77258 Federal Register / Vol. 69, No. 247 / Monday, December 27, 2004 / Notices 

establish and maintain records, make 

reports, and provide information as the 

Secretary of Health and Human Services 

may by regulation reasonably require to 

assure that such devices are not 

adulterated or misbranded and to 

otherwise assure its safety and 

effectiveness. The Safe Medical Device 

Act of 1990, signed into law on 

November 28, 1990, amends section 519 

of the act. The amendment requires that 

user facilities such as hospitals, nursing 

homes, ambulatory surgical facilities, 

and outpatient treatment facilities report 

deaths related to medical devices to 

FDA and to the manufacturer, if known. 

Serious illnesses and injuries are to be 

reported to the manufacturer or to FDA 

if the manufacturer is not known. These 

statutory requirements regarding 

mandatory reporting have been codified 

by FDA under part 803. Part 803 

mandates the use of FDA Form 3500A 

for reporting to FDA on medical 

devices.

The Medical Device User Fee and 

Modernization Act of 2002 (MDUFMA), 

Public Law 107–250, signed into law 

October 26, 2002, amended section 519 

of the act. The amendment (section 303 

of MDUFMA) required FDA to revise 

the MedWatch forms ‘‘to facilitate the 

reporting of information . . . relating to 

reprocessed single-use devices, 

including the name of the reprocessor 

and whether the device has been 

reused.’’

IV. Proposed Modifications to Forms

The proposed modifications to Form 

FDA 3500 and Form FDA 3500A reflect 

changes that will bring the form into 

conformation with current regulations, 

rules, and guidances. Modifications 

were also made to better reflect the 

range of reportable products and 

language was changed slightly to 

provide clarity. The changes should 

allow reporters to better utilize available 

space for data entry and offer voluntary 

reporters the opportunity to better 

characterize the suspected adverse 

event, product problem or error and 

provide better quality safety-related data 

for agency evaluation.

In the proposed modification to 

current section D, Suspect Medical 

Device, the agency has relettered the 

form section and modified the 

formatting slightly, moving two of the 

data elements (‘‘Device available for 

evaluation’’ and ‘‘Concomitant medical 

products’’) to adjacent lettered sections 

on the form in order to improve the 

utilization of available space and allow 

for information on non-device products 

to share these data fields. The agency 

believes that these changes are 

compatible with the mandatory 

reporting instructions for devices 

(§ 803.33) and will allow mandatory 

reporters to continue to meet their 

reporting requirements.

FDA estimates the burden for 

completing the forms for this collection 

of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 

FDA Center/21 CFR Section No. of Respondents 

Annual Frequency per 

Response 

Total 

Annual 

Responses 

Hours per Response Total Hours 

CBER/CDER 

Form 3500 22,955 1 22,955 0.6 13,773

Form 3500A (§§ 310.305, 314.80, 314.98, 600.80) 600 579.9 347,940 1.1 382,734

CDRH 

Form 3500 3,433 1 3,433 0.6 2,060

Form 3500A (Part 803) 1,935 33 63,623 1.0 63,623

CFSAN 

Form 3500 847 1 847 0.6 508

Form 3500A (No Mandatory Requirements) 0 0 0 0 0

Total Hours 462,698

Form 3500 16,341

Form 3500A 446,357

(NOTE: CBER = Center for Biologics Evaluation and Research; CDER = Center for Drug Evaluation and Research; CDRH = Center for Devices and Radiological Health; and CFSAN = Center for Food Safety and Applied Nutrition). FDA Form 3500 is for voluntary reporting; FDA Form 

3500A is for mandatory reporting).

The figures shown in table 1 of this 

document are based on actual fiscal year 

2003 reports and respondents for each 

center and type of report.

Dated: December 17, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–28138 Filed 12–23–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0454]

Dietary Supplements; Premarket 

Notification for New Dietary Ingredient 

Notifications; Reopening of Comment 

Period

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice; reopening of comment 

period.

SUMMARY: The Food and Drug 

Administration (FDA) is reopening to 

February 1, 2005, the comment period 

for a notice that appeared in the Federal 

Register of October 20, 2004 (69 FR 

61680). In the notice, FDA solicited 

comments on FDA’s premarket 

notification program for new dietary 

ingredients (NDIs) and announced a 

public meeting on that topic. The 

comment period closed on December 3, 

2004. FDA is reopening the comment 

period in response to a request from 

trade associations representing firms in 

the dietary supplement industry for 

additional time to submit comments.

DATES: Submit written or electronic 

comments by February 1, 2005.

Federal Register / Vol. 69, No. 247 / Monday, December 27, 2004 / Notices 77259

ADDRESSES: Submit written comments 

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.

FOR FURTHER INFORMATION CONTACT:

Kelly Williams-Randolph, Center for 

Food Safety and Applied Nutrition 

(HFS–810), Food and Drug 

Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740, 301–

436–2506, FAX: 301–436–2639, or email: Kelly.Williams@cfsan.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of October 20, 

2004, FDA published a notice 

announcing a public meeting on 

November 15, 2004, and soliciting 

comments on FDA’s premarket 

notification program for NDIs with an 

opportunity for public comment for 45 

days. FDA requested comments from 

industry, consumers, and other 

interested members of the public 

concerning the content and format 

requirements for NDI notifications made 

under section 413(a)(2) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

350b(a)(2)). FDA held this meeting to 

give the public an opportunity to 

provide information and views on 

topics outlined in the notice. The 

agency intends to consider all 

comments received in the meeting and 

sent to the docket in determining 

whether any future action is necessary 

or appropriate.

The agency has received a request 

from a number of trade associations for 

an extension of the comment period to 

and including February 1, 2005. The 

request set forth several reasons in 

support of allowing additional time to 

submit comments. First, according to 

the request, the 45-day comment period 

did not allow sufficient time for 

interested parties to adequately address 

the large number of detailed and 

specific questions put forth by FDA and 

the significant impact on industry, 

especially small businesses, of the 

issues raised in the notice. The request 

noted that the questions (many of which 

contained subparts) will require 

extended industry discussion to ensure 

broad input from member firms and to 

organize the information obtained from 

their member companies. Second, the 

request noted that the original December 

3, 2004, deadline for submitting 

comments did not provide interested 

parties enough time to consider the 

transcript of the November 15, 2004, 

meeting in developing their comments. 

The request explained that an extension 

until February 1, 2005, would allow 

industry to submit more focused and 

detailed comments without significantly 

delaying the agency’s consideration of 

the issues set forth in the meeting 

notice.

FDA has considered the request and 

is reopening the comment period for the 

October 20, 2004, notice until February 

1, 2005. The agency agrees that 

reopening the comment period will 

allow adequate time for interested 

persons to submit comments without 

significantly delaying the agency’s 

consideration of the issues set forth in 

the October 20, 2004, notice.

II. Request for Comments

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding the issues raised in 

the October 20, 2004, notice. 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: December 17, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–28135 Filed 12–23–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HOMELAND 

SECURITY 

Directorate of Information Analysis 

and Infrastructure Protection (IAIP) 

[DHS–2004–0032] 

Open Meeting of National 

Infrastructure Advisory Council (NIAC)

AGENCY: Directorate of Information 

Analysis and Infrastructure Protection, 

DHS.

ACTION: Notice of meeting.

SUMMARY: The National Infrastructure 

Advisory Council (NIAC) will meet on 

Tuesday, January 11, 2005, from 1 p.m. 

to 4 p.m. at the Hamilton Crowne Plaza 

in Washington, DC. The meeting will be 

open to the public. Limited seating will 

be available. Reservations are not 

accepted. 

The NIAC advises the President of the 

United States on the security of critical 

infrastructures which include banking 

and finance, transportation, energy, 

manufacturing, and emergency 

government services. At this meeting, 

the NIAC will be briefed on the status 

of several Working Group activities that 

the Council undertook at its last 

meeting.

DATES: The NIAC will meet Tuesday, 

January 11, 2005, from 1 p.m. to 4 p.m.

ADDRESSES: The NIAC will meet at the 

Hamilton Crowne Plaza, 14th and K 

Street, NW., Washington, DC. You may 

submit comments, identified by DHS 

Docket DHS–2004–0032 by one of the 

following methods: 

• EPA Federal Partner EDOCKET 

Web Site: http://www.epa.gov/

feddocket. Follow the instructions for 

submitting comments on the Web site. 

• Federal eRulemaking Portal: http://

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail/Hand Delivery/Courier: 

Department of Homeland Security, Attn: 

Ms. Nancy J. Wong, Infrastructure 

Coordination Division, Directorate of 

Information Analysis and Infrastructure 

Protection/703–235–5352, Anacostia 

Navel Annex, 245 Murray Lane, SW., 

Building 410, Washington, DC 20528, 

7:30 a.m. to 4 p.m. 

Instructions: All submissions received 

must include the DHS–2004–0032. All 

comments received will be posted 

without change to http://www.epa.gov/

feddocket, including any personal 

information provided.

FOR FURTHER INFORMATION CONTACT:

Nancy J. Wong, NIAC Designated 

Federal Official, telephone 703–235–

5352.

SUPPLEMENTARY INFORMATION: Notice of 

these meetings is given under the 

Federal Advisory Committee Act, 5 

U.S.C. App. 2.

AGENDA OF COMMITTEE MEETING ON JANUARY 11, 2005 

I. Opening of Meeting ..................... Nancy J. Wong, U.S. Department of Homeland Security (DHS)/Designated Federal Officer, NIAC. 

II. Roll Call of Members .................. Nancy J. Wong. 

III. Opening Remarks and Introductions.NIAC Chairman, Erle A. Nye, Chairman of the Board, TXU Corporation. 

NIAC Vice Chairman, John T. Chambers, Chairman and CEO, Cisco Systems, Inc.