[Federal Register Volume 68, Number 82 (Tuesday, April 29, 2003)]
[Notices]
[Pages 22716-22719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-10616]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03N-0016]


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.

[[Page 22717]]


DATES: Fax written comments on the information collection provisions by 
May 29, 2003.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that written comments be 
electronically mailed to [email protected] or faxed to the Office of 
Information and Regulatory Affairs, OMB, Attn: Stuart Shapiro, Desk 
Officer for FDA, FAX 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1482.

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 (OMB Control 
Number 0910-0291)--Extension

    Under sections 512, 513, 515, and 903 of the Federal Food, Drug, 
and Cosmetic Act (the act) (21 U.S.C. 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. A drug or device is misbranded under section 502(f)(1) of 
the act if its labeling does not bear adequate warnings for use, and 
under section 502(j) of the act 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 medication error 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 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, and 803 (21 CFR 
parts 310, 314, 600, and 803), specifically Sec. Sec.  310.305, 314.80, 
314.98, 600.80, 803.30, 803.40, 803.50, 803.53, 803.56.
    To implement these provisions for reporting of adverse events, 
product problems and/or medication error with medications, devices, 
biologics, and special nutritional products, 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, product problems and 
medication errors 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, and manufacturers, packers, distributors, and 
importers of biological and drug products and medical devices.

II. Use of the Voluntary Version (FDA Form 3500)

    The voluntary version of the form is used to submit all adverse 
event, product problems, and medication error reports not mandated by 
Federal law or regulation.
    Individual health professionals are not required by law or 
regulation to submit adverse event, product problem, or medication 
error 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 submitted by physicians 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/vaers 
for pdf version), rather than the FDA 3500 or 3500A forms.
    Hospitals are not required by Federal law or regulation to submit 
adverse event reports, product problems, or medication errors 
associated with medications, biological products, or special 
nutritional products. However, hospitals and other user facilities are 
required by Federal law to report medical device related deaths and 
serious illnesses or 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 puts the onus on FDA to prove that a particular product is 
unsafe. The agency is dependent on the voluntary reporting by health 
professionals and consumers of suspected adverse events associated with 
the use of dietary supplements.

III. Use of the Mandatory Version (FDA Form 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 and 314 
(drugs) and 600 (biologics). Parts 310, 314, and 600 mandate the use of 
the FDA Form 3500A form for reporting to FDA on adverse events that 
occur with drugs and biologics.
    (Note: Most pharmaceutical manufacturers already use a 1-page 
modified version of the 3500A form where section G from the back of the 
form is substituted for section D on the front of the form.)

B. Medical Device Products

    Section 519 of the act (21 U.S.C. 360i) requires manufacturers, 
packers and distributors and 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 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 amended section 519 
of the act to require 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 requires the use of the 
FDA Form 3500A for mandatory reporting to FDA on medical devices.
    The Food and Drug Administration Modernization Act of 1997 
eliminated the reporting requirements for domestic

[[Page 22718]]

distributors of medical devices. In addition, section 303 of the 
Medical Device User Fee and Modernization Act of 2002 directs FDA to 
modify the MedWatch mandatory and voluntary forms to facilitate the 
reporting of information by user facilities or distributors as 
appropriate relating to reprocessed single-use devices, including the 
name of the reprocessor and whether the device has been reused.

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.
    FDA estimates the burden for completing the forms for this 
collection of information as follows:

                                   Table 1.--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
 FDA Center/(21        No. of        Annual Frequency      Total Annual         Hours per
  CFR Section)      Respondents        per Response         Responses           Response          Total Hours
----------------------------------------------------------------------------------------------------------------
CBER/CDER
----------------------------------------------------------------------------------------------------------------
  Form 3500                 20,074               1                 20,074               0.5               10,037
----------------------------------------------------------------------------------------------------------------
  Form 3500A                   600             463.86             278,315               1.0              278,315
   (Sec.  Sec.
     310.305,
   314.80,
   314.98, and
   600.80)
----------------------------------------------------------------------------------------------------------------
CDRH
----------------------------------------------------------------------------------------------------------------
  Form 3500                  3,252               1                  3,252               0.5                1,626
----------------------------------------------------------------------------------------------------------------
  Form 3500A                 1,935              33                 63,623               1.0               63,623
   (part 803)
----------------------------------------------------------------------------------------------------------------
  Sec.   803.10              2,845               2.4                6,828                .17               1.160
----------------------------------------------------------------------------------------------------------------
CFSAN
----------------------------------------------------------------------------------------------------------------
  Form 3500                    895               1                    895               0.5                  448
----------------------------------------------------------------------------------------------------------------
  Form 3500A                     0               0                      0               1.0                    0
   (no
   mandatory
   requirements
   )
================================================================================================================
Total Hours                                                                                              355,209
----------------------------------------------------------------------------------------------
  Form 3500                                                                                               13,271
----------------------------------------------------------------------------------------------
  Form 3500A                                                                                             343,098
----------------------------------------------------------------------------------------------------------------
(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 
calendar year 2002 reports and respondents for each center and type of 
report.

                               Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
 FDA Center/21         No. of        Annual Frequency      Total Annual         Hours per
  CFR Section      Recordkeepers     per Recordkeeping       Records          Recordkeeper        Total Hours
----------------------------------------------------------------------------------------------------------------
CDRH
----------------------------------------------------------------------------------------------------------------
  803.10                     2,845               2.4                6,828                .17               1,160
----------------------------------------------------------------------------------------------------------------
Total                                                                                                      1,160
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    In the Federal Register of February 10, 2003 (68 FR 6752), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. Two comments from organizations (Health Industry 
Manufacturers Association and Baxter Healthcare Corp.) were submitted. 
In general, the comments supported the reinstatement of the 3500A form 
with little or no modification since most manufacturers had made 
investments in systems that produce computer facsimiles of the form. 
Both organizations also questioned the need for a medical device 
``Baseline Report,'' saying that most of the information is already 
provided to FDA on either the 3500A form or through the Medical Device 
registration and listing process.
    FDA recognized the impact that a major modification of the 3500A 
form would have on computerized systems in place across the 
pharmaceutical and medical device industry. In addition, the agency 
agreed that there is redundancy of certain data elements among the 
3500A, Baseline Report and the Medical Device Registration and Listing 
Process. However, the agency also felt that certain elements found on 
the baseline form and not duplicated elsewhere were essential. At that 
time,

[[Page 22719]]

experience with the use of the 3500A for mandatory medical device 
reporting and the need to collect information found only on the 
baseline report led the agency in 1998 to propose a major modification 
to the medical device sections of the 3500A form.

    Dated: April 24, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-10616 Filed 4-25-03; 11:16 am]
BILLING CODE 4160-01-S