 555 21 11,655
biennial update................
Occasional updates.............. 100 1 100 0.5 50
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 20,400
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The burden for this information collection has not changed since
the last OMB approval. Based on our experience maintaining other export
lists, we estimate that, annually, an average of 370 new manufacturers/
processors will submit written requests to be placed on the China
lists. The estimate of the number of hours that it will take a
[[Page 43764]]
manufacturer/processor to gather the information needed to be placed on
a 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. We estimate that a firm will require 1 hour
to read the guidance, gather the information needed, and prepare a
communication to FDA that contains the information needed to request
that the manufacturer/processor be placed on a list.
To be placed on a list, manufacturers/processors should provide FDA
with evidence that they have obtained third-party certification from a
CNCA-acknowledged certifier that the manufacturer/processor complies
with the standards, laws, and regulations of China according to
relevant requirements specified in AQSIQ Decree 145. Based on our
experience with other certification programs, FDA estimates that it
will take each new manufacturer/processor about 21 hours to complete
the third-party certification process for a total of 7,770 burden hours
(370 manufacturers/processors x 21 hours).
Under the guidance, every 2 years each manufacturer/processor on
the lists must provide updated information in order to remain on the
lists. FDA estimates that each year approximately half of the
manufacturers/processors on the lists, or 555 manufacturers/processors
(1,110 manufacturers/processors x 0.5 = 555), will resubmit the
information to remain on the lists. We estimate that a manufacturer/
processor already on the lists will require 1 hour to biennially update
and resubmit the information to FDA, including time reviewing the
information and corresponding with FDA, for a total of 555 hours.
During the biennial update, manufacturers/processors also need to
be recertified by a third-party certifier to remain on the lists. FDA
estimates that each year approximately half of the manufacturers/
processors on the lists, 555 manufacturers/processors (1,110
manufacturers/processors x 0.5 = 555), will get recertified. We
estimate that it will take each manufacturer/processor about 21 hours
to complete the certification process for a total of 11,655 burden
hours (555 manufacturers/processors x 21 hours).
FDA expects that, each year, approximately 100 manufacturers/
processors will need to submit an occasional update and each
manufacturer/processor will require 0.5 hours to prepare a
communication to FDA reporting the change, for a total of 50 hours.
Dated: September 13, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-19890 Filed 9-18-17; 8:45 am]
BILLING CODE 4164-01-P
