Federal Register / Vol. 73, No. 165 / Monday, August 25, 2008 / Notices 50031 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

60 1 1 1.0 60.0 

1There are no capital costs or operating and maintenance costs for this information collection. 

The study will involve about 60 

respondents and take approximately 1 

hour each to complete. These estimates 

are based on the contractor’s extensive 

experience with mental models 

research. FDA conducted pretests of the 

mental models protocol with six health 

care providers. These resulted in the 

current protocol. 

Dated: August 18, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–19653 Filed 8–22–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0453] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Regulations Under 

the Federal Import Milk Act 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

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 

the reporting and recordkeeping 

requirements of FDA’s regulations 

implementing the Federal Import Milk 

Act (FIMA). 

DATES: Submit written or electronic 

comments on the collection of 

information by October 24, 2008. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (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: 

Jonna Capezzuto, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794. 

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, 

including each proposed extension of an 

existing 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 these topics: (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 Number 0910–0212)—Extension 

Under 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). 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° F (21 

U.S.C. 142). 

FDA’s regulations in part 1210 (21 

CFR part 1210) implement the 

provisions of FIMA. Sections 1210.11 

and 1210.14 require reports on the 

sanitary conditions of, respectively, 

dairy farms and plants producing milk 

and/or cream to be shipped to the 

United States. Section 1210.12 requires 

reports on the physical examination of 

herds, while § 1210.13 requires the 

reporting of tuberculin testing of the 

herds. In addition, the regulations in 

part 1210 require that dairy farmers and 

plants maintain pasteurization records 

(§ 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 (§ 1210.22). Section 1210.20 

requires that an application for a permit 

to ship or transport milk or cream into 

the United States be made by the actual 

shipper. Section 1210.23 allows permits 

to be granted based on certificates from 

accredited officials. 


ebenthall on PRODPC60 with NOTICES
50032 Federal Register / Vol. 73, No. 165 / Monday, August 25, 2008 / Notices 

TABLE 1.— ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section Form No. No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

1210.11 FDA 1996/Sanitary 

inspection of dairy 

farms 

8 200 1,600 1.5 2,400 

1210.12 FDA 1995/Physical 

examination of 

cows 

1 1 1 0.5 0.5 

1210.13 FDA 1994/Tuberculin 

test 

1 1 1 0.5 0.5 

1210.14 FDA 1997/Sanitary 

inspections of 

plants 

8 1 8 2.0 16.0 

1210.20 FDA 1993/Application for permit 8 1 8 0.5 4.0 

1210.23 FDA 1815/Permits 

granted on certificates 

8 1 8 0.5 4.0 

Totals 2,425.0 

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

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of Recordkeepers Annual Frequency per 

Recordkeeping Total Annual Records Hours per Record Total Hours 

1210.15 8 1 8 0.05 0.40 

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

The estimated number of respondents 

and hours per response are based on 

FDA’s experience with the import milk 

permit program and the average number 

of import milk permit holders over the 

past 3 years. FDA estimates that eight 

respondents will submit approximately 

200 Form FDA 1996 reports annually, 

for a total of 1,600 responses. FDA 

estimates the reporting burden to be 1.5 

hours per response, for a total burden of 

2,400 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 FDA has not received any 

Forms FDA 1994 and 1995 in the last 3 

years, the agency estimates no more 

than one will be submitted annually. 

FDA estimates the reporting burden for 

each to be 0.5 hours per response for a 

total burden reporting burden of 0.5 

hours each. 

FDA estimates that eight respondents 

will submit one Form FDA 1997 report 

annually, for a total of eight responses. 

FDA estimates the reporting burden to 

be 2.0 hours per response, for a total 

burden of 16 hours. FDA estimates that 

eight respondents will submit one Form 

FDA 1993 report annually, for a total of 

eight responses. FDA estimates the 

reporting burden to be 0.5 hours per 

response, for a total burden of 4 hours. 

FDA estimates that eight respondents 

will submit one Form FDA 1815 report 

annually, for a total of eight responses. 

FDA estimates the reporting burden to 

be 0.5 hours per response, for a total 

burden of 4 hours. 

With regard to records maintenance, 

FDA estimates that approximately eight 

recordkeepers will spend 0.05 hours 

annually maintaining the additional 

pasteurization records required by 

§ 1210.15, for a total of 0.40 hours 

annually. 

No burden has been estimated for the 

tagging requirement in § 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. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

Dated: August 18, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–19627 Filed 8–22–08; 8:45 am] 

BILLING CODE 4160–01–S 


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