Notice: Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; MedWatch: Food and 
Drug Administration Medical Products Reporting Program

Federal Register: September 24, 2008 (Volume 73, Number 186)               
                  Page 55111-55114

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information 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: Fax written comments on the collection of information by October 
24, 2008.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-6974, or e-mailed to baguilar@omb.eop.gov. All comments 
should be identified with the OMB control number 0910-0291.

[[Page 55112]]


FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3792.

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: Food and Drug Administration Medical Products Reporting 
Program (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, 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 21 CFR parts 310, 314, 600, 803, and 1271, 
specifically Sec. Sec.  310.305, 314.80, 314.98, 600.80, 803.30, 
803.50, 803.53, 803.56, and 1271.350(a).
    Two forms are available from the agency 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, including human tissue, cell, tissue 
and cellular-based products, special nutritional products, and 
cosmetics, as well as any other products that are regulated by FDA. 
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 user facilities (e.g., nursing 
homes, etc.), consumers, manufacturers of biological, drug, and dietary 
supplement 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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. 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) (21 U.S.C. 355(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), 600 (biologics) and 1271 (Human 
Cells, Tissues, and Cellular and Tissue-Based Products). 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. The Dietary 
Supplement and Nonprescription Drug Consumer Protection Act (Public Law 
109-462, 120 Stat. 3469) amended the act with respect to adverse event 
reporting and recordkeeping for dietary supplements and non-
prescription drugs marketed without an approved application. The law 
provides for the mandatory reporting to FDA of serious adverse events 
for over-the-counter (OTC) drug products. The authority is 21 U.S.C. 
379aa-1(a)(3), (b)(1) and/or section 761(a)(3) and (b)(1) of the act.

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 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.

C. Dietary Supplements

    The Dietary Supplement and Nonprescription Drug Consumer Protection 
Act amended the act with respect to adverse event reporting and

[[Page 55113]]

recordkeeping for dietary supplements and non-prescription drugs 
marketed without an approved application. The law provides for the 
mandatory reporting to the Food and Drug Administration of serious 
adverse events for dietary supplements. The authority is 21 U.S.C. 
379aa-1(a)(3), (b)(1) and/or section 761(a)(3) and (b)(1) of the act.

IV. Proposed Modifications to Forms

    FDA has proposed no modification to either the Form FDA 3500 or 
Form FDA 3500A at this time. The requested extension for both forms 
will only result in changes in the form instructions rather than in any 
content or formatting for either form. The ability to change the 
instructions will allow for any and all necessary clarifications in the 
use of the form and can reflect the current range of reportable 
products (e.g., OTC products and dietary supplements).
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                        No. of         Annual Frequency      Total Annual        Hours per
   FDA Center        Respondents         per Response         Responses          Response         Total Hours
----------------------------------------------------------------------------------------------------------------
CBER/CDER
----------------------------------------------------------------------------------------------------------------
  Form 3500                  23,033                    1             23,033               0.6             13,820
  Form 3500A                    600                  765            459,102               1.1            505,012
   (Sec.  Sec.
   310.305,
   314.80,
   314.98, and
   600.80)
----------------------------------------------------------------------------------------------------------------
CDRH
----------------------------------------------------------------------------------------------------------------
  Form 3500                   4,375                    1              4,375               0.6              2,625
  Form 3500A      .................  ...................  .................  ................  .................
   (Part 803)
  User                        1,084                    3              3,252               1.1              3,577
  Facilities                     80                   18              1,470               1.1              1,617
  Importers                   2,946                   48            141,405               1.1            155,545
  Manufacturers   .................  ...................  .................  ................            160,739
  Total 3500A     .................  ...................  .................  ................            163,364
  Total CDRH      .................  ...................  .................  ................  .................
----------------------------------------------------------------------------------------------------------------
CFSAN
----------------------------------------------------------------------------------------------------------------
  Form 3500                     479                    1                479               0.6                287
  Form 3500A                      0                    0                  0               1.1                  0
----------------------------------------------------------------------------------------------------------------
Form 3500                                                                                                 16,732
Form 3500A                                                                                               665,751
Total                                                                                                    682,483
----------------------------------------------------------------------------------------------------------------
\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). Form
  FDA 3500 is for voluntary reporting. Form FDA 3500A is for mandatory reporting. There are no capital costs or
  operating and maintenance costs associated with this collection of information. (NOTE--The figures shown in
  table 1 of this document are based on actual calendar year 2007 reports and respondents. There is no burden
  calculation for the mandatory reporting requirements which went into effect on December 22, 2007, for dietary
  supplements (CFSAN) or OTC drugs (CDER). These estimates and opportunities for public comment will be
  addressed separately by FDA and will also be incorporated in subsequent requests for extension of Forms FDA
  3500 and 3500A.)

    In the Federal Register of February 15, 2008 (73 FR 8879), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. FDA received three comments. There were no 
comments submitted concerning the Form FDA 3500, voluntary reporting 
form. All comments addressed Form FDA 3500A, the mandatory reporting 
form. There were no comments submitted concerning the mandatory 3500A 
form that addressed questions of whether the information obtained is 
necessary for the proper performance of FDA's functions or comments 
about the practical utility of this information. There was one comment 
about the accuracy of the burden estimate for a subset of reports 
(dietary supplements). The remainder of the comments were specific 
suggestions for modifications of either the content or format of 
various fields to enhance clarity of information. There was also one 
comment about the use of information technology to support collection.
    One comment noted that there was no burden estimate offered for the 
mandatory reports that would be expected for serious adverse events 
associated with dietary supplement products. In addition, the comment 
offered an estimate of 30 minutes to 1 hour for the time to complete, 
route for approval, and submit a mandatory report for a dietary 
supplement product. FDA agrees with this estimate and, for mandatory 
reports, has used a 1.1 hour estimate for time to complete a report. 
FDA has chosen to not attempt to estimate a reporting burden for 
mandatory dietary supplement report volume, because the burden estimate 
used in this request for extension of both reporting forms is based on 
actual reports for the calendar year 2007 and there was no requirement 
for submission of mandatory dietary supplement reports until December 
22, 2007. To address PRA burden estimates for mandatory reporting 
required for both dietary supplements and OTC products under the 
Dietary Supplement and Nonprescription Drug Consumer Protection Act of 
2006, FDA will submit this burden estimate information under a separate 
Federal Register notice process.
    There were several comments suggesting a variety of changes in the 
formatting of certain fields in the mandatory form, changes to existing 
text, or addition of extra text. These changes were suggested to 
``reduce confusion and capture additional clarifying information.'' For 
example, it was suggested that more space be allotted to certain fields 
to accept more

[[Page 55114]]

text or that certain text fields be modified to ask supplemental 
questions of the reporter.
    FDA has carefully considered each of these changes but does not 
concur with making these elective changes, which are not based on any 
changes in law, rule, or regulation. Because FDA encourages electronic 
submission of postmarketing adverse event reports by mandatory 
reporters, and the majority of mandatory reporters use the paper-based 
Form FDA 3500A only for backup purposes, the agency believes that it 
would be an unfair burden to manufacturers who submit electronically to 
expend resources to change their electronic versions of the paper 
document which would be used only in times of rare network or server 
outages. FDA believes that each of these suggested elective text 
changes and additions can be addressed satisfactorily with specific 
clarifying information provided in the instructions section that 
supplements Form FDA 3500A.
    One comment suggests that FDA modify the forms to include wording 
as a ``disclaimer by consumer authorizing the treating physician to 
speak with a manufacturer's representative.'' FDA disagrees with the 
inclusion of this type of information within the standard reporting 
form and believes that this type of information is best treated as part 
of other documentation maintained by the mandatory reporter.
    One comment suggests that provisions be made to allow for the 
inclusion of attachments with the serious adverse event report. FDA 
agrees and attachments are currently permitted both as supplements to 
mailed and faxed submissions. One comment acknowledged and supported 
the recently announced development of a unified federal approach to 
adverse event reporting, and suggested that this approach will ease the 
reporting burden for both industry and FDA and indirectly benefit 
consumers.
    The newly revised Forms FDA 3500 and 3500A with updated 
instructions, which will address several comments' concerns about 
clarity, will be made available, upon OMB approval, on the FDA's 
MedWatch Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/medwatch/getforms.htm. 

    Dated: September 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-22440 Filed 9-23-08; 8:45 am]

BILLING CODE 4160-01-S