View Information Collection Request (ICR) Package
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View Information Collection (IC) List
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0212
ICR Reference No:
202107-0910-004
Status:
Historical Active
Previous ICR Reference No:
201806-0910-003
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CFSAN
Title:
Regulations Under the Federal Import Milk Act
Type of Information Collection:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
08/09/2021
Retrieve Notice of Action (NOA)
Date Received in OIRA:
07/08/2021
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
08/31/2024
36 Months From Approved
08/31/2021
Responses
206
0
410
Time Burden (Hours)
307
0
609
Cost Burden (Dollars)
0
0
0
Abstract:
The Federal Import Milk Act (FIMA) prohibits the imporation of milk and cream into the United States unless the shipper holds a valid Import Milk permit from the Food and Drug Administration. The act requires that all cows be healthy and that the dairy farm and processing plant be in good sanitary condition. The purpose of the collection is to ensure compliance with FIMA. Respondents are foreign dairy farms and plants engaged in the importation of milk and/or cream into the United States.
Authorizing Statute(s):
US Code:
21 USC 141-149
Name of Law: Federal Import Milk Act
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
85 FR 70182
11/04/2020
30-day Notice:
Federal Register Citation:
Citation Date:
86 FR 31327
06/11/2021
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
7
IC Title
Form No.
Form Name
Regulations Under the Federal Import Milk Act
Regulations Under the Federal Import Milk Act
Form FDA 1996
Farm Inspection Report
Regulations Under the Federal Import Milk Act
Form FDA 1995
Physical Examination of Cows - Report
Regulations Under the Federal Import Milk Act
Form FDA 1815
Permits Granted on Certificates
Regulations Under the Federal Import Milk Act
Form FDA 1997
Score Card for Milk Plants
Regulations Under the Federal Import Milk Act
Form FDA 1993
Application for Permit
Regulations Under the Federal Import Milk Act
Form FDA 1994
Tuberculin Test
ICR Summary of Burden
Total Approved
Previously Approved
Change Due to New Statute
Change Due to Agency Discretion
Change Due to Adjustment in Estimate
Change Due to Potential Violation of the PRA
Annual Number of Responses
206
410
0
0
-204
0
Annual Time Burden (Hours)
307
609
0
0
-302
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
Based on a review of the information collection since our last OMB approval, we have decreased our burden estimate. 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. However, we have not received any responses in the last 3 years; therefore, we estimate that one or fewer to be submitted annually.
Annual Cost to Federal Government:
$20,986
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
No
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
No
Agency Contact:
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov
Common Form ICR:
No
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Certification Date:
07/08/2021
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