Document ID: FDA-2008-N-0077-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; MedWatch: The Food and Drug Administration Medical Products Reporting Program
Posted Date: 2008-02-15T05:00Z

[Federal Register: February 15, 2008 (Volume 73, Number 32)]
[Notices]               
[Page 8879-8881]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15fe08-62]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0077]

 
Agency Information Collection Activities; Proposed Collection; 
Comment Request; MedWatch: The Food and Drug Administration Medical 
Products Reporting Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 the present MedWatch Forms 
3500 and 3500A (also known as MedWatch reporting forms) having an OMB 
expiration date of October 31, 2008. These forms are presently 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, dietary supplements, and non-prescription (over-the-counter 
(OTC)) human drug products marketed without an approved application.

DATES: Submit written or electronic comments on the collection of 
information by April 15, 2008.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. 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 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1482.

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.

MedWatch: The 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 (Public Law 103-417), 21 U.S.C. 342 is amended so that FDA must 
bear the burden of proof to show a dietary supplement is unsafe.

[[Page 8880]]

    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 310, 314, 
600, and 803), specifically Sec. Sec.  310.305, 314.80, 314.98, 600.80, 
803.30, 803.50, 803.53, and 803.56.
    Two forms are available from the agency in order 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, 
cosmetics, dietary supplements, and non-prescription (OTC) human drug 
products marketed without an approved application, as well as any other 
products that are regulated by FDA. Form FDA 3500 may be used by health 
care professionals and the public for voluntary (i.e., not mandated by 
law or regulation) reporting. Form FDA 3500A is used by industry for 
mandatory reporting (i.e., required by law or regulation).
    Respondents to this collection of information are health care 
professionals, hospitals and other user-facilities (e.g., nursing 
homes, etc.), consumers, manufacturers of biological and drug products 
or medical devices, and importers.

I. 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 (Public Law 99-660). Those 
mandatory reports are not submitted to FDA on the 3500 or 3500A forms, 
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.hhs.gov/pdf/vaers_form.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 device-related deaths and 
serious injuries.

II. Use of Form FDA 3500A (Mandatory Version)

A. Drug and Biologic Products

    In sections 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 600 (biologics). Parts 310, 314, and 600 mandate the use of 
FDA Form 3500A for reporting to FDA on adverse events that occur with 
drugs and biologics.
    Manufacturers whose name (under section 403(e)(1) of the act (21 
U.S.C. 343(e)(1)) appears on the label of a dietary supplement marketed 
in the United States are required to report adverse reactions 
associated with use of the dietary supplement to FDA (the Dietary 
Supplement and Nonprescription Drug Consumer Protection Act (Public Law 
109-462)).

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 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 their safety and effectiveness. The Safe Medical 
Device Act of 1990 (Public Law 91-4243), 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.''
    Under section 303 of the FDA Amendments Act of 2007 (Public Law 
110-85), FDA must share reports for Humanitarian Device Exemption (HDE) 
devices. To facilitate sharing the appropriate reports, it would be 
helpful to obtain the HDE number in the present section G, box 5, on 
page 2 of FDA Form 3500A.

III. Proposed Modifications to Forms

    The proposed extension to Form FDA 3500 and Form FDA 3500A will 
only have changes in the form instructions to reflect the range of 
reportable products and provide clarity of reporting. The previous 
forms changes (2005-2008) allow reporters to better utilize available 
space for data entry and offer voluntary reporters the opportunity to 
clearly describe the suspected adverse event, product problem or error, 
and provide better quality safety-related data for agency evaluation.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                            No. of       Annual Frequency  per     Total Annual         Hours per
                     FDA Center                          Respondents            Response            Responses           Response          Total Hours
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CBER/CDER
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  Form 3500                                                      22,955                    1               22,955                 0.6             13,773

[[Page 8881]]

  Form 3500A (Sec.  Sec.   310.305, 314.80, 314.98,                 600                  579.9            347,940                 1.1            382,734
   and 600.80)
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CDRH
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  Form 3500                                                       3,433                    1                3,433                 0.6              2,060
  Form 3500A (Part 803)                                           1,935                   33               63,855                 1.0             63,855
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CFSAN
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  Form 3500                                                         847                    1                  847                 0.6                508
  Form 3500A                                                          0                    0                    0                 1.0                  0
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Form 3500                                                                                                                                         16,341
Form 3500A                                                                                                                                       446,589
Total                                                                                                                                            462,930
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\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). FDA Form 3500 is for voluntary reporting; FDA Form 3500A is for mandatory
  reporting.

    Please note that on January 15, 2008, the FDA Web site transitioned 
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will 
be accepted by FDA through FDMS only.

    Dated: February 8, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-2821 Filed 2-14-08; 8:45 am]

BILLING CODE 4160-01-S