69314 Federal Register / Vol. 65, No. 222 / Thursday, November 16, 2000 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1604]

Agency Information Collection

Activities; Proposed Collection;

Comment Request; OTC Test Sample

Collection Systems for Drugs of Abuse

Testing

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

over-the-counter (OTC) test sample

collection systems for drugs of abuse

testing.

DATES: Submit written or electronic

comments on the collection of

information by January 16, 2001.

ADDRESSES: Submit electronic

comments on the collection of

information to http://

www.accessdata.fda.gov/scripts/oc/

dockets/edockethome.cfm. 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

documents should be identified with

the docket number found in brackets in

the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Peggy Schlosburg, Office of Information

Resources Management (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.

OTC Test Sample Collection Systems

for Drugs of Abuse Testing—21 CFR

Part 809 (OMB Control Number 0910–

0368)—Extension

FDA has reclassified OTC test sample

collection systems for drugs of abuse

testing from class III (premarket

approval) into class I (general controls)

subject to restrictions established in

accordance with section 520(e) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 360j).

The labeling requirements for certain

in vitro diagnostic products require that

manufacturers of OTC test sample

collection systems for drugs of abuse

testing provide certain information to

consumers for the proper use of the test

sample collection system and for

interpreting the results. The purpose of

this regulation is to ensure that lay

persons collecting samples for testing

have adequate instructions for sample

collection and handling and for

receiving and understanding the test

results reported by laboratories

performing the analyses.

The most likely respondents to this

information collection will be

manufacturers of over-the-counter drugs

of abuse test kits.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section No. of respondents Annual frequency per

response

Total annual

responses Hours per response Total hours

809.10 20 1 20 100 2,000

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

Based upon submissions to the agency

(premarket notifications, premarket

approval applications, registration and

listing), FDA estimates that there will be

about 20 manufacturers of these devices.

FDA estimates, based upon

discussions with manufacturers of

similar devices required to comply with

21 CFR 809.10, that it will take

approximately 40 hours to gather the

information required by the rule, 40

hours to design and prepare the

labeling, and an additional 20 hours per

year to review and revise the labeling as

necessary.

Dated: November 9, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–29326 Filed 11–15–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 96N–0393]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request;

MedWatch: The FDA Medical Products

Reporting Program

AGENCY: Food and Drug Administration,

HHS.

Federal Register / Vol. 65, No. 222 / Thursday, November 16, 2000 / Notices 69315

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995.

DATES: Submit written comments on the

collection of information by December

18, 2000.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Wendy

Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Mark L. Pincus, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1471.

SUPPLEMENTARY INFORMATION: In

compliance with 44 U.S.C. 3507, FDA

has submitted the following proposed

collection of information to OMB for

review and clearance.

MedWatch—The FDA Medical Products

Reporting Program (Forms FDA 3500

and FDA 3500A) (OMB Control Number

0910–02910)—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. 301),

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. Likewise for

cosmetics, the act does not give FDA the

authority to require manufacturers to

register their cosmetic establishments,

file data on ingredients, conduct safety

testing, or report cosmetic-related

injuries. Only postmarket surveillance

allows FDA to assess cosmetic problems

in the marketplace.

To carry out its responsibilities, the

agency needs to be informed whenever

an adverse event or product problem

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 actions ranging from

labeling changes to the rare product

withdrawal. 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, 606, and 803 (21 CFR

parts 310, 314, 600, 606, and 803),

specifically §§ 310.305, 314.80, 314.98,

600.14, 600.80, 606.170, 606.171,

803.30, 803.50, 803.53, and 803.56.

To implement these provisions for

reporting of adverse events and product

problems with human medications,

devices, and biologics, as well as any

other products that are regulated by

FDA, two very similar forms are used

(an exception is biologic product

deviation reports). Form FDA 3500 is

used for voluntary (i.e., not mandated

by law or regulation) reporting of

adverse events and product problems by

health professionals and the public.

Form FDA 3500A is used for mandatory

reporting (i.e., required by law or

regulation). New biologic regulations

§§ 600.14 and 606.171 require that

biologic product deviation reports,

which are similar to drug product

problem reports, be submitted to FDA

via a different form. Reports of fatalities

as a complication of blood collection or

transfusion are reported as per

§ 606.170.

Respondents to this collection of

information are health professionals,

hospitals and other user-facilities (e.g.,

nursing homes, etc.), consumers,

manufacturers of biologics, drugs and

medical devices, and importers.

I. Use of the Voluntary Version (FDA

Form 3500)

Individual health professionals are

not required by law or regulation to

submit adverse event or product

problem reports to the agency or the

manufacturer. There is one exception.

The National Childhood Injury Act of

1986 mandates that certain adverse

events following immunization be

reported by health care providers to the

joint FDA/Centers for Disease Control

and Prevention Vaccine Adverse Event

Reporting System (VAERS). Vaccine

reporting should be submitted on Form

VAERS–1 (FDA).

Hospitals are not required by Federal

law or regulation to submit adverse

event reports on medications. However,

hospitals and other medical facilities are

required by Federal law to report

medical device-related deaths and

serious injuries, biological product

deviation reports, and reports of

fatalities as a complication of blood

collection or transfusion.

Manufacturers of dietary supplements

do not have to prove safety or efficacy

of their products prior to marketing, nor

do they have mandatory requirements

for reporting adverse reactions to FDA.

However, the DSHEA puts the onus on

FDA to prove that a particular product

is unsafe. Likewise for cosmetics, the act

does not give FDA the authority to

require manufacturers to register their

cosmetic establishments, file data on

ingredients, conduct safety testing, or

report cosmetic-related injuries. Only

postmarket surveillance allows FDA to

assess cosmetic problems in the

marketplace. If a problem is detected, it

is up to the agency to demonstrate that

the product is harmful when used

according to label directions or under

customary conditions of use.

Consequently, the agency is totally

dependent on voluntary reporting by

health professionals and consumers

about problems with the use of dietary

supplements and cosmetics.

The voluntary version of the form is

used to submit all adverse event and

product problem reports not mandated

by Federal law or regulation.

II. Use of the Mandatory Version (FDA

Form 3500A)

A. Drug and Biologic Products

In section 505(j) and 704 of the act (21

U.S.C. 374), 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 (21 U.S.C. 372) 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

part 600 (biologics) of the Code of

Federal Regulations. Parts 310, 314, and

600 mandate the use of the FDA Form

3500A for reporting to FDA on adverse

events that occur with drugs and

biologics. Blood-related fatalities are

reported per § 606.170.

B. Medical Device Products

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

requires manufacturers or importers of

devices intended for human use to

establish and maintain records, make

reports, and provide information as the

Secretary of Health and Human Services

69316 Federal Register / Vol. 65, No. 222 / Thursday, November 16, 2000 / Notices

may by regulation reasonably require to

ensure that such devices are not

adulterated or misbranded and to

otherwise ensure its safety and

effectiveness. Furthermore, 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. FDA has

codified these statutory requirements

regarding mandatory reporting under

part 803. Part 803 mandates the use of

FDA Form 3500A for reporting to FDA

on medical devices.

C. Other Products Used in Medical

Therapy

There are no mandatory requirements

for the reporting of adverse events or

product problems with products such as

dietary supplements. However, the

DSHEA puts the onus on FDA to prove

that a particular product is unsafe.

Consequently, the agency is totally

dependent on voluntary reporting by

health professionals and consumers

about problems with the use of dietary

supplements. (Most pharmaceutical

manufacturers already use a one-page

modified version of the Form FDA

3500A where section G from the back is

substituted for section D on the front of

the form.)

D. Medical Device Baseline Information

The Medical Device Reporting form

(Form FDA 3417) relates specifically to

the individual device and must be

submitted with the first adverse event

on that device reported via Form FDA

3500A. The information collected

includes the basis for marketing (510(k),

PMA, etc.), product code for the device,

common name, location where

manufactured, and other identifying

information. The Health Industry

Manufacturers Association (HIMA) first

commented in 1992 on the redundancy

of information required for the Baseline

form stating that the information is also

collected by the agency though the

device listing process (Form FDA 2892)

and through Form FDA 3500A. In 1998,

HIMA commented again and, at the

request of OMB, FDA explored revising

Form FDA 3500A to include the

information required by the Baseline

form that is not collected through the

listing process.

In discussions with OMB it was

decided that FDA would not attempt to

revise Form FDA 3500A at this time, but

would proceed with collecting the

information required by the Baseline

form as a separate part of the device

listing process especially because some

of the information required by the

current Baseline form will be collected

in that listing as a change in the listing

regulations. Because the collection of

registration and listing information will

be through electronic means, the agency

envisions a menu option on the Internet

to facilitate the collection of the

remainder of Baseline information.

FDA has held stakeholder meetings

and discussed the new device

registration and listing system and using

the new device and listing system

electronic process as the vehicle for the

Baseline information collection at those

meetings.

The agency requested comments on

this proposed collection of information

in the Federal Register of July 26, 2000

(65 FR 45988).

FDA received comments from four

interested parties, but some comments

raised multiple concerns.

While the comments on the proposed

revisions to the form(s) were mainly

favorable, the agency has decided to not

revise either form at this time. This

decision reflects several concerns. The

financial burden that would be placed

on sponsors and others required to

report, and FDA if the forms underwent

revision, and the availability of other

avenues by which use of the voluntary

and mandatory forms can be optimized,

namely appropriate revision of

documents related to their completion.

One comment suggested more

detailed instructions for completing the

MedWatch form. The instructions for

the voluntary form 3500 were updated

and posted on the Internet in April 2000

and the instructions for 3500A were

extensively revised and posted May

2000 (http://www.fda.gov/medwatch/

report/instruc.htm). Regarding

voluntary reporting, updated

instructions for completing the 3500

form were posted on the MedWatch

homepage in December 1998 and April

2000. They are available by mail/fax

upon request. The revisions of both the

voluntary and mandatory instructions

for use were based on questions/

comments about adverse event/product

problem reporting received by the

agency over time. One main revision on

both forms was to include information

about reporting on reuse of medical

devices labeled for single use.

One comment suggested revising the

March 1992 guidelines to incorporate

MedWatch form use. FDA published a

revised guidance for industry entitled

‘‘Postmarketing Adverse Experience

Reporting for Human Drug and Licensed

Biological Products: Clarification of

What to Report,’’ in August 1997 (http:/

/www.fda.gov/cder/guidance/

1830fn1.pdf). In this guidance it states

that the agency is still considering

comments received in response to the

proposed Federal Register of October

27, 1994, and recommendations recently

developed by the International

Conference on Harmonization and plans

to propose additional amendments to its

postmarketing safety reporting

regulations. FDA also plans to prepare

a single consolidated guidance

document on this topic once the process

is concluded.

One comment suggested a FDA

industry-wide assessment of

consistency of MedWatch field use for

both devices and drugs. At this time a

formal assessment of the completion of

the forms is not planned. As stated

above, questions/comments about use of

the form and reporting have been

incorporated into the revised

instructions for use for both forms. This

issue can also be addressed in any new

proposed regulations or guidance

documents.

One comment suggested expanding

public education regarding

postmarketing events. The MedWatch

Office is in the process of developing

educational materials, primarily for

health professionals, to assist in the

overall effort to improve the quality of

MedWatch reports.

One comment was made about the

estimate of the ‘‘hours per response.’’

Because the 3500A is used for

mandatory reporting subject to different

regulations (i.e., 21 CFR 310.305,

312.32, 314.80, 600.80, and part 803),

this estimate for reporting burden is

limited to completing the form.

Estimates of the burden placed on userfacilities, importers and manufacturers

to investigate a report and compile the

necessary information would be

addressed in the final rules for those

regulations.

One comment suggested further

clarification of the August 1997

guidance for definitions of identifiable

patient and reporter. This topic is

currently being discussed in the World

Health Organization’s Council for

International Organizations of Medical

Sciences, Work Group 5.

One comment suggested focusing on

new or unusual events and to allow

reporting of known non-serious events

via line listing. This same commenter

suggested minimal data collection for

known and well-characterized cases.

These comments are addressed in the

August 1997 guidance for industry

entitled ‘‘Postmarketing Adverse

Federal Register / Vol. 65, No. 222 / Thursday, November 16, 2000 / Notices 69317

Experience Reporting for Human Drug

and Licensed Biological Products:

Clarification of What to Report.’’

One comment suggested adding a box

to the 3500A form to require drug

manufacturers to state the date the

report was forwarded to FDA. This is

currently required for medical device

reporting, but not for drugs and

biologics. However, all manufacturers

must report the date received by the

manufacturer on form 3500A, section

G4. Many large manufacturers have data

bases that contain the date the

information was received and the date

the report was sent to FDA. As a

surrogate, these two dates can be

compared to see if the company is

fulfilling its requirements under the

regulations. The agency can use its

regulatory discretion in deciding

whether or not action is warranted in

the case of delayed reports. What is of

greater concern is the failure to report

and that cannot be detected by adding

this information to the form. Given that

the goal is for both pharmaceutical and

medical device industries to submit the

majority of mandatory reports

electronically, it would present a

financial burden to revamp systems to

accommodate a paper form that will be

virtually obsolete in the future.

One comment suggested a ‘‘tick box

for a 30-day report,’’ for form 3500A. At

this time there is no requirement for a

30-day report.

As both the 3500 instructions and

3500A instructions can be updated

periodically based on questions/

comments from stakeholders and

statutory/regulatory changes, changing

the forms themselves is not seen as

necessary at this point.

At such time it is decided to

repropose revisions, FDA will consult

all interested parties for input into the

design.

FDA estimates the burden for this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1

FDA center(s) (21 CFR section) No. of respondents

Annual

frequency per

response

Total annual

responses

Hours per

response Total hours

CBER/CDER2

Form 3500 16,198 1 16,198 0.5 8,099

Form 3500A (310.305, 314.80,

314.98, and 600.80) 600 455.2 273,109 1 273,109

CDRH3

Form 3500 2,650 1 2,650 0.5 1,325

Form 3500A (part 803) 2,046 24 49,305 1 49,305

CFSAN4

Form 3500 550 1 550 0.5 275

Form 3500A 0 0 0 1 0

No mandatory requirements

Total Hours 332,113

Form 3500 9,699

Form 3500A 322,414

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

2 Center for Biologics Evaluation and Research/Center for Drug Evaluation and Research.

3 Center for Devices and Radiological Health.

4 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 calendar year 1999 reports and respondents.

As more medical products are

approved by the FDA and marketed, and

as knowledge increases regarding the

importance of notifying FDA when

adverse events and product problems

are observed, it is expected that more

voluntary reports will be submitted.

Conversely, with the current plans for

increasing electronic submissions it is

expected that the number of mandatory

reports will decrease.

Dated: November 9, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–29324 Filed 11–15–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1435]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request;

Substantial Evidence of Effectiveness

of New Animal Drugs

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995.

DATES: Submit written comments on the

collection of information by December

18, 2000.

ADDRESSES: Submit written comments

on the collection of information to

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Wendy

Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Denver Presley, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1472.

SUPPLEMENTARY INFORMATION: In

compliance with 44 U.S.C. 3507, FDA

has submitted the following proposed

collection of information to OMB for

review and clearance.