69604 Federal Register / Vol. 69, No. 229 / Tuesday, November 30, 2004 / Notices 

and agreement to provide for the 

physical, mental and financial wellbeing of an unaccompanied minor and 

the sponsor’s assurance to appear before 

immigration courts. To ensure the safety 

of the children, sponsors must undergo 

a background check. Suitable sponsors 

may be parents, close relatives, friends 

or entities concerned with the child’s 

welfare. In this Notice, ACF announces 

that it proposes to employ the use of 

several information collections for 

recording: (1) The Sponsor’s Agreement 

to Conditions of Release, which collects 

the sponsor’s affirmation to the terms of 

the release; (2) the Verification of 

Release, which collects the children’s 

affirmation to the terms of their release; 

(3) the Family Reunification Packet, 

which collects information related to 

the sponsor’s ability to provide for the 

physical, mental and financial wellbeing of the child(ren); and (4) the 

Authorization for Release of 

Information, which collects information 

to be utilized for a background check. 

Respondents: Potential sponsors of 

unaccompanied alien children and 

unaccompanied alien children in 

Federal custody.

ANNUAL BURDEN ESTIMATES

Instrument Number of

respondents 

Number of

responses per 

respondent 

Average

burden hours 

per response 

Total burden 

hours 

Sponsor’s Agreement ...................................................................................... 3,000 1 .166666 500 

Verification of Release ..................................................................................... 3,000 1 .166666 500 

Family Reunification Packet ............................................................................ 3,000 20 .05 3,000 

Authorization for Release of Information ......................................................... 3,000 12 .05 1,800 

Estimated Total Annual Burden 

Hours: 5,800. 

In compliance with the requirements 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. E-mail address: 

grjohnson@acf.hhs.gov. All requests 

should be identified by the title of the 

information collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication.

Dated: November 24, 2004. 

Robert Sargis, 

Reports Clearance Officer.

[FR Doc. 04–26379 Filed 11–29–04; 8:45 am] 

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0498]

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Medical Devices; 

Device Tracking

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 information 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 information 

collection requirements for tracking of 

medical devices.

DATES: Submit written or electronic 

comments on the collection of 

information by January 31, 2005.

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:

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 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 

Federal Register / Vol. 69, No. 229 / Tuesday, November 30, 2004 / Notices 69605

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology.

Medical Devices; Device Tracking—21 

CFR Part 821 (OMB Control Number 

0910–0442)—Extension

Section 211 of the Food and Drug 

Administration Modernization Act 

(FDAMA) (Public Law 105–115) became 

effective on February 19, 1998. It 

amended the previous medical device 

tracking provisions in section 519(e)(1) 

and (e)(2) of the Federal Food, Drug, and 

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

360i(e)(1) and (e)(2) that were added by 

the Safe Medical Devices Act of 1990 

(SMDA) (Public Law 101–629). Unlike 

the tracking provisions under SMDA, 

which required tracking for any device 

meeting certain criteria, FDAMA allows 

FDA discretion in applying tracking 

requirements to devices that meet 

certain criteria and provides that 

tracking requirements can be imposed 

only after FDA issues an order. In the 

Federal Register of February 8, 2002 (67 

FR 5943), FDA issued a final rule to 

conform existing tracking regulations to 

changes in tracking provisions effected 

by FDAMA (part 821 (21 CFR part 821)).

Current section 519(e)(1) of the act, as 

amended by FDAMA, provides that 

FDA may by order require a 

manufacturer to adopt a method of 

tracking a class II or class III device, if 

the device meets one of three criteria: 

(1) The failure of the device would be 

reasonably likely to have serious 

adverse health consequences; (2) the 

device is intended to be implanted in 

the human body for more than 1 year 

(referred to as a ‘‘tracked implant’’); or 

(3) the device is life-sustaining or lifesupporting (referred to as a ‘‘tracked l/

s-l/s device’’) and is used outside a 

device user facility.

Tracking information is collected to 

facilitate identifying the current location 

of tracked devices and patients 

possessing the devices, to the extent that 

patients permit the collection of 

identifying information. Manufacturers 

and, as necessary, FDA use the data to 

expedite the recall of distributed 

devices that are dangerous or defective, 

and to facilitate the timely notification 

of patients or licensed practitioners of 

the risks associated with the devices.

Respondents to this collection of 

information are manufacturers, 

importers, and distributors of tracked 

implants or tracked l/s-l/s devices used 

outside a device user facility. 

Distributors include multiple and final 

distributors, including hospitals.

The regulations include requirements 

for exemptions and variances; system 

and content requirements of tracking; 

obligations of persons other than device 

manufacturers, e.g., distributors; records 

and inspection requirements; 

confidentiality; and record retention 

requirements.

FDA estimates the burden of this 

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of Respondents Annual Frequency per 

Response 

Total Annual 

Responses 

Hours per Response Total Hours 

821.2 (also 821.30(e)) 4 1 4 12 48

821.25(a) 1 1 1 76 76

821.25(d) 22 1 22 2 44

821.30(a), (b) 17,000 72 1,222,725 0.1666 203,706

821.30(c)(2) 1 1 1 28 28

821.30(d) 17,000 15 259,186 0.1666 43,180

Total 247,082

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

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Recordkeeper Total Hours 

821.25(b) 229 46,260 10,593,433 0.2899 3,071,036

821.25(c) 229 1 229 63.0 14,430

821.25(c)(3) 229 1,124 257,454 0.2899 74,636

Total 3,160,102

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

The annual reporting burden hours to 

respondents for medical device tracking 

is estimated to be 247,082 hours, and 

recordkeeping burdens for respondents 

is estimated to be 3,160,102 hours. 

These numbers have been rounded up. 

The estimates cited in tables 1 and 2 of 

this document are based primarily upon 

the data and methods provided in FDAs 

1999 assessment entitled ‘‘A Cost 

Assessment of Medical Device 

Tracking.’’ Using implantation 

procedures from the National Center for 

Health Statistics, FDA applied a 2 

percent annual growth rate to estimate 

the number of procedures for tracked 

implant devices from 1997–2006. The 

assessment also used unit shipment data 

in combination with various growth 

rates to estimate annual/sales 

distribution for the tracked l/s-l/s 

devices over the same time period. 

Additionally, the assessment estimates 

the industry burden for developing and 

maintaining tracking systems for these 

devices from 1997–2006.

For the annual recordkeeping burden, 

the number of manufacturers subject to 

device tracking (229) is based on data 

from FDA’s manufacturers database. 

FDA issued tracking orders to 20 

additional manufacturers during the 

time period 2002–2004. Under 

§ 821.25(c), the additional 

manufacturers collectively bear a onetime burden of 10,560 hours to develop 

a device tracking system. FDA’s 

estimate of 17,000 distributor 

respondents contained in the 

assessment is derived from Dun & 

Bradstreet sources on medical 

equipment wholesalers, retailers, home 

care dealers, and rental companies. 

Health Forum, an American Hospital 

Association Company, provided 

statistics on hospitals.

69606 Federal Register / Vol. 69, No. 229 / Tuesday, November 30, 2004 / Notices 

Dated: November 19, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–26331 Filed 11–29–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0063]

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Voluntary Registration of Cosmetic 

Product Establishments

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Voluntary Registration of Cosmetic 

Product Establishments’’ has been 

approved by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995.

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: In the 

Federal Register of July 19, 2004 (69 FR 

43001), the agency announced that the 

proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. 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. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0027. The 

approval expires on November 30, 2007. 

A copy of the supporting statement for 

this information collection is available 

on the Internet at http://www.fda.gov/

ohrms/dockets.

Dated: November 19, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–26332 Filed 11–29–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004F–0455]

Sterigenics International, Inc.; Filing of 

Food Additive Petition

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that Sterigenics International, Inc., has 

filed a petition proposing that the food 

additive regulations be amended to 

provide for the safe use of ionizing 

radiation in the production of shelf 

stable foods, including multiple 

ingredient shelf stable foods.

FOR FURTHER INFORMATION CONTACT:

Lane A. Highbarger, Center for Food 

Safety and Applied Nutrition (HFS–

255), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740–3835, 301–436–1204.

SUPPLEMENTARY INFORMATION: Under the 

Federal Food, Drug, and Cosmetic Act 

(sec. 409(b)(5) (21 U.S.C. 348(b)(5))), 

notice is given that a food additive 

petition (FAP 3M4744) has been filed by 

Sterigenics International, Inc., P.O. Box 

17349, Memphis, TN 31817–0349. The 

petition proposes that the food additive 

regulations in part 179 Irradiation in the 

Production, Processing and Handling of 

Food (21 CFR 179) be amended to 

provide for the safe use of ionizing 

radiation in the production of fully 

cooked shelf stable foods, including 

fully cooked multiple ingredient shelf 

stable foods, where the absorbed dose 

required to cause a 12-log reduction in 

Clostridium botulinum has been 

established.

The agency has determined under 21 

CFR 25.32(j) that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required.

Dated: October 28, 2004.

Laura M. Tarantino,

Deputy Director, Office of Food Additive 

Safety, Center for Food Safety and Applied 

Nutrition.

[FR Doc. 04–26334 Filed 11–29–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D–0383]

Guidance for Industry and Food and 

Drug Administration Staff; Use of 

Symbols on Labels and in Labeling of 

In Vitro Diagnostic Devices Intended 

for Professional Use; Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Use of Symbols on Labels and in 

Labeling of In Vitro Diagnostic Devices 

Intended for Professional Use.’’ This 

document provides guidance on the use 

of selected symbols from international 

standards already recognized by FDA in 

place of text to convey some of the 

information required for in vitro 

diagnostic devices (IVDs) intended for 

professional use by FDA’s labeling 

requirements for IVDs.

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 ‘‘Use of 

Symbols on Labels and in Labeling of In 

Vitro Diagnostic Devices Intended for 

Professional Use’’ 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 self-addressed 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:

Paula G. Silberberg, Center for Devices 

and Radiological Health (HFZ–230), 

Food and Drug Administration, 1350 

Piccard Dr., Rockville, MD 20850, 301–

594–1217; or Sheryl A. Kochman, 

Center for Biologics Evaluation and