[Federal Register Volume 67, Number 71 (Friday, April 12, 2002)]
[Notices]
[Pages 18013-18014]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-8840]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0112]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) 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 reporting and recordkeeping 
requirements in implementing the Federal Import Milk Act (FIMA).

DATES: Submit written or electronic comments on the collection of 
information by June 11, 2002.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (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: Peggy Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

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, 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: (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 (21 CFR Part 1210) 
(OMB Control No. 0910-0212)--Extension

    FIMA (21 U.S.C. 141-149) provides that milk or cream may be 
imported into the United States only by the holder of a valid import 
milk permit. 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. The regulations in 21 CFR 1210.15 require that dairy farmers 
and plants maintain pasteurization records. The regulations in 21 CFR 
1210.22 require 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.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 18014]]



                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                                   Annual Frequency    Total Annual
               FDA Form No.                21 CFR Section    No. of Respondents      per Response        Responses    Hours per Response    Total Hours
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FDA 1815/Permits granted on certificates      1210.23                         8           1                 8                 0.5               4
FDA 1993/Application of permit                1210.20                         8           1                 8                 0.5               4
FDA 1994/Tuberculin test                      1210.13                         1           1                 1                 1                 1
FDA 1995/Physical examination of cows         1210.12                         1           1                 1                 1                 1
FDA 1996/Sanitary inspection of dairy         1210.11                         8         200             1,600                 1.5           2,400
 farms
FDA 1997/Sanitary inspections of plants       1210.14                         8           1                 8                 2.0              16
Total                                                                                                                                       2,426
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
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                                                                                                                                                    Total
                                                           Annual Frequency    Total Annual                                              Total   Operating &
       21 CFR Section            No. of Recordkeepers      per Recordkeeping      Records      Hours per Recordkeeper     Total Hours   Capital  Maintenance
                                                                                                                                         Costs      Costs
-------------------------------------------------------------------------------------------------------------------------------------- ----------------------
1210.15                                   8                       1                 8                             .05          .4
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    These estimates are based on the number of current permit holders 
and the number of inquiries that FDA has received regarding requests 
for applications in the next 3 years.
    No burden has been estimated for the tagging requirement in 
Sec. 1210.22 because the information on the tag is either supplied by 
FDA (permit number) or is disclosed to third parties as a usual and 
customary part of the shipper's normal business activities (type of 
product and 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 a collection of information. 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 activities. 
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.

    Dated: April 5, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-8840 Filed 4-11-02; 8:45 am]
BILLING CODE 4160-01-S