[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]


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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.

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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, 
[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 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 
(http://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\
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                                                     Number of
            Activity                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per 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.

    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