
[Federal Register Volume 79, Number 100 (Friday, May 23, 2014)]
[Notices]
[Pages 29777-29779]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-11927]


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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 a List of United States Dairy 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) 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.

DATES: Fax written comments on the collection of information by June 
23, 2014.

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 0910-0509. 
Also include the FDA 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, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, 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.

[[Page 29778]]

Establishing and Maintaining Lists of U.S. Milk Product Manufacturers/
Processors With Interest in Exporting (OMB Control Number 0910-0509)--
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 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/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 FDA.
    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.
    In the Federal Register of February 18, 2014 (79 FR 9221) FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Two comments were received; however, they 
were not responsive to the information collection topics solicited in 
the notice.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
            Activity                 Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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New written requests to be                   125               1             125             1.5             188
 placed on the list.............
Biennial update.................             125               1             125               1             125
Occasional updates..............              50               1              50          \2\0.5              25
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[[Page 29779]]

 
    Total.......................  ..............  ..............  ..............  ..............             338
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ 30 minutes.

    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 
hour to prepare a communication to us reporting the change, for a total 
of 125 hours.

    Dated: May 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-11927 Filed 5-22-14; 8:45 am]
BILLING CODE 4160-01-P


