[Federal Register Volume 83, Number 63 (Monday, April 2, 2018)]
[Notices]
[Pages 13992-13994]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06595]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0369]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Regulations Under the Federal Import Milk Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 reporting and recordkeeping 
requirements of our regulations implementing the Federal Import Milk 
Act (FIMA).

DATES: Submit either electronic or written comments on the collection 
of information by June 1, 2018.

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 June 1, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of June 1, 2018. 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-2012-N-0369 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Regulations under the Federal 
Import Milk Act.'' 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 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

[[Page 13993]]

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, 10A-12M, 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.

Regulations Under the Federal Import Milk Act (FIMA)--21 CFR Part 1210

OMB Control Number 0910-0212--Extension

    Under FIMA (21 U.S.C. 141-149), milk or cream may be imported into 
the United States only by the holder of a valid import milk permit (21 
U.S.C. 141). Before such permit is issued: (1) All cows from which 
import milk or cream is produced must be physically examined and found 
healthy; (2) if the milk or cream is imported raw, all such cows must 
pass a tuberculin test; (3) the dairy farm and each plant in which the 
milk or cream is processed or handled must be inspected and found to 
meet certain sanitary requirements; (4) bacterial counts of the milk at 
the time of importation must not exceed specified limits; and (5) the 
temperature of the milk or cream at time of importation must not exceed 
50 [deg]F (21 U.S.C. 142).
    Our regulations in part 1210 (21 CFR part 1210), implement the 
provisions of FIMA. Sections 1210.11 and 1210.14 require reports on the 
sanitary conditions of, respectively, dairy farms and plants producing 
milk and/or cream to be shipped to the United States. Section 1210.12 
requires reports on the physical examination of herds, while Sec.  
1210.13 requires the reporting of tuberculin testing of the herds. In 
addition, the regulations in part 1210 require that dairy farmers and 
plants maintain pasteurization records (Sec.  1210.15) and that each 
container of milk or cream imported into the United States bear a tag 
with the product type, permit number, and shipper's name and address 
(Sec.  1210.22). Section 1210.20 requires that an application for a 
permit to ship or transport milk or cream into the United States be 
made by the actual shipper. Section 1210.23 allows permits to be 
granted based on certificates from accredited officials.
    We estimate the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Number of
       21 CFR section                Form FDA No.            Number of     responses per   Total annual     Average burden per response     Total hours
                                                            respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
1210.11....................  1996/Farm Inspection Report               2             200             400  1.5...........................             600
1210.12....................  1995/Report of Physical                   1               1               1  .5 (30 minutes)...............              .5
                              Examination of Cows.
1210.13....................  1994/Report of Tuberculin                 1               1               1  .5 (30 minutes)...............              .5
                              Tests of Cattle.
1210.14....................  1997/Score Card for                       2               1               2  2.............................               4
                              Sanitation Inspections of
                              Milk Plants.
1210.20....................  1993/Application for Permit               2               1               2  .5 (30 minutes)...............               1
                              to Ship or Transport Milk
                              and/or Cream into US.
1210.23....................  1815/Certificate/                         2               1               2  .5 (30 minutes)...............               1
                              Transmittal for an
                              Application.
                                                         -----------------------------------------------------------------------------------------------
    Total..................  ...........................  ..............  ..............  ..............  ..............................             607
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 13994]]


                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Number of
             21 CFR section                 Number of      records per    Total annual          Average burden per                  Total hours
                                          recordkeepers   recordkeeper       records              recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
1210.15................................               2               1               2  .05 (3 minutes)................  .10 (6 minutes)
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Upon review of the information collection, we have retained the 
currently approved estimated burden. The estimated number of 
respondents and hours per response are based on our experience with the 
import milk permit program and the average number of import milk permit 
holders over the past 3 years. Assuming two respondents will submit 
approximately 200 Form FDA 1996 reports annually for a total of 600 
responses, and that each response requires 1.5 hours, we estimate the 
total burden is 600 hours.
    The Secretary of Health and Human Services has the discretion to 
allow Form FDA 1815, a duly certified statement signed by an accredited 
official of a foreign government, to be submitted in lieu of Forms FDA 
1994 and 1995. To date, Form FDA 1815 has been submitted in lieu of 
these forms. Because we have not received any Forms FDA 1994 or 1995 in 
the last 3 years, we assume no more than one will be submitted 
annually. We also assume each submission requires 0.5 hour for a total 
of 0.5 burden hour annually.
    We estimate that two respondents will submit one Form FDA 1997 
report annually, for a total of two responses. We estimate the 
reporting burden to be 2.0 hours per response, for a total burden of 4 
hours. We estimate that two respondents will submit one Form FDA 1993 
report annually, for a total of two responses. We estimate the 
reporting burden to be 0.5 hour per response, for a total burden of 1 
hour. We estimate that two respondents will submit one Form FDA 1815 
report annually, for a total of two responses. We estimate the 
reporting burden to be 0.5 hour per response, for a total burden of 1 
hour.
    With regard to records maintenance, we estimate that approximately 
two recordkeepers will spend 0.05 hour annually maintaining the 
additional pasteurization records required by Sec.  1210.15, for a 
total of 0.10 hour annually.
    No burden has been estimated for the tagging requirement in Sec.  
1210.22 because the information on the tag is either supplied by us 
(permit number) or is disclosed to third parties as a usual and 
customary part of the shipper's normal business activities (type of 
product, shipper's name and address). Under 5 CFR 1320.3(c)(2), the 
public disclosure of information originally supplied by the Federal 
Government to the recipient for the purpose of disclosure to the public 
is not subject to review by the Office of Management and Budget under 
the Paperwork Reduction Act. Under 5 CFR 1320.3(b)(2)), the time, 
effort, and financial resources necessary to comply with a collection 
of information are excluded from the burden estimate if the reporting, 
recordkeeping, or disclosure activities needed to comply are usual and 
customary because they would occur in the normal course of business 
activities.

    Dated: March 27, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06595 Filed 3-30-18; 8:45 am]
 BILLING CODE 4164-01-P