0212 FIMA SSA 2018 Ext

United States Food and Drug Administration
Regulations Under The Federal Import Milk Act
OMB Control No. 0910-0212
SUPPORTING STATEMENT Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports agency regulations. Under the Federal Import Milk Act
(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), as issued by the Food and Drug
Administration. Before such permit is issued by FDA: (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° F (21 U.S.C. 142). Regulations at 21 CFR Part 1210 have
been promulgated establishing these provisions.
To assist respondents with the regulatory requirements we have developed the following
forms:
Form FDA 1815 Form FDA 1993 Form FDA 1994 Form FDA 1995 Form FDA 1996 Form FDA 1997 -

Certificate/Transmittal for an Application (21 CFR 1210.23)
Application for Permit to Ship or Transport Milk and /or Cream into
the United States (21 CFR 1210.20)
Report of Tuberculin Tests of Cattle (21 CFR 1210.13)
Report of Physical Examination of Cows (21 CFR 1210.12)
Dairy Farm Sanitary Report (21 CFR 1210.11)
Score Card for Sanitary Inspection of Milk Plants (21 CFR 1210.14)

We therefore request extension of OMB approval for the information collection provisions
found in 21 CFR Subchapter L; Part 1210 – Regulations Under Certain Other Acts
Administered by the Food and Drug Administration – Regulations Under the Federal Import
Milk Act and the associated forms, as discussed in this supporting statement.
2. Purpose and Use of the Information Collection
The information is used by the Food and Drug Administration (FDA) to determine whether
a permit to import milk and/or cream into the United States should be granted.
Description of Respondents: The respondents include foreign dairy farms and plants
engaged in transporting milk and/or cream into the United States. Respondents are from the
private sector (for- profit businesses).

3. Use of Improved Information Technology and Burden Reduction
The major portion of the annual burden for this information collection is associated with
Form FDA 1996: Dairy Farm Sanitary Report. This form is completed by a sanitarian onsite in rural areas. Under these circumstances, electronic data entry would most likely
increase the burden rather than reduce the burden. However, industry is increasingly turning
to the use of automatic production facilities. Any use of improved technology appropriate to
satisfy our regulations is acceptable. We estimate that about fifty percent (50%) of the
reports will be submitted electronically in the next three years.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection. The information collected in
fulfilling the statutory requirements for applying for a permit to import under FIMA is
unique to the dairy herds which are the source of the milk and the plants in which the
product is pasteurized. Because FDA is the only Federal agency with the authority to issue
permits to import milk under FIMA, duplication by other Federal agencies is unlikely.
5. Impact on Small Businesses or Other Small Entities
We estimate that fifty percent (50%) of respondents are small businesses; however we
estimate no undue burden on small entities. Small firms may also apply for a permit. The
forms to be completed are simplified to the extent possible, consisting of check boxes and
short narrative responses. We will assist small firms with these requirements thus
minimizing the burden. We aid small businesses in complying with our requirements
through our Regional Small Business Representatives and through our scientific and
administrative staffs. We also provide a Small Business Guide on our website at
http://www.fda.gov/oc/industry/.
6. Consequences of Collecting the Information Less Frequently
Data collection occurs occasionally. Under FIMA and our implementing regulations,
submission of the required information and approval of the information after our review is a
condition precedent to the issuance of a permit. Therefore, if the information is not
submitted, we cannot issue a permit to the importing party, and the milk and/or cream
offered for import would be denied entry into the United States.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances associated with this collection of information.

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8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), FDA published a 60 day notice for public comment in
the Federal Register of April 2, 2018 (83 FR 13992). No comments were received. Please
note, however, nominal calculation nuances as discussed in Question 12, below.
9. Explanation of Any Payment or Gift to Respondents
We do not provide any payments or gifts to respondents.
10. Assurance of Confidentiality Provided to Respondents
The information and data collected do not concern any method or processing which is
entitled to protection as a trade secret nor is it concerned with matters that are commonly
considered private or sensitive in nature. No assurance of confidentiality is given.
11. Justification for Sensitive Questions
This information collection does not involve any questions that are of a personally sensitive
nature.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
We estimate the burden of this collection of information as follows:
Table 1.--Estimated Annual Reporting Burden1
21 CFR
Section

Form FDA No.

1210.11

1996/Sanitary inspection of
dairy farms
1995/Physical examination
of cows
1994/Tuberculin test
1997/Sanitary inspections of
plants
1993/Application for permit
1815/Permits granted on
certificates

1210.12
1210.13
1210.14
1210.20
1210.23
1

Number of
Respondents

Number of
Responses per
Respondent

Total
Annual
Responses

Average
Burden
per
Response

Total
Hours

2

200

400

1.5

600

1

1

1

0.5

0.5

1
2

1
1

1
2

0.5
2.0

0.5
4.0

2
2

1
1

2
2

0.5
0.5

1.0
1.0

Total
607.0
There are no capital costs or operating and maintenance costs associated with this collection of information.

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Table 2.--Estimated Annual Recordkeeping Burden1
21 CFR Section

Number of
Recordkeepers

Number of Records
per Recordkeeper

Total
Annual
Records

Average Burden per
Recordkeeping

Total
Hours

1210.15
2
1
2
0.05
0.10
1
There are no capital costs or operating and maintenance costs associated with this collection of information.

In our Federal Register of April 2, 2018 (83 FR 13992), the reporting burden reflects 607.0
hours, as burden associated with sections 1210.12 and 1210.13 were not rounded up to 1
hour. FDA notes that these figures are rounded up as they appear at reginfo.gov and thus the
reporting burden reflects 609 hours. Similarly, the recordkeeping burden in our notice is not
rounded, thus at reginfo.gov the burden is reflected as one hour.
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 three years. We estimate that two respondents will submit approximately 200
Form FDA 1996 reports annually, for a total of 400 responses. FDA estimates the reporting
burden to be 1.5 hours per response, for a total burden of 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 and
1995 in the last three years, the agency estimates no more than one will be submitted
annually. We estimate the reporting burden for each to be 0.5 hours per response for a total
burden reporting burden (rounded) of 1 hour each.
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. We estimate the reporting burden to be 0.5 hours per response, for a total
burden of 1 hour. We estimate that two respondents each will submit one Form FDA 1815
report annually. We estimate the reporting burden to be 0.5 hours per response, for a total
burden of 1 hour.
With regard to records maintenance, we estimate that two recordkeepers will spend 0.05
hours annually maintaining the additional pasteurization records required by § 1210.15, for a
total of 0.10 hours annually, rounded up to 1 hour.
No burden has been estimated for the tagging requirement in § 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

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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.
12b. Annualized Cost Burden Estimate
We estimate the annualized burden hour cost to a respondent for completion and submission
of the required forms to be approximately $60,364. FDA estimates a respondent’s average
wage to be that of a Federal government employee at the GS-13/Step-3 rate for the
Washington-Baltimore locality pay area for the year 2018, which makes the annual wage
cost for completion and submission approximately $30,182 (609 hours x $49.56 per hour).
To account for overhead, this cost is increased by 100 percent, making the total estimated
burden hour cost to the respondent $60,364.
Activity
Completion and
submission of
required forms

Total Burden
Hours
609

Hourly Wage Rate
$99.12 ($49.56 x 2)

Total Respondent
Costs
$60,364

13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no capital, start-up, operating, or maintenance costs associated with this
collection. Many of the requirements of FDA’s regulations are also regulatory requirements
of the country in which the firm is located. By complying with their own country’s
regulations respondents also comply with many of ours, mitigating cost burden. This
applies particularly to tuberculosis testing and physical examination of herds, which are
required by the government of New Zealand.
14. Annualized Cost to the Federal Government
We estimate that the staffing allocation to review and respond to the current level of
applications for a permit to import milk and/or cream to this country is 160 hours at rate of
$49.56 per hour, the GS- 13/Step-3 rate for the Washington-Baltimore locality pay area for
the year 2018 (160 hours x $49.56 per hour = $7,929.60). Additional reviews at the
Division, office/center and Associate Commissioner levels are estimated by program
specialists to take an additional 16 hours at an aggregate rate of $49.56 per hour, the GS13/Step-3 rate for the Washington-Baltimore locality pay area for the year 2018 (16 hours x
$49.56 per hour = $792.96). Thus, the total cost is $8,722.56 ($7,929.60 + $792.96). To
account for overhead, this cost is increased by 100 percent, making the total estimated
annual cost to the Federal Government $17,445.12, rounded to $17,445.

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15. Explanation for Program Changes or Adjustments
We retain the currently approved burden for the information collection.
16. Plans for Tabulation and Publication and Project Time Schedule
The information obtained from this data collection will not be published.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
No approval is requested for FDA to not display the expiration date of OMB approval.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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