Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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, 57282-57284 [2017-26042]
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<![CDATA[
57282
Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Notices
https://www.fda.gov/downloads/
MedicalDevices/DeviceRegulation
andGuidance/GuidanceDocuments/
ucm077295.pdf.
Modifications to the initial list of
recognized standards, as published in
the Federal Register, can be accessed at
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Standards/ucm123792.htm.
These notices describe the addition,
withdrawal, and revision of certain
standards recognized by FDA. The
Agency maintains hypertext markup
language (HTML) and portable
document format (PDF) versions of the
list of FDA Recognized Consensus
Standards. Additional information on
the Agency’s standards program is
available at https://www.fda.gov/
MedicalDevices/DeviceRegulation
andGuidance/Standards/default.htm.
II. Listing of New Entries, Recognition
List Number: 048
In table 1, FDA provides the listing of
new entries and consensus standards
added as modifications to the list of
recognized standards under Recognition
List Number: 048. FDA lists
modifications the Agency is making that
involve the initial addition of standards
not previously recognized by FDA.
TABLE 1—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS
Title of standard 1
Recognition No.
Reference No. and date
A. Radiology
12–307 .................
Radiation therapy readiness check .................................................................
AAMI RT2:2017.
B. Software/Informatics
13–98 ...................
13–99 ...................
13–100 .................
13–101 .................
13–102 .................
13–103 .................
1 All
Information technology—IS0 7-bit coded character set for information interchange.
Information technology—Automatic identification and data capture techniques—Unique identification—Part 2: Registration procedures.
Information technology—Automatic identification and data capture techniques—Unique identification—Part 4: Individual products and product
packages.
Information technology—Automatic identification and data capture techniques—Unique identification—Part 6: Groupings.
Application of risk management for IT-networks incorporating medical devices—Part 2–8: Application guidance—Guidance on standards for establishing the security capabilities identified in IEC TR 80001–2–2.
Application of risk management for IT-networks incorporating medical devices—Part 2–9: Application guidance—Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001–2–2 security
capabilities.
ISO/IEC 15459–2 Third edition 2015–03–01.
ISO/IEC 15459–4 Third edition 2014–11–15
Corrected version 2016–09–01.
ISO/IEC 15459–6 Second edition 2014–11–
15 Corrected version 2016–09–01.
IEC TR 80001–2–8 Edition 1.0 2016–05.
IEC TR 80001–2–9 Edition 1.0 2017–01.
standard titles in this table conform to the style requirements of the respective organizations.
III. List of Recognized Standards
FDA maintains the current list of FDA
Recognized Consensus Standards in a
searchable database that may be
accessed at https://
www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfStandards/search.cfm. FDA
will be incorporating the modifications
described in this notice into the
database and, upon publication in the
Federal Register, this recognition of
consensus standards will be effective.
FDA will be announcing additional
modifications and revisions to the list of
recognized consensus standards, as
needed, in the Federal Register once a
year, or more often if necessary.
sradovich on DSK3GMQ082PROD with NOTICES
ISO/IEC 646 Third edition 1991–12–15.
following information: (1) Title of the
standard, (2) any reference number and
date, (3) name and electronic or mailing
address of the requestor, (4) a proposed
list of devices for which a declaration of
conformity to this standard should
routinely apply, and (5) a brief
identification of the testing or
performance or other characteristics of
the device(s) that would be addressed
by a declaration of conformity.
Dated: November 29, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–26043 Filed 12–1–17; 8:45 am]
18:22 Dec 01, 2017
Jkt 244001
Food and Drug Administration
[Docket No. FDA–2014–N–0192]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
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
BILLING CODE 4164–01–P
AGENCY:
IV. Recommendation of Standards for
Recognition by FDA
Any person may recommend
consensus standards as candidates for
recognition under section 514 of the
FD&C Act by submitting such
recommendations, with reasons for the
recommendation, to
CDRHStandardsStaff@fda.hhs.gov. To
be considered, such recommendations
should contain, at a minimum, the
VerDate Sep<11>2014
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PO 00000
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:
Frm 00088
Fmt 4703
Sfmt 4703
E:\FR\FM\04DEN1.SGM
04DEN1
Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Notices
Fax written comments on the
collection of information by January 3,
2018.
ADDRESSES: 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 0910–0839. Also
include the FDA docket number found
in brackets in the heading of this
document.
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.
DATES:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
sradovich on DSK3GMQ082PROD with NOTICES
SUPPLEMENTARY INFORMATION:
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
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 and
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%20
Facilities%20_Beijing_China%20%20Peoples%20Republic%20of_6-272012.pdf), which became effective May
1, 2012. AQSIQ Decree 145, among
other requirements, mandates that
VerDate Sep<11>2014
18:22 Dec 01, 2017
Jkt 244001
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/CFSAN
(Center for Food Safety and Applied
Nutrition) 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. 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
PO 00000
Frm 00089
Fmt 4703
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57283
Children Manufacturers/Processors with
Interest in Exporting to China’’ which
can be found at https://www.fda.gov/
Food/GuidanceRegulation/default.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 who
may ship food products to China, which
we maintain. Updates to the FDA lists
are sent to CNCA, which publishes its
version of the information in the FDA
lists on China’s Web site (https://
english.cnca.gov.cn/) on a quarterly
basis. 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.
In the Federal Register of September
19, 2017 (82 FR 43761), we published a
60-day notice requesting public
comment on the proposed extension of
this collection of information. One
comment was received but was not
responsive to the four information
collection topics solicited in the notice
and therefore is not addressed.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\04DEN1.SGM
04DEN1
57284
Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Guidance recommendations
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
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
sradovich on DSK3GMQ082PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
This is a newly established
information collection. 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 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, to gather the information
needed, and to 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 to
remain on the lists. FDA estimates that
each year approximately half of the
manufacturers/processors on the lists, or
555 manufacturers/processors (1110
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
VerDate Sep<11>2014
18:22 Dec 01, 2017
Jkt 244001
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 (1110
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
FDA reporting the change, for a total of
50 hours.
Dated: November 29, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–26042 Filed 12–1–17; 8:45 am]
BILLING CODE 4164–01–P
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Center for
Advancing Translational Sciences Special
Emphasis Panel; CTSA.
Date: February 21, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda Marriott Suites,
Independence Ballrooms 1 & 2, 6711
Democracy Blvd., Bethesda, MD 20817.
Contact Person: Carol Lambert, Ph.D.,
Acting Director, Office of Scientific Review,
National Center for Advancing Translational
Sciences (NCATS), National Institutes of
Health, 6701 Democracy Blvd., Democracy 1,
Room 1076, Bethesda, MD 20892, 301–435–
0814, lambert@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.350, B—Cooperative
Agreements; 93.859, Biomedical Research
and Research Training, National Institutes of
Health, HHS)
Dated: November 28, 2017.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–25982 Filed 12–1–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Advancing
Translational Sciences; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
PO 00000
Frm 00090
Fmt 4703
Sfmt 4703
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
E:\FR\FM\04DEN1.SGM
04DEN1
]]>Agencies
[Federal Register Volume 82, Number 231 (Monday, December 4, 2017)]
[Notices]
[Pages 57282-57284]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26042]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0192]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) 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.
[[Page 57283]]
DATES: Fax written comments on the collection of information by January
3, 2018.
ADDRESSES: 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 0910-0839.
Also include the FDA docket number found in brackets in the heading of
this document.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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 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 and 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/CFSAN (Center for Food Safety and
Applied Nutrition) 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. 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''
which can be found at https://www.fda.gov/Food/GuidanceRegulation/default.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 who may ship food products to China, which we maintain.
Updates to the FDA lists are sent to CNCA, which publishes its version
of the information in the FDA lists on China's Web site (https://english.cnca.gov.cn/) on a quarterly basis. 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.
In the Federal Register of September 19, 2017 (82 FR 43761), we
published a 60-day notice requesting public comment on the proposed
extension of this collection of information. One comment was received
but was not responsive to the four information collection topics
solicited in the notice and therefore is not addressed.
FDA estimates the burden of this collection of information as
follows:
[[Page 57284]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Guidance recommendations Number of responses per Total annual burden per Total hours
respondents respondent responses 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.
This is a newly established information collection. 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 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, to gather the
information needed, and to 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 to remain on the lists. FDA
estimates that each year approximately half of the manufacturers/
processors on the lists, or 555 manufacturers/processors (1110
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 (1110
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: November 29, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26042 Filed 12-1-17; 8:45 am]
BILLING CODE 4164-01-P
