63156 Federal Register / Vol. 69, No. 209 / Friday, October 29, 2004 / Notices 

provides scientific and technical 

support to the operation and regulatory 

responsibilities of the Division; and (13) 

provides liaison and coordination of 

efforts with counterparts in other 

divisions and centers of CDC, as well as 

national and international agencies 

involved in addressing and preventing 

infectious diseases among globally 

mobile populations. 

Geographic Medicine and Health 

Promotion Branch (CR24). (1) Through 

the GeoSentinel Network develops 

geographic-specific infectious disease 

risk profiles among mobile populations; 

(2) coordinates and provides 

immunization data and recommends 

appropriate and effective intervention 

and prevention strategies to decrease 

morbidity and mortality among 

international travelers; (3) develops and 

issues vaccination documents and 

validation stamps in accordance with 

the International Health Regulations; (4) 

conducts surveillance for and assists in 

investigations of adverse events 

following administration of traveler 

vaccines; (5) alerts appropriate diseasespecific CDC programs about possible 

imported cases if disease and supports 

the relevant program to investigate these 

events; (6) monitors and analyzes 

reports of health threats overseas and 

issues travel notices, alerts and advisors 

when appropriate; (7) notifies the World 

Health Organization of the incidence of 

quarantinable diseases in the United 

States, as required by the International 

Health Regulations; (8) inspects 

shipments of nonhuman primates to 

ensure compliance with CDC 

regulations regarding quarantine, 

conditions of shipment and 

occupational safety and health of 

employees exposed to primates; (9) 

works to decrease the risk of importing 

zoonotic diseases of public health 

significance to humans via animals and 

cargo; (10) performs epidemiologic 

investigations and scientific research 

projects among U.S. travelers and 

imported animals; (11) periodically 

conducts active surveillance for 

infectious diseases among imported 

animals; (12) provides scientific and 

technical support to the operation and 

regulatory responsibilities of the 

Division; and (13) provides liaison and 

coordination of efforts with counterparts 

in other divisions of CDC, state and 

local health authorities, the travel 

industry, as well as national and 

international agencies involved in 

addressing and preventing infectious 

diseases among international travelers 

and translocated animals.

Dated: October 19, 2004. 

William H. Gimson, 

Chief Operating Officer, Centers for Disease 

Control and Prevention (CDC).

[FR Doc. 04–24213 Filed 10–28–04; 8:45 am] 

BILLING CODE 4160–18–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0436]

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request; Medical Device 

Registration and Listing

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 information 

collection, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

information collection requirements for 

medical device registration and listing.

DATES: Submit written and electronic 

comments on the collection of 

information by December 28, 2004.

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 Dockets Management 

Branch (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:

Peggy Robbins, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1223.

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: (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.

Medical Device Registration and 

Listing—21 CFR Parts 807.22, 807.31, 

and 807.40 (OMB Control No. 0910–

0387—Extension)

Section 510 of the Federal Food, Drug, 

and Cosmetic Act (the act) (21 U.S.C. 

360) requires domestic establishments 

engaged in the manufacture, 

preparation, propagation, compounding, 

assembly, or processing of medical 

devices intended for human use and 

commercial distribution register their 

establishments and list the devices they 

manufacture with FDA. This is 

accomplished by completing FDA Form 

2891 ‘‘Registration of Device 

Establishment’’ and FDA Form 2892 

‘‘Medical Device Listing.’’ The term 

‘‘device’’ is defined in section 201(h) of 

the act (21 U.S.C. 321) and includes all 

in vitro diagnostic products and in vitro 

diagnostic biological products not 

subject to licensing under section 351 of 

the Public Health Service Act (42 U.S.C. 

262). The FDA Modernization Act of 

1997 (FDAMA) added a requirement for 

foreign establishments to appoint a 

United States agent and submit the 

information to FDA on Form 2891 as 

part of its initial and updated 

registration information. In addition, 

each year, active, registered 

establishments must notify FDA of 

changes to the current registration and 

Federal Register / Vol. 69, No. 209 / Friday, October 29, 2004 / Notices 63157

device listing for the establishment. 

Annual changes to current registration 

information are preprinted on FDA 

Form 2891a and sent to registered 

establishments. The form must be sent 

back to FDA’s Center for Devices and 

Radiological Health, even if no changes 

have occurred. Changes to listing 

information are submitted on Form 

2892.

Under § 807.31 (21 CFR 807.31), each 

owner or operator is required to 

maintain an historical file containing 

the labeling and advertisements in use 

on the date of initial listing, and in use 

after October 10, 1978, but before the 

date of initial listing. The owner or 

operator must maintain in the historical 

file any labeling or advertisements in 

which a material change has been made 

anytime after initial listing, but may 

discard labeling and advertisements 

from the file 3 years after the date of the 

last shipment of a discontinued device 

by an owner or operator. Along with the 

recordkeeping requirements above, the 

owner or operator must be prepared to 

submit to FDA all labeling and 

advertising mentioned above 

(§ 807.31(e)).

Section 807.40 describes the role of 

the United States agent. The U.S. agent 

must reside or have a physical place of 

business in the United States, and each 

foreign establishment must submit U. S. 

agent information as part of its initial 

and updated registration process.

The information collected through 

these provisions is used by FDA to 

identify firms subject to FDA’s 

regulations and is used to identify 

geographic distribution in order to 

effectively allocate FDA’s field 

resources for these inspections and to 

identify the class of the device that 

determines the inspection frequency. 

When complications occur with a 

particular device or component, 

manufacturers of similar or related 

devices can be easily identified.

The likely respondents to this 

information collection will be domestic 

and foreign device establishments and 

U.S. agents who must register and 

submit a device list to FDA (e.g., 

establishments engaged in the 

manufacture, preparation, propagation, 

compounding, assembly, or processing 

of medical devices intended for human 

use and commercial distribution).

FDA estimates the burden of this 

collection of information as follows:

ESTIMATED ANNUAL REPORTING BURDEN

TABLE 1A.—ESTIMATED YEAR 1 ANNUAL REPORTING BURDEN1

21 CFR Section FDA Form No. 

No. of

Respondents

Annual Frequency of Response Total Annual

Responses

Hours per

Response Total Hours 

807.22(a) and 

807.40

2891 

Establishment of Registration

2,900 1 2,900 .25 725

807.22(b) 2892 Medical Device Listing4,400 1 4,400 .50 2,200

807.22(a) and 

807.40

2891a Annual Registration of 

Medical Device Establishment

25,100 1 25,100 .25 6,275

807.31(e) 200 1 200 .50 100

Total Year 1 

Burden Hours

9,300

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

TABLE 1B.—ESTIMATED SUBSEQUENT YEARS ANNUAL REPORTING BURDEN1

21 CFR Section FDA Form No. 

No. of

Respondents

Annual Frequency of Response Total Annual

Responses

Hours Per

Response Total Hours 

807.22(a) and 

807.40

2891 Registration of 

Establishment

3,100 1 3,100 .25 775

807.22(b) 2892 Medical Device Listing4,600 1 4,600 .50 2,300

807.22(a) and 

807.40

2891a Annual Registration of 

Medical Device Establishment

25,100 1 25,100 .25 6,275

807.31(e) 200 1 200 .50 100

Total Year 2 

and 3 Burden 

Hours

9,450

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

63158 Federal Register / Vol. 69, No. 209 / Friday, October 29, 2004 / Notices 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of Recordkeepers Annual Frequency 

per Recordkeeper Total Annual Records Hours Per Recordkeeper Total Hours 

807.31 16,200 4 64,800 .50 32,400

Total Burden Hours 32,400

1The burdens are explained as follows:

The annual reporting burden hours to 

respondents for registering 

establishments and listing devices is 

estimated to be 9,450 hours, and 

recordkeeping burden hours for 

respondents is estimated to be 32,400 

hours. The estimates cited in the tables 

above are based primarily upon the 

annual FDA accomplishment report, 

which includes actual FDA registration 

and listing figures from fiscal year (FY) 

2003. These estimates are also based on 

FDA estimates of FY 2003 data from 

current systems, conversations with 

industry and trade association 

representatives, and from internal 

review of the documents referred to in 

the previous tables.

According to 21 CFR part 807, all 

owners/operators are required to list, 

and establishments and U.S. agents are 

required to register. Each owner/

operator has an average of two 

establishments, according to statistics 

gathered from FDA’s registration and 

listing database. The database has 

25,100 active establishments listed in it. 

Based on past experience, the agency 

anticipated that approximately 7,300 

registrations will be processed during 

the first year, and 3,100 thereafter. FDA 

anticipates reviewing 200 historical files 

annually.

Dated: October 22, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–24192 Filed 10–28–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

Neurological Devices Panel of the 

Medical Devices Advisory Committee; 

Notice of Meeting

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). At least one portion of the 

meeting will be closed to the public.

Name of Committee: Neurological 

Devices Panel of the Medical Devices 

Advisory Committee.

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues.

Date and Time: The meeting will be 

held on November 30, 2004, from 8 a.m. 

to 5 p.m.

Location: Hilton Washington DC 

North/Gaithersburg, Salons A, B, and C, 

620 Perry Pkwy., Gaithersburg, MD.

Contact Person: Janet L. Scudiero, 

Center for Devices and Radiological 

Health (HFZ–410), Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850, 301–594–1184, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area), code 

3014512513. Please call the Information 

Line for up-to-date information on this 

meeting.

Agenda: The committee will discuss, 

make recommendations, and vote on 

premarket approval application for a 

device intended for use as an adjunct to 

sutured dural repair during cranial 

surgery to provide watertight closure. 

Background information for the topic, 

including the agenda and questions for 

the committee, will be available to the 

public 1 business day before the 

meeting on the Internet at http://

www.fda.gov/cdrh/panelmtg.html.

Procedure: On November 30, 2004, 

from 8:30 a.m. to 5 p.m., the meeting 

will be open to the public. Interested 

persons may present data, information, 

or views, orally or in writing, on issues 

pending before the committee. Written 

submissions may be made to the contact 

person by November 9, 2004. Oral 

presentations from the public will be 

scheduled for approximately 30 minutes 

at the beginning of committee 

deliberations and for approximately 30 

minutes near the end of the 

deliberations. Time allotted for each 

presentation may be limited. Those 

desiring to make formal oral 

presentations should notify the contact 

person before November 9, 2004, and 

submit a brief statement of the general 

nature of the evidence or arguments 

they wish to present, the names and 

addresses of proposed participants, and 

an indication of the approximate time 

requested to make their presentation.

Closed Committee Deliberations: On 

November 30, 2004, from 8 a.m. to 8:30 

a.m., the meeting will be closed to 

permit FDA to present to the committee 

trade secret and/or confidential 

commercial information (5 U.S.C. 

552b(c)(4)) relating to pending issues 

and applications.

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets.

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact AnnMarie 

Williams, Conference Management 

Staff, at 301–594–1283, ext. 113 at least 

7 days in advance of the meeting.

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2).

Dated: October 22, 2004.

Sheila Dearybury Walcoff,

Associate Commissioner for External 

Relations.

[FR Doc. 04–24191 Filed 10–28–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D–0453]

Draft Revised Compliance Policy 

Guide ‘‘Sec. 560.400—Imported Milk 

and Cream—Federal Import Milk Act 

(CPG 7119.05);’’ Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft revision of the 

compliance policy guide (CPG) entitled 

‘‘Sec. 560.400—Imported Milk and 

Cream—Federal Import Milk Act.’’ The 

draft CPG provides guidance on the