54562 Federal Register / Vol. 70, No. 178 / Thursday, September 15, 2005 / Notices 

SUPPLEMENTARY INFORMATION: 

I. Background 

The draft guidance is designed to 

assist sponsors and CDRH to oversee 

post-approval studies. These studies are 

oftentimes mandated at the time the 

Center approves a Premarket Approval 

Application (PMA) to address 

additional concerns. This guidance aims 

to assure that: 

• Sponsors submit clear, consistent 

and timely study reports; 

•CDRH can track the status of the 

studies; 

•CDRH staff reviews the studies and 

holds discussions with the sponsors in 

a timely manner; 

•CDRH stakeholders can quickly 

learn about the status of these studies; 

and 

•CDRH can take appropriate and 

timely action based on study results. 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on ‘‘Procedures for Handling PostApproval Studies Imposed by PMA 

Order.’’ It does not create or confer any 

rights for or on any person and does not 

operate to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statute 

and regulations. 

III. Electronic Access 

To receive ‘‘Procedures for PostApproval Studies Imposed by PMA 

Order’’ by fax machine, call the CDRH 

Facts-On-Demand system at 800–899–

0381 or 301–827–0111 from a touchtone telephone. Press 1 to enter the 

system. At the second voice prompt, 

press 1 to order a document. Enter the 

document number (1516) followed by 

the pound sign (#). Follow the 

remaining voice prompts to complete 

your request. 

Persons interested in obtaining a copy 

of the draft guidance may also do so by 

using the Internet. CDRH maintains an 

entry on the Internet for easy access to 

information including text, graphics, 

and files that may be downloaded to a 

personal computer with Internet access. 

Updated on a regular basis, the CDRH 

home page includes device safety alerts, 

Federal Register reprints, information 

on premarket submissions (including 

lists of approved applications and 

manufacturers’ addresses), small 

manufacturer’s assistance, information 

on video conferencing and electronic 

submissions, Mammography Matters, 

and other device-oriented information. 

The CDRH Web site may be accessed at 

http://www.fda.gov/cdrh. A search 

capability for all CDRH guidance 

documents is available at http:// 

www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available 

on the Division of Dockets Management 

Internet site at http://www.fda.gov/ 

ohrms/dockets. 

IV. Paperwork Reduction Act of 1995 

This draft guidance contains 

information collection provisions that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 USC 3501–3520). The collections of 

information addressed in the draft 

guidance document have been approved 

by OMB in accordance with the PRA 

under the regulations governing 

premarket approval applications (21 

CFR part 814, OMB control number 

0910–0231). 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES), written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments except that 

individuals may submit one copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: September 9, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–18372 Filed 9–14–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2004D–0251] 

Guidance for Industry, Food and Drug 

Administration Staff, and Food and 

Drug Administration-Accredited Third 

Parties; Requests for Inspection by an 

Accredited Person Under the 

Inspections by Accredited Persons 

Program Authorized by the Medical 

Device User Fee and Modernization 

Act of 2002; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Requests for Inspection by an 

Accredited Person under the Inspection 

by Accredited Persons Program 

Authorized by Section 201 of the 

Medical Device User Fee and 

Modernization Act of 2002.’’ The 

Medical Device User Fee and 

Modernization Act of 2002 authorizes 

FDA to establish a voluntary inspection 

program under which manufacturers of 

class II or class III devices who meet 

certain eligibility criteria as defined by 

the statute can elect to have FDAaccredited third parties conduct some of 

their establishment inspections instead 

of FDA. This guidance document 

describes the establishment eligibility 

criteria and the process for 

establishments to follow when 

requesting FDA’s approval to have an 

accredited person (AP) conduct an 

inspection of their establishment 

instead of FDA under the new 

Inspections by Accredited Persons 

Program (AP Program). 

DATES: Submit written or electronic 

comments on this guidance at any time. 

General comments on agency guidance 

documents are welcome at any time. 

ADDRESSES: Submit written requests for 

single copies on a 3.5′′ diskette of the 

guidance document entitled ‘‘Requests 

for Inspection by an Accredited Person 

under the Inspection by Accredited 

Persons Program Authorized by Section 

201 of the Medical Device User Fee and 

Modernization Act of 2002’’ to the 

Division of Small Manufacturers, 

International, and Consumer Assistance 

(HFZ–220), Center for Devices and 

Radiological Health, Food and Drug 

Administration, 1350 Piccard Dr., 

Rockville, MD 20850. Send one selfaddressed adhesive label to assist that 

office in processing your request, or fax 

your request to 301–443–8818. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. 

Submit written comments concerning 

this guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

For medical device issues: Casper E. 

Uldriks, Center for Devices and 

Radiological Health (HFZ–300), 

Food and Drug Administration, 

2098 Gaither Rd., Rockville, MD 

Federal Register / Vol. 70, No. 178 / Thursday, September 15, 2005 / Notices 54563 

20850, 240–276–0106. 

For biologics issues: Carol Rehkopf, 

Center for Biologics Evaluation and 

Research (HFM–650), Food and 

Drug Administration, 1401 

Rockville Pike, Rockville, MD 

20852, 301–827–6202. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On October 26, 2002, the Medical 

Device User Fee and Modernization Act 

of 2002 (MDUFMA) (Public Law 107–

250) was signed into law. Section 201 of 

MDUFMA amends the Federal Food, 

Drug, and Cosmetic Act (the act) by 

adding new provisions authorizing FDA 

to establish a voluntary inspection 

program under which eligible 

manufacturers of class II or class III 

devices can elect to have FDAaccredited third parties conduct some of 

their establishment inspections instead 

of FDA. Certain technical corrections 

were subsequently made to these 

provisions by the Medical Devices 

Technical Corrections Act (MDTCA) 

(Public Law 108–214), which was 

enacted on April 1, 2004. FDA 

announced in the Federal Register of 

June 3, 2004 (69 FR 31397), the 

availability of a draft guidance 

document entitled ‘‘Requests for 

Inspection by an Accredited Person 

under the Inspections by Accredited 

Persons Program Authorized by Section 

201 of the Medical Device User Fee and 

Modernization Act of 2002,’’ and 

invited interested persons to comment 

by September 1, 2004. 

One person submitted a comment in 

response to the draft guidance. The 

comment suggested, among other things, 

that partial inspections during a 2-year 

period should be permitted without the 

need for establishments to have to 

reapply to participate in the AP Program 

after each partial inspection. The 

comment further suggested that the 

guidance be revised to explicitly state 

that complete inspections conducted by 

APs under the new program which 

result in either a ‘‘No Action Indicated’’

or ‘‘Voluntary Action Indicated’’

classification can satisfy FDA’s biennial 

establishment inspection requirement 

under section 510(h) of the act (21 

U.S.C. 360(h)). The agency carefully 

considered the comment while 

finalizing the guidance and has revised 

the document accordingly. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on implementation of a 

new program that allows third-party 

inspections of eligible device 

establishments as authorized by section 

201 of MDUFMA (as amended by 

MDTCA). It does not create or confer 

any rights for or on any person and does 

not operate to bind FDA or the public. 

An alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statute 

and regulations. 

III. Electronic Access 

To receive ‘‘Requests for Inspection 

by an Accredited Person under the 

Inspection by Accredited Persons 

Program Authorized by Section 201 of 

the Medical Device User Fee and 

Modernization Act of 2002’’ by fax, call 

the CDRH Facts-On-Demand system at 

800–899–0381 or 301–827–0111 from a 

touch-tone telephone. Press 1 to enter 

the system. At the second voice prompt, 

press 1 to order a document. Enter the 

document number 1532 followed by the 

pound sign (#). Follow the remaining 

voice prompts to complete your request. 

Persons interested in obtaining a copy 

of the guidance may also do so by using 

the Internet. The Center for Devices and 

Radiological Health (CDRH) maintains 

an entry on the Internet for easy access 

to information including text, graphics, 

and files that may be downloaded to a 

personal computer with Internet access. 

Updated on a regular basis, the CDRH 

home page includes device safety alerts, 

Federal Register reprints, information 

on premarket submissions (including 

lists of approved applications and 

manufacturers’ addresses), small 

manufacturer’s assistance, information 

on video conferencing and electronic 

submissions, Mammography Matters, 

and other device-oriented information. 

The CDRH Web site may be accessed at 

http://www.fda.gov/cdrh. A search 

capability for all CDRH guidance 

documents is available at http:// 

www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available 

on the Division of Dockets Management 

Internet site at http://www.fda.gov/ 

ohrms/dockets. 

IV. Paperwork Reduction Act of 1995 

This guidance contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (the PRA) (44 

U.S.C. 3501–3520). The collections of 

information addressed in the guidance 

document have been approved by OMB 

in accordance with the PRA under the 

regulations governing the agency 

request or requirement that members of 

the public submit reports, keep records, 

or provide information to a third party. 

The provisions addressed in the 

guidance have been approved by OMB 

under OMB control number 0910–0569. 

This approval expires on August 31, 

2008. An agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a currently valid OMB 

control number. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: September 9, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–18364 Filed 9–14–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Bureau of U.S. Customs and Border 

Protection 

Notice of Issuance of Final 

Determination Concerning Desktop 

Scanners 

AGENCY: U.S. Customs and Border 

Protection, Department of Homeland 

Security. 

ACTION: Notice of final determination. 

SUMMARY: This document provides 

notice that the Bureau of Customs and 

Border Protection (CBP) has issued a 

final determination concerning the 

country of origin of certain desktop 

scanners to be offered to the United 

States Government under an 

undesignated government procurement 

contract. The final determination found 

that, based upon the facts presented, the 

United States is the country of origin of 

the Kodak i600 line of desktop scanners 

for purposes of U.S. Government 

procurement. The Kodak i600 series 

includes the i620, i640, and i660 

models. 

DATES: The final determination was 

issued on September 9, 2005. A copy of 

the final determination is attached. Any 

party-at-interest, as defined in 19 CFR 

177.22(d), may seek judicial review of 

this final determination within 30 days 

of September 15, 2005.