Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Notices 55487 

TABLE 5.—ESTIMATED ANNUAL REPORTING BURDEN FOR ANIMAL DRUGS1

21 CFR Section No. of Respondents Annual Frequency per 

Response 

Total Annual Responses Hours per Respondent Total Hours 

25.15(a) and (d) 134 3.9 421 8 3,368 

25.40(a) and (c) 12 1.6 14 2,160 30,240 

Total 33,608 

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

Based on information provided by 

industry, FDA estimates that the 

combined annual total burden hours for 

all centers is 170,352. 

Dated: September 15, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 06–8025 Filed 9–21–06; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006N–0380] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Export of Medical 

Devices-Foreign Letters of Approval 

AGENCY: Food and Drug Administration 

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 information 

collection, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

reporting requirements for firms that 

intend to export certain unapproved 

medical devices. 

DATES: Submit written or electronic 

comments on the collection of 

information by November 21, 2006. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://www.fda.gov/ 

dockets/ecomments. 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: 

Denver Presley, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857,301–827–1472. 

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. 

Export of Medical Devices-Foreign 

Letters of Approval (OMB Control 

Number 0910–0264)—Extension 

Section 801(e)(2) of the Federal Food, 

Drug, and Cosmetic Act (the act) (21 

U.S.C. 381(e)(2)) provides for the 

exportation of an unapproved device 

under certain circumstances if the 

exportation is not contrary to the public 

health and safety and it has the approval 

of the foreign country to which it is 

intended for export. 

Requesters communicate (either 

directly or through a business associate 

in the foreign country) with a 

representative of the foreign government 

to which they seek exportation, and 

written authorization must be obtained 

from the appropriate office within the 

foreign government approving the 

importation of the medical device. An 

alternative to obtaining written 

authorization from the foreign 

government is to accept a notarized 

certification from a responsible 

company official in the United States 

that the product is not in conflict with 

the foreign country’s laws. This 

certification must include a statement 

acknowledging that the responsible 

company official making the 

certification is subject to the provisions 

of 18 U.S.C. 1001. This statutory 

provision makes it a criminal offense to 

knowingly and willingly make a false or 

fraudulent statement, or make or use a 

false document, in any manner within 

the jurisdiction of a department or 

agency of the United States. 

FDA uses the written authorization 

from the foreign country or the 

certification from a responsible 

company official in the United States to 

determine whether the foreign country 

has any objection to the importation of 

the device into their country. 

The respondents to this collection of 

information are companies that seek to 

export medical devices. 

FDA estimates the reporting burden of 

this collection of information as follows: 


sroberts on PROD1PC70 with NOTICES
55488 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

801(e)(2) 25 1 25 2.5 62.5 

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

The burden estimates are based on the 

experience of FDA’s medical device 

program personnel. 

Dated: September 15, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 06–8026 Filed 9–21–06; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006N–0381] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Mammography 

Quality Standards Act Requirements 

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 estimated reporting and 

recordkeeping burden associated with 

the Mammography Quality Standards 

Act requirements. 

DATES: Submit written or electronic 

comments on the collection of 

information by November 21, 2006. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to: http://www.fda.gov/ 

dockets/ecomments. 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: 

Denver Presley, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1472. 

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. 

The Mammography Quality Standards 

Act Requirements—21 CFR Part 900 

(OMB Control Number 0910–0309)—

Extension 

The Mammography Quality Standards 

Act requires the establishment of a 

Federal certification and inspection 

program for mammography facilities; 

regulations and standards for 

accreditation and certification bodies for 

mammography facilities, and standards 

for mammography equipment, 

personnel, and practices, including 

quality assurance. The intent of these 

regulations is to assure safe, reliable, 

and accurate mammography on a 

nationwide level. 

Under the regulations, as a first step 

in becoming certified, mammography 

facilities must become accredited by an 

FDA approved accreditation body. This 

requires undergoing a review of their 

clinical images and providing the 

accreditation body with information 

showing that they meet the equipment, 

personnel, quality assurance and quality 

control standards, and have a medical 

reporting and recordkeeping program, a 

medical outcomes audit program, and a 

consumer compliant mechanism. On the 

basis of this accreditation, facilities are 

then certified by FDA or an FDAapproved State certification agency and 

must prominently display their 

certificate. These actions are taken to 

ensure safe, accurate, and reliable 

mammography on a nationwide basis. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section/ 

FDA Form 

No. of 

Respondents 

Annual 

Frequency 

perResponse 

Total Annual 

Records 

Hours per 

Response Total Hours Total Capital Costs 

Total Operating & 

Maintenance Costs 

900.3(b)(1) 0.33 1 0.33 1 0.33 

900.3(b)(3) full1 0.33 1 0.33 320 106 $10,000 


sroberts on PROD1PC70 with NOTICES