1692 Federal Register / Vol. 74, No. 8 / Tuesday, January 13, 2009 / Notices 

Committee Name Tentative Date of Meeting(s) 

Advisory Committee 

10-Digit Information 

Line Code 

Anesthesiology and Respiratory Therapy Devices Panel February 5, April 30, July 23, September 17, November 12 3014512624 

Circulatory System Devices Panel February 25, May 27, September 24 3014512625 

Clinical Chemistry and Clinical Toxicology Devices Panel March 18–19, June 17–18, October 21–22 3014512514 

Dental Products Panel February 11, May 6, June 17, September 16, December 9 3014512518 

Ear, Nose, and Throat Devices Panel February 24, May 19, August 18, November 17 3014512522 

Gastroenterology-Urology Devices Panel March 20, October 15 3014512523 

General and Plastic Surgery Devices Panel February 26–27, June 9–10, October 15–16 3014512519 

General Hospital and Personal Use Devices Panel March 25–26, July 29–30, October 21–22 3014512520 

Hematology and Pathology Devices Panel April 24, July 17, October 23 3014512515 

Immunology Devices Panel October 15–16 3014512516 

Medical Devices Dispute Resolution Panel Meetings occur as needed 3014510232 

Microbiology Devices Panel February 24–25, September 22–23, October 27–28 3014512517 

Molecular and Clinical Genetics Panel April 15, October 5–6 3014510231 

Neurological Devices Panel February 26–27, May 14–15, September 17–18, December 2–3 3014512513 

Obstetrics and Gynecology Devices Panel February 5–6, May 14–15, August 13–14, November 12– 

13 

3014512524 

Ophthalmic Devices Panel February 12–13, May 14–15, September 24–25,November 

19–20 

3014512396 

Orthopaedic and Rehabilitation Devices Panel February 3–4, April 14–15, June 9–10, August 11–12, October 15–16, December 1–2 3014512521 

Radiological Devices Panel February 18, May 12, August 4, November 17 3014512526 

National Mammography Quality Assurance Advisory Committee November 4–5 3014512397 

Technical Electronic Product Radiation Safety Standards 

Committee 

No meeting tentatively scheduled for 2009 3014512399 

CENTER FOR FOOD SAFETY AND APPLIED NUTRITION 

Food Advisory Committee May 20–21 3014510564 

CENTER FOR VETERINARY MEDICINE 

Veterinary Medicine Advisory Committee April 14 3014512548 

NATIONAL CENTER FOR TOXILOGICAL RESEARCH (NCTR) 

Science Advisory Board to NCTR November 17–18 3014512559 

Dated: December 24, 2008. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E9–451 Filed 1–12–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0675] 

Draft Guidance for Industry on Good 

Importer Practices; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing on 

behalf of several members of the 

Interagency Working Group on Import 

Safety (agencies) the availability of a 

draft guidance for industry entitled 

‘‘Good Importer Practices.’’ This draft 

guidance document provides general 

recommendations to importers on 

possible practices and procedures they 

may follow to increase the likelihood 

the products they import are in 

Federal Register / Vol. 74, No. 8 / Tuesday, January 13, 2009 / Notices 1693 

1 The agencies who developed this draft guidance 

are the U.S. Consumer Product Safety Commission, 

the Department of Agriculture, the Department of 

Commerce, the Department of Health and Human 

Services (FDA), the Department of Homeland 

Security, the Department of Transportation, and the 

Environmental Protection Agency, as well as with 

input from the Office of the U.S. Trade 

Representative. 

2 While this guidance document sets out 

principles and recommendations for helping to 

ensure the safety and security of imported products, 

the principles and the non-customs related 

recommendations are also applicable to helping 

ensure the safety and security of products that are 

domestically produced. 

compliance with applicable U.S. safety 

and security requirements. The 

recommendations provided here are 

intended to promote and facilitate an 

assessment by importers of a product’s 

life cycle so the importer may make 

sound decisions about how best to 

address the product’s potential to cause 

harm and to facilitate compliance with 

U.S. requirements. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agencies 

consider your comments on this draft 

guidance before they begin work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance by April 13, 2009. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Food and Drug Administration, Office of 

Policy and Planning, 10903 New 

Hampshire Ave., White Oak Building 1, 

4th Floor,Silver Spring, MD 20993. 

Send one self-addressed adhesive label 

to assist the office in processing your 

request.Submit written comments on 

the draft 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.regulations.gov. All comments 

should be identified with the docket 

number found in brackets in the 

heading of this document. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Jeffrey Shuren, Food and Drug 

Administration, 10903 New Hampshire 

Avenue, White Oak Building 1, Silver 

Spring, MD 20993, 301–796–4840. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing on behalf of the 

agencies1 the availability of a draft 

guidance for industry entitled ‘‘Good 

Importer Practices.’’ This draft guidance 

is issued in response to 

recommendations contained in the 

Action Plan for Import Safety: A 

Roadmap for Continual Improvement 

(Action Plan) issued on November 6, 

2007, by the Interagency Working Group 

on Import Safety (Working Group) 

established by Executive Order 13439 

(see http://www.importsafety.gov/ 

report/actionplan.pdf). The Action Plan 

recommends that the Federal 

Government work with the importing 

community and other members of the 

public to develop Good Importer 

Practices and issue guidance. The 

Action Plan specifies that the focus of 

these practices should be to ensure that 

imported products meet U.S. standards, 

as well as to promote effective supplychain management. The Action Plan 

recommended that these practices be 

risk-based and provide concrete 

guidance to the importing community 

for evaluating imported products. This 

evaluation would be based on due 

diligence and preventive control 

principles. 

This guidance is intended for use by 

the importer that initiates or causes the 

entry or attempted entry of foreignsourced products into the United States 

or the reimportation of U.S.-made 

products (American goods returned) for 

commercial purposes to help ensure 

that such products are safe and comply 

with applicable U.S. requirements.2 At 

any point during the product’s life 

cycle, hazards can be introduced that 

may place consumers at risk unless 

appropriate preventive controls are 

implemented. In general, the 

recommendations advise the importer to 

know the foreign firms with whom they 

do business and through which the 

products they purchase pass, 

understand the products they import 

and their vulnerabilities, understand the 

hazards that may be introduced during 

the product life cycle, and ensure that 

these hazards have been properly 

controlled and monitored. Importers 

should consider instituting practices to 

identify and minimize risk. Importers 

should put into place controls for 

known vulnerabilities, such as to 

microbiological contamination or 

product defects, and monitor for other 

risks, such as counterfeiting or 

intentional contamination. 

These Good Importer Practices are 

broadly organized by four guiding 

principles. These four guiding 

principles are as follows: 

• Establishing a product safety 

management program 

• Knowing the product and 

applicable U.S. requirements 

• Verifying product and firm 

compliance with U.S. requirements 

throughout the supply chain and 

product life cycle 

• Taking corrective and preventive 

action when the imported product 

or firm is not compliant with U.S. 

Requirements 

The guidance suggests actions the 

importer can take to accomplish each of 

these objectives. 

This draft guidance is being issued 

consistent with the Office of 

Management and Budget’s Final 

Bulletin for Agency Good Guidance 

Practices (No. 07–02 (M–07–07)). The 

draft guidance, when finalized, will 

represent the agencies’ current thinking 

on Good Importer Practices. It does not 

create or confer any rights for or on any 

person and does not operate to bind the 

agencies or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable U.S. statutes and regulations. 

II. Comments 

FDA is coordinating the receipt of 

submitted comments on behalf of the 

agencies. Interested persons may submit 

to FDA’s 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. 

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. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/oc/guidance/ 

goodimportpractice.html or http:// 

www.regulations.gov. 

Dated: January 8, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–453 Filed 1–12–09; 8:45 am] 

BILLING CODE 4160–01–S