[Federal Register Volume 67, Number 138 (Thursday, July 18, 2002)]
[Notices]
[Pages 47388-47389]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-18123]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 02N-0102 and 02N-0112]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Regulations Under the Federal Import Milk Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995. This document also corrects 
some inadvertent typographical errors that published in the Federal 
Register of June 28, 2002 (67 FR 43633).

DATES: Submit written comments on the collection of information by 
August 19, 2002.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Stuart Shapiro, Desk Officer for FDA.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Regulations Under the Federal Import Milk Act (FIMA) Part 1210 (21 CFR 
Part 1210) (OMB Control Number 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 Sec. 1210.15 require that dairy farmers 
and plants maintain pasteurization records. The regulations in 
Sec. 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:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
 FDA Form                                        Annual Frequency    Total Annual     Hours per
    No.     21 CFR Section  No. of Respondents     per Response        Responses      Response      Total Hours
----------------------------------------------------------------------------------------------------------------
FDA 1815/      1210.23              8                   1                 8              0.5            4
 Permits
 granted
 on
 certifica
 tes
FDA 1993/      1210.20              8                   1                 8              0.5            4
 Applicati
 on for
 permit
FDA 1994/      1210.13              1                   1                 1              1              1
 Tuberculi
 n test
FDA 1995/      1210.12              1                   1                 1              1              1
 Physical
 examinati
 on of
 cows
FDA 1996/      1210.11              8                 200             1,600              1.5        2,400
 Sanitary
 inspectio
 n of
 daily
 farms
FDA 1997/      1210.14              8                   1                 8              2             16
 Sanitary
 inspectio
 n of
 plants
Totals                                                                                              2,426
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 47389]]


                               Table 2.--Estimated Annual Recordkeeping Burden\1\
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                      No. of       Annual Frequency per                              Hours per
 21 CFR Section    Recordkeepers       Recordkeepers       Total Annual Records    Recordkeeper     Total Hours
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1210.15                 8                   1                       8                   0.5              .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.
    In FR Doc. 02-16343, appearing on page 43633 in the Federal 
Register of Friday, June 28, 2002, for Docket No. 02N-0102 the 
following corrections are made.
    1. On page 43633, in the third column, the title ``Agency 
Information Collection Activities; Submission for OMB Review; Comment 
Request; Medical Devices; Notification of a Health Claim or Nutrient 
Content Claim Based on an Authoritative Statement of a Scientific 
Body'' is corrected to read ``Agency Information Collection Activities; 
Comment Request; Notification of a Health Claim Based on an 
Authoritative Statement of a Scientific Body''.
    2. On page 43634, in the first and second columns, the title 
``Guidance for Industry: Notification of a Health Claim or Nutrient 
Content Claim Based on an Authoritative Statement of a Scientific 
Body'' is corrected to read ``Guidance for Industry: Notification of a 
Health Claim Based on an Authoritative Statement of a Scientific 
Body.''.

    Dated: July 10, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-18123 Filed 7-17-02; 8:45 am]
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