77256 Federal Register / Vol. 69, No. 247 / Monday, December 27, 2004 / Notices 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–4659.

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 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology.

Exports: Notification and 

Recordkeeping Requirements—21 CFR 

Part 1 (OMB Control Number 0910–

0482)—Extension

The total burden estimate of 43,214 is 

based on the number of notifications 

received by the relevant FDA centers in 

fiscal year 2004, or the last year the 

figures available.

The respondents to this information 

collection are exporters who have 

notified FDA of their intent to export 

unapproved products that may not be 

sold or marketed in the United States as 

allowed under section 801(e) of the 

Federal Food, Drug, and Cosmetic Act 

(the act) (21 U.S.C. 381). In general, the 

notification identifies the product being 

exported (e.g., name, description, and in 

some cases, country of destination) and 

specifies where the notification should 

be sent. These notifications are sent 

only for an initial export; subsequent 

exports of the same product to the same 

destination (or, in the case of certain 

countries identified in section 802(b) of 

the act (21 U.S.C. 382), to any of those 

countries would not result in a 

notification to FDA.

The recordkeepers to this information 

collection are exporters who export 

human drugs, biologics, devices animal 

drugs, foods and cosmetics that may not 

be sold in the United States to maintain 

records demonstrating their compliance 

with the requirements in section 

801(e)(1) of the act.

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 

1.101(d) through (e) 419 2.8 1164 17 19,788

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 

of Recordkeeping 

Total Annual 

Records 

Hours per Recordkeeper Total Hours 

1.101(b) through (c) 324 2.8 901 26 23,426

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

Dated: December 17, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–28137 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–0535]

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; MedWatch: Food 

and Drug Administration Medical 

Products Reporting Program

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 collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

revisions to Form FDA 3500 and Form 

FDA 3500A, (also known as MedWatch 

reporting forms). These forms are 

currently used to report to the agency 

about adverse events, product problems 

and medication/device use errors that 

occur with FDA regulated products, 

including drugs, biologicals, medical 

devices, special nutritional products, 

and cosmetics.

DATES: Submit written or electronic 

comments on the collection of 

information by February 25, 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 20857. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. Copies of 

Form FDA 3500 and Form FDA 3500A 

are available for public examination on 

Federal Register / Vol. 69, No. 247 / Monday, December 27, 2004 / Notices 77257

Internet at http://www.fda.gov/ohrms/

dockets or in the Division of Dockets 

Management (see ADDRESSES) between 9 

a.m. and 4 p.m., Monday through 

Friday. Submit written requests for 

single copies of the revised reporting 

forms, Form FDA 3500 and Form FDA 

3500A to MedWatch: FDA Safety 

Information and Adverse Event 

Reporting Program (HFD–410), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857. Send one 

self-addressed adhesive label to assist 

that office in processing your request.

FOR FURTHER INFORMATION CONTACT:

Karen L. Nelson, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1482.

SUPPLEMENTARY INFORMATION:

I. Background

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 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology.

MedWatch: FDA Medical Products 

Reporting Program, Form FDA 3500 

and Form FDA 3500A—(OMB Control 

Number 0910–0291)—Extension

Under sections 505, 512, 513, 515, 

and 903 of the Federal Food, Drug, and 

Cosmetic Act (the act); (21 U.S.C. 355, 

360b, 360c, 360e, and 393); and section 

351 of the Public Health Service Act (42 

U.S.C. 262), FDA has the responsibility 

to ensure the safety and effectiveness of 

drugs, biologics, and devices. Under 

section 502(a) of the act (21 U.S.C. 

352(a)), a drug or device is misbranded 

if its labeling is false or misleading. 

Under section 502(f)(1) of the act it is 

misbranded if it fails to bear adequate 

warnings, and under section 502(j), it is 

misbranded if it is dangerous to health 

when used as directed in its labeling.

Under section 4 of the Dietary 

Supplement Health and Education Act 

of 1994 (the DSHEA) (21 U.S.C. 341), 

section 402 of the act (21 U.S.C 342) is 

amended so that FDA must bear the 

burden of proof to show a dietary 

supplement is unsafe.

To carry out its responsibilities, the 

agency needs to be informed whenever 

an adverse event, product problem or 

error with use of a medication or device 

occurs. Only if FDA is provided with 

such information will the agency be able 

to evaluate the risk, if any, associated 

with the product, and take whatever 

action is necessary to reduce or 

eliminate the public’s exposure to the 

risk through regulatory action. To 

ensure the marketing of safe and 

effective products, certain adverse 

events must be reported. Requirements 

regarding mandatory reporting of 

adverse events or product problems 

have been codified in parts 310, 314, 

600, and 803 (21 CFR parts 310, 314, 

600, and 803), specifically §§ 310.305, 

314.80, 314.98, 600.80, 803.30, 803.50, 

803.53, and 803.56.

To implement these provisions for 

reporting of adverse events, product 

problems and medication/device use 

errors for FDA regulated products such 

as medications, devices, biologics, 

special nutritional products, and 

cosmetics, as well as any other products 

that are regulated by FDA, two forms are 

available from the agency. Form FDA 

3500 may be used for voluntary (i.e., not 

mandated by law or regulation) 

reporting by healthcare professionals 

and the public. Form FDA 3500A is 

used for mandatory reporting (i.e., 

required by law or regulation).

Respondents to this collection of 

information are healthcare 

professionals, hospitals and other userfacilities (e.g., nursing homes, etc.), 

consumers, manufacturers of biological 

and drug products or medical devices, 

and importers.

II. Use of Form FDA 3500 (Voluntary 

Version)

The voluntary version of the form is 

used to submit all reports not mandated 

by Federal law or regulation. Individual 

health professionals are not required by 

law or regulation to submit reports to 

the agency or the manufacturer, with the 

exception of certain adverse reactions 

following immunization with vaccines 

as mandated by the National Childhood 

Vaccine Injury Act of 1986. Those 

mandatory reports are not submitted to 

FDA on the 3500 or 3500A form, but are 

submitted to the joint FDA/Centers for 

Disease Control and Prevention 

Vaccines Adverse Event Reporting 

System (VAERS) on the VAERS–1 form. 

(See http://www.vaers.org/pdf/

vaerslfor.pdf.)

Hospitals are not required by Federal 

law or regulation to submit reports 

associated with drug products, 

biological products or special 

nutritional products. However, hospitals 

and other user facilities are required by 

Federal law to report medical devicerelated deaths and serious injuries.

Manufacturers of dietary supplements 

do not have mandatory requirements for 

reporting adverse reactions to FDA. The 

DSHEA puts the responsibility on FDA 

to prove that a particular product is 

unsafe. The agency depends on the 

voluntary reporting by health 

professionals and consumers of 

suspected adverse events associated 

with the use of dietary supplements.

III. Use of Form FDA 3500A 

(Mandatory Version)

A. Drug and Biologic Products

In sections 505(j) and 704 (21 U.S.C. 

374) of the act, Congress has required 

that important safety information 

relating to all human prescription drug 

products be made available to FDA so 

that it can take appropriate action to 

protect the public health when 

necessary. Section 702 of the act 

authorizes investigational powers to 

FDA for enforcement of the act. These 

statutory requirements regarding 

mandatory reporting have been codified 

by FDA under parts 310 and 314 (drugs) 

and 600 (biologics). Parts 310, 314, and 

600 mandate the use of FDA Form 

3500A form for reporting to FDA on 

adverse events that occur with drugs 

and biologics.

B. Medical Device Products

Section 519 of the act (21 U.S.C. 360i) 

requires manufacturers and importers, 

of devices intended for human use to 

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.