[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]


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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.

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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 [email protected]. 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, 
[email protected].

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 (http://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\
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                                                     Number of                        Average
    Guidance recommendations         Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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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
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    Total.......................  ..............  ..............  ..............  ..............          20,400
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\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