[Federal Register Volume 79, Number 32 (Tuesday, February 18, 2014)]
[Notices]
[Pages 9221-9222]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-03389]



[[Page 9221]]

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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 
Milk Product Manufacturers/Processors With Interest in Exporting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the 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 
entitled, ``Establishing and Maintaining Lists of United States (U.S.) 
Milk Product Manufacturers/Processors with Interest in Exporting.''

DATES: Submit either electronic or written comments on the collection 
of information by April 21, 2014.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, [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. Milk Product Manufacturers/
Processors With Interest in Exporting (OMB Control Number 0910-0509)--
Revision

    The United States exports a large volume and variety of foods in 
international trade. For certain food products, foreign governments may 
require assurances from the responsible authority of the country of 
origin of an imported food that the processor of the food is in 
compliance with applicable country of origin regulatory requirements. 
With regard to U.S. milk products, FDA is the competent U.S. food 
safety authority to provide this information to foreign governments. We 
provide the requested information about processors in the form of 
lists. The lists are provided to the foreign governments and also 
posted online at http://www.fda.gov/Food/GuidanceRegulation/ImportsExports/Exporting/default.htm. The term ``milk product,'' for 
purposes of this information collection, includes products defined in 
21 CFR 1240.3(j) and any product requested by foreign governments to be 
included in this list process.
    We currently provide Chile a list of U.S. milk product 
manufacturers/processors that have expressed interest in exporting 
their products to Chile, are subject to our jurisdiction, and are not 
the subject of a pending judicial enforcement action (i.e., an 
injunction or seizure) or a pending warning letter. In the Federal 
Register of June 22, 2005 (70 FR 36190), we announced the availability 
of a revised guidance document entitled, ``Establishing and Maintaining 
a List of U.S. Dairy Product Manufacturers/Processors with Interest in 
Exporting to Chile.'' The guidance can be found at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ImportsExports/ucm078936.htm.
    FDA was asked to provide a list to China in response to China's 
State General Administration of the People's Republic of China for 
Quality Supervision and Inspection and Quarantine (AQSIQ) issuance of 
Administrative Measures for Registration of Overseas Manufacturers, 
known as AQSIQ Decree 145. Accordingly, we established and maintain for 
China a list that identifies U.S. milk product manufacturers/processors 
that have expressed interest to us in exporting milk products to China, 
are subject to our jurisdiction, and are not the subject of a pending 
judicial enforcement action (i.e., an injunction or seizure) or a 
pending warning letter. On January 9, 2014, we issued a guidance 
document entitled, ``Establishing and Maintaining a List of U.S. Milk 
Product Manufacturers/Processors with Interest in Exporting to China.'' 
The guidance can be found at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ImportsExports/ucm378777.htm.
    As noted, we provided the new list to China in response to AQSIQ 
Decree 145. In accordance with 5 CFR 1320.13, FDA requested emergency 
OMB review and approval of the collections of information found in the 
guidance document. The routine course of OMB approval would not have 
been in the best interest of the public health because it would have 
delayed our ability to collect the information from firms and, thus, 
would have been disruptive in our efforts to facilitate services that 
have been requested by China in AQSIQ Decree 145. OMB granted the 
approval under the emergency clearance procedures on November 7, 2013.
    The guidance documents are published under the authority of section 
701(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)), 
which authorizes the Secretary to develop guidance documents with 
public participation presenting the views of the Secretary on matters 
under the jurisdiction of the FDA.

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    The guidance documents explain what information firms should submit 
to us in order to be considered for inclusion on the lists and what 
criteria we intend to use to determine eligibility for placement on the 
lists. The guidance documents also explain how we intend to update the 
list and how we intend to communicate any new information to the 
government that requested the list. Finally, the guidance documents 
note that the information is provided voluntarily by firms with the 
understanding that it will be posted on our Web site and communicated 
to, and possibly further disseminated by, the government that requested 
the list; thus, we consider the information on the lists to be 
information that is not protected from disclosure under 5 U.S.C. 
552(b)(4).
    Application for inclusion on each list is voluntary. In the 
guidance documents, we recommend that U.S. firms that want to be placed 
on either list send the following information to us: Name and address 
of the firm and the manufacturing plant; name, telephone number, and 
email address (if available) of the contact person; a list of products 
presently shipped and expected to be shipped in the next 3 years; 
identities of agencies that inspect the plant and the date of last 
inspection; plant number and copy of last inspection notice; and, if 
other than an FDA inspection, copy of last inspection report. We 
request that this information be updated every 2 years.
    We use the information submitted by firms to determine their 
eligibility for placement on the list, which is published on our Web 
site. The purpose of the list is to help the governments of Chile and 
China in their determination of which U.S. milk product manufacturers 
are eligible to export to their respective countries.
    Description of Respondents: Respondents to this information 
collection include U.S. food product manufacturers/processors subject 
to our jurisdiction that wish to export products requested by foreign 
governments to be included in this list process.
    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                   125               1             125             1.5             188
 placed on the list.............
Biennial updates................             125               1             125             1.0             125
Occasional updates..............              50               1              50             0.5              25
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    Total.......................  ..............  ..............  ..............  ..............             338
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The estimate of the number of firms that will submit new written 
requests to be placed on the list, biennial updates, and occasional 
updates is based on the FDA's experience maintaining the list over the 
past 8 years. The estimate of the number of hours that it will take a 
firm to gather the information needed to be placed on the list or 
update its information is based on FDA's experience with firms 
submitting similar requests. FDA believes that the information to be 
submitted will be readily available to the firms.
    Based on submissions received for the Chile list over the past 3 
years and the China list over the past 3 months, we estimate that, 
annually, an average of 100 new firms will submit written requests to 
be placed on the China list and 25 new firms will seek to be placed on 
the Chile list, reported as 125 total respondents on line 1 of table 1. 
We estimate that a firm will require 1.5 hours to read the guidance, to 
gather the information needed, and to prepare a communication to FDA 
that contains the information and requests that the firm be placed on 
the list, for a total of 187.5 burden hours, rounded to 188, as 
reported on line 1 of table 1. Under the guidance, every 2 years each 
firm on the list must provide updated information in order to remain on 
the list.
    There are approximately 250 firms on the 2 lists combined. We 
estimate that, each year, approximately half of the firms on the list, 
125 firms, will resubmit the information to remain on the list. We 
estimate that a firm already on the list will require 1 hour to 
biennially update and resubmit the information to us, including time 
reviewing the information and corresponding with us, for a total of 125 
hours. In addition, we expect that, each year, approximately 50 firms 
will need to submit an occasional update and each firm will require 0.5 
hours to prepare a communication to us reporting the change, for a 
total of 125 hours.

    Dated: February 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03389 Filed 2-14-14; 8:45 am]
BILLING CODE 4160-01-P