Agency Information Collection Activities; Submission for OMB Review; Comment Request; MedWatch: The FDA Medical Products Reporting Program

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.

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 (the PRA).

DATES: Submit written comments on the collection of information by

October 20, 1999.

ADDRESSES: Submit written comments on the collection of information to

the Office of Information and Regulatory Affairs, OMB, New Executive

Office Building, 725 17th St. NW., rm. 10235, Washington, DC 20503,

Attn: 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 section 3507 of the PRA

(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 0910-0291)--Extension

Under sections 505, 512, 513, 515, and 903 of the Federal Food,

Drug, and

[[Page 50821]]

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), 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 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 regulatory

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, 312, 314, 600, and 803 (21 CFR parts 310, 312,

314, 600, and 803), specifically Secs. 310.305, 312.32, 312.33, 314.80,

314.98, 600.80, 803.30, 803.50, 803.53, and 803.56.

To implement these provisions for reporting of adverse events and

product problems with all medications, devices, and biologics, as well

as any other products that are regulated by FDA, two very similar forms

are used. 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). 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, distributors,

and importers.

I. Use of the Voluntary Version (Form FDA 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 Vaccine Injury Act of 1986 (the NCVIA) mandates that certain

adverse events following the administration of vaccines specified in

the NCVIA be reported by physicians to the joint FDA/Centers for

Disease Control and Prevention Vaccine Adverse Event Reporting System.

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.

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 of 1994 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.

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 (Form FDA 3500A)

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 (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, 312 and

314 (drugs), and part 600 (biologics). Parts 310, 314, and 600 mandate

the use of the Form FDA 3500A for reporting to FDA on adverse events

that occur with drugs and biologics; under Sec. 312.32, written IND

safety report notifications may be submitted on Form FDA 3500A.

B. Medical Device Products

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

importers, or distributors of devices intended for human use to

establish and maintain records, make reports, and provide information

as the Secretary of Health and Human Services 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. These statutory requirements regarding mandatory reporting have

been codified by FDA under part 803. Part 803 mandates the use of Form

FDA 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.

The agency requested comments on proposed changes to the forms

which comprise this collection of information in the Federal Register

of November 10, 1998 (63 FR 63064). FDA received 21 comments from

interested parties.

Comments were made about the estimate of the ``hours per

response.'' One comment correctly stated that the ``estimate may be

about right for the physical act of filling out the form itself.''

Because Form FDA 3500A is used for mandatory reporting subject to

different regulations (i.e., Secs. 310.305, 312.32, 314.80, 600.80, and

803), this estimate for reporting burden is limited to completing the

form. Estimates of the burden placed on user-facilities, distributors,

and manufacturers to investigate a report and compile the necessary

information would be addressed in the final rules for those

regulations.

Comments on the mandatory version of the form generally addressed

the perceived major impact such a revision would have on the

pharmaceutical and medical device industry, particularly the financial

burden that would result from having to both reprogram their computer

systems to handle new data elements and produce printed copies of the

new form. Two major reasons for not revising the form at this time were

presented by multiple respondents as follows:

[[Page 50822]]

(1) The medical product industry (particularly the medical

device industry) is focused on ensuring Year 2000 compliance. To

dedicate computer personnel to totally revamp their computer systems

to handle the new form would not be possible at this time because of

the impact it would have on meeting absolute deadlines; and

(2) Given that the goal is for both the 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.

While the comments on the proposed revisions to the voluntary form

were mainly favorable, the agency has decided to not revise either form

at this time. This decision reflects both concern about the financial

burden that would be placed on FDA if the voluntary form 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.

Regarding voluntary reporting, updated instructions for completing

the Form FDA 3500 were posted on the Internet on the MedWatch home page

in December 1998, and are available by mail/fax upon request.

Questions/comments about adverse event/product problem reporting

received by the agency over time were used as a major focus for

revising the instructions. This updating included such changes as

incorporation of information designed to solicit information specific

to special nutritional products (e.g., dietary supplements) and current

Department of Health and Human Services names and definitions for race

to facilitate reporting of this aspect of the medical history.

In the same vein, an omnibus entitled ``Guidance on How to Complete

Form FDA 3500A'' for use by user facilities, distributors, importers,

and manufacturers for mandatory adverse event and product problem

reporting is being drafted. Also utilizing questions/comments about

adverse event/product problem reporting received by the agency over

time as a major focus for revision, the guidance will be designed to

minimize possible ambiguity and maximize the utility of Form FDA 3500A

as a tool for soliciting important safety-related information and data.

It is planned that this guidance will replace instructions that are

currently available.

As both the Forms FDA 3500 (instructions) and 3500A (guidance) 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

--------------------------------------------------------------------------------------------------------------------------------------------------------

Annual Frequency Total Annual Hours per

FDA Center(s)\1\ (21 CFR Section) No. of Respondents Per Response Responses Response Total Hours

--------------------------------------------------------------------------------------------------------------------------------------------------------

CBER/CDER

Form 3500\2\ 15,456 1 15,456 0.5 7,728

Form 3500A\3\ (310.305, 312.32, 314.80, 314.98, and 410 529.3 217,014 1 217,014

600.80)

CDRH

Form 3500\2\ 2,789 1 2,789 0.5 1,395

Form 3500A\3\ (part 803) 3,100 30.25 93,786 1 93,786

CFSAN

Form 3500\2\ 316 1 316 0.5 158

Form 3500A\3\ (No mandatory requirements) 0 0 0 1 0

Total Hours 320,081

Form 3500\2\ 9,281

Form 3500A\3\ 310,800

--------------------------------------------------------------------------------------------------------------------------------------------------------

\1\ 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).

\2\ Form FDA 3500 is for voluntary reporting.

\3\ Form FDA 3500A is for mandatory reporting.

Note.--The figures in Table 1 of this document are based on actual calendar year 1998 reporting experience. It is assumed that the number of reports

will remain stable.

The increase in reporting burden reflects a natural increase in the

number of reports coming into the agency. As more medical products are

approved by FDA and marketed, and as knowledge increases of the

importance of notifying FDA when adverse events and product problems

are observed, it can be expected that more reports will be submitted to

the agency either directly (voluntary Form FDA 3500) or via the

manufacturer/user-facility (mandatory Form FDA 3500A).

Dated: September 7, 1999.

William K. Hubbard,

Senior Associate Commissioner for Policy, Planning and Legislation.

[FR Doc. 99-24309 Filed 9-17-99; 8:45 am]

BILLING CODE 4160-01-F