[Federal Register: October 7, 2005 (Volume 70, Number 194)]
[Page 58709-58711]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2005N-0178]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Regulations Under the Federal Import 
Milk Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
November 7, 2005.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that comments be faxed to the 
Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, 
Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management 
Programs (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.
    Under the regulations implementing 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. 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

[[Page 58710]]

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. In addition, the regulations in part 1210 (21 CFR 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).
    In the Federal Register of May 31, 2005 (70 FR 30951), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions.
    FDA received one letter in response, which contained several 
comments and suggestions. These suggestions and FDA's responses follow.
    The comment stated that the collection of information in forms FDA 
1815, FDA 1993, FDA 1994, FDA 1995, FDA 1996, and FDA 1997 is necessary 
and that most of these forms provide practical information. However, 
the comment requested a number of changes to the forms. First, the 
comment suggested that certification of tuberculosis-free status in 
Form FDA 1815 and Form FDA 1994 should be done in a manner consistent 
with the U.S. Department of Agriculture's Animal Plant Health and 
Inspection Service (APHIS) guidelines entitled ``Bovine Tuberculosis 
Eradication Uniform Methods and Rules'' (APHIS 91-45-011). Another 
comment suggested that that Form FDA 1815 and Form FDA 1995 include a 
requirement that the submitter certify that the dairy cows are free 
from brucellosis and that the certification of brucellosis-free status 
should be done in a manner consistent with the APHIS guidelines 
published in the document entitled ``Brucellosis Eradication: Uniform 
Methods and Rules'' (APHIS 91-45-013).
    FDA agrees that, where possible, Federal agencies should act in a 
consistent manner. However, FDA declines to make the suggested changes 
to its forms because such changes are not necessary. The two referenced 
documents are published by APHIS as part of its national animal disease 
eradication efforts undertaken by the National Center for Animal Health 
Programs under the statutory authority provided by the Animal Health 
Protection Act (7 U.S.C. 8301-8320). These are domestic programs in the 
United States which are designed to address the general health status 
of U.S. domestic cattle. Under the statutory authority provided by 
FIMA, FDA regulates all foreign-produced milk and cream imported into 
the United States. FIMA requires certification of the general health of 
the animal, which certification is obtained by FDA on Form FDA 1995. 
Although the two statutory authorities may differ, the practices 
presented in the APHIS documents already are being followed by FDA. FDA 
considers the status of the brucellosis and tuberculosis control 
programs in the country offering milk for importation into the United 
States and bases its acceptance decision on that status.
    Another comment stated that Form FDA 1996 and Form FDA 1997 do not 
provide practical information and should be made consistent with Form 
FDA 2359a, which, the comment states, is ``utilized to ensure milk 
sanitation standards are met at the farm level.''
    FDA disagrees that Form FDA 1996, ``Dairy Farm Sanitation Report,'' 
and Form FDA 1997, ``Score Card for Sanitary Inspection of Milk 
Plants,'' do not provide practical information. The information 
collected on these two forms is used by the agency in determining 
whether the imported milk or cream offered for import meet FIMA's 
requirements for sanitary inspections of dairy farms and plants (21 
U.S.C. 142). FDA also disagrees that the two forms should be made 
consistent with Form FDA 2359a because that form is used domestically 
for inspection of facilities producing Grade ``A'' milk products. FDA 
does not use it for inspections of facilities producing manufacturing-
grade milk domestically. Thus, it would be inappropriate for FDA to use 
it for inspection of foreign facilities manufacturing non-Grade ``A'' 
milk products.
    The comment also opposed electronic submission of the forms and 
suggested that several changes should be made to the requirements of 
FIMA and the agency's related Compliance Policy Guide. These comments 
are outside the scope of the four collection of information topics on 
which the notice solicits comments and, thus, will not be addressed 
    FDA estimates the burden of this collection of information as 

                                                     Table 1.-- Estimated Annual Reporting Burden\1\
                                                                 No. of        Annual Frequency     Total Annual        Hours per
               Form No.                   21 CFR Section      Respondents        per Response        Responses           Response         Total Hours
FDA 1815/Permits granted on                       1210.23                  8                  1                  8                0.5                4.0
FDA 1993/Application of                           1210.20                  8                  1                  8                0.5                4.0
FDA 1994/Tuberculin test                          1210.13                  1                  1                  1                0.5                0.5
FDA 1995/Physical                                 1210.12                  1                  1                  1                0.5                0.5
examination of cows
FDA 1996/Sanitary inspection of dairy             1210.11                  8                200              1,600                1.5              2,400

[[Page 58711]]

FDA 1997/Sanitary                                 1210.14                  8                  1                  8                2.0               16.0
inspections of plants
Totals                                  .................  .................  .................  .................  .................            2,425.0
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
                                                           No. of        Annual Frequency  per      Total Annual        Hours per
                   21 CFR Section                      Recordkeepers             Record               Records          Recordkeeper       Total Hours
1210.15                                                              8                        1                  8                .05               0.40
\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 past 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, 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. Low burden has been estimated for 
Forms FDA 1994 and 1995 because they are not are not used often. 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.

    Dated: October 3, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-20148 Filed 10-6-05; 8:45 am]