51864 Federal Register / Vol. 74, No. 194 / Thursday, October 8, 2009 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0438] 

Guidance for Industry and Food and 

Drug Administration Staff; 

Implementation of Medical Device 

Establishment Registration and Device 

Listing Requirements Established by 

the Food and Drug Administration 

Amendments Act of 2007; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Implementation of Medical Device 

Establishment Registration and Device 

Listing Requirements Established by the 

Food and Drug Administration 

Amendments Act of 2007.’’ The purpose 

of this guidance is to explain recent 

changes in the device registration and 

listing program to owner/operators and 

official correspondents of device 

establishments and to help them fulfill 

these new requirements. The guidance 

also describes the information that 

owner/operators of device 

establishments must submit to register 

their establishments and list their 

devices electronically, using FDA Form 

No. 3673. Those owner/operators 

seeking a waiver from the electronic 

submission requirement must submit 

their requests in writing to FDA with a 

complete explanation of why their 

registration and listing information 

cannot reasonably be submitted 

electronically. This guidance document 

is immediately in effect, but it remains 

subject to comment in accordance with 

the agency’s good guidance practices 

(GGPs). 

DATES: Submit written or electronic 

comments on this guidance at any time. 

General comments on agency guidelines 

are welcome at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance document 

entitled ‘‘Implementation of Medical 

Device Establishment Registration and 

Device Listing Requirements 

Established by the Food and Drug 

Administration Amendments Act of 

2007’’ to the Division of Small 

Manufacturers, International, and 

Consumer Assistance, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, rm. 4613, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request, or fax your request to 301–847– 

8149. 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.regulations.gov. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

David Racine, Center for Devices and 

Radiological Health (HFZ–410), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, rm. 2672, 

Silver Spring, MD 20993–0002, 301– 

796–5777. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In October 2002, section 510 of the 

Federal Food, Drug, and Cosmetic Act 

(the act) (21 U.S.C. 360) was amended 

by section 207 of the Medical Device 

User Fee and Modernization Act of 2002 

(Public Law 107–250) to add a 

requirement for electronic submission of 

registration information. On September 

27, 2007, the Food and Drug 

Administration Amendments Act of 

2007 (FDAAA) (Public Law–110–85) 

further amended the device registration 

and listing provisions in section 510 of 

the act and also added provisions to 

sections 737 and 738 of the act (21 

U.S.C. 379i and 379j) to require certain 

types of device establishments to pay 

user fees in connection with their initial 

or annual registration beginning on 

October 1, 2007. As amended, section 

510(p) of the act now requires all device 

establishments to submit their device 

registration and listing information by 

electronic means unless FDA grants 

their request for a waiver. 

The guidance described in this 

document explains the new, electronic 

process for registration and listing using 

the Internet and the process for 

requesting a waiver from FDA. In 

addition, the guidance specifies the user 

fee amounts for each fiscal year (FY) 

through FY 2012. 

FDAAA imposes new requirements 

on device establishments to submit their 

registration and listing information to 

FDA through electronic means and to 

pay user fees in connection with their 

registration beginning on October 1, 

2007. FDAAA was signed into law 

September 27, 2007. Because the law 

was immediately in effect, FDA 

determined that it was not feasible to 

obtain public participation prior to 

implementing the new FDAAA 

requirements described in this 

guidance. Therefore, in accordance with 

FDA’s GGP procedures at 21 CFR 

10.115(g)(2), FDA is issuing this as a 

level 1 guidance that is immediately in 

effect and will accept comments on the 

guidance at any time. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s GGPs regulation 

(21 CFR 10.115). The guidance 

represents the agency’s current thinking 

on this topic. 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 

Persons interested in obtaining a copy 

of the guidance may do so by using the 

Internet. To receive ‘‘Implementation of 

Medical Device Establishment 

Registration and Device Listing 

Requirements Established by the Food 

and Drug Administration Amendments 

Act of 2007,’’ you may either send an email request to dsmica@fda.hhs.gov to 

receive an electronic copy of the 

document or send a fax request to 301– 

847–8149 to receive a hard copy. Please 

use the document number (1657) to 

identify the guidance you are 

requesting. 

CDRH maintains a web site 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 

at http://www.regulations.gov. 

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 (44 U.S.C. 3501– 

3520). The collections of information in 

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Federal Register / Vol. 74, No. 194 / Thursday, October 8, 2009 / Notices 51865 

this guidance were approved under 

OMB control number 0910–0625. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on this guidance 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 30, 2009. 

Jeffrey Shuren, 

Acting Director, Center for Devices and 

Radiological Health. 

[FR Doc. E9–24349 Filed 10–7–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; 

Cancellation of Meeting 

Notice is hereby given of the 

cancellation of the Center for Scientific 

Review Special Emphasis Panel, 

October 23, 2009, 8 a.m. to October 23, 

2009, 12 p.m., InterContinental Mark 

Hopkins San Francisco, One Nob Hill, 

999 California Street, San Francisco, 

CA, 94108 which was published in the 

Federal Register on September 25, 2009, 

74 FR 48979. 

The meeting was cancelled due to 

administration problems. 

Dated: October 1, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–24278 Filed 10–7–09; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; 

Neuroprotection and Neurodegeneration. 

Date: October 27–28, 2009. 

Time: 8 a.m. to 11:59 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Virtual Meeting). 

Contact Person: Peter B. Guthrie, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4142, 

MSC 7850, Bethesda, MD 20892, (301) 435– 

1239, guthriep@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; 

Biobehavioral Regulation, Learning and 

Ethology. 

Date: October 27, 2009. 

Time: 10 a.m. to 8 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Virtual Meeting). 

Contact Person: Cheri Wiggs, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3180, 

MSC 7848, Bethesda, MD 20892, (301) 435– 

1261, wiggs@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Cancer 

Diagnostics and Therapeutics SBIR/STTR. 

Date: October 29–30, 2009. 

Time: 9 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Virtual Meeting). 

Contact Person: Lambratu Rahman, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6214, 

MSC 7804, Bethesda, MD 20892, 301–451– 

3493, rahmanl@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Signaling 

and DNA Repair. 

Date: October 29, 2009. 

Time: 9 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Virtual Meeting). 

Contact Person: Manzoor Zarger, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6208, 

MSC 7804, Bethesda, MD 20892, (301) 435– 

2477, zargerma@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Tooth 

Development. 

Date: October 29, 2009. 

Time: 3 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Telephone Conference Call). 

Contact Person: Priscilla B. Chen, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4104, 

MSC 7814, Bethesda, MD 20892, (301) 435– 

1787, chenp@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Vascular 

Biology. 

Date: October 30, 2009. 

Time: 7 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites Hotel at the Chevy 

Chase Pavilion, 4300 Military Road, NW., 

Washington, DC 20015. 

Contact Person: Bukhtiar H. Shah, DVM, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4120, 

MSC 7802, Bethesda, MD 20892, (301) 435– 

1233, shahb@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Research 

Resource Review. 

Date: November 1–3, 2009. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Best Western Boston—The Inn at 

Longwood Medical, 342 Longwood Avenue, 

Boston, MA 02115. 

Contact Person: Lee Rosen, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5116, 

MSC 7854, Bethesda, MD 20892, (301) 435– 

1171, rosenl@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Drug 

Discovery for Neurodegenerative Diseases 

and Drug Abuse. 

Date: November 3–4, 2009. 

Time: 11 a.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Virtual Meeting). 

Contact Person: Geoffrey G. Schofield, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4040–A, 

MSC 7850, Bethesda, MD 20892, 301–435– 

1235, geoffreys@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Synchrotron 

Structural Biology Resource. 

Date: November 3–5, 2009. 

Time: 6 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Stanford Park Hotel, 100 El Camino 

Real, Menlo Park, CA 94025. 

Contact Person: Nuria E. Assa-Munt, Ph.D., 

Scientific Review Officer, Center for 

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