[Federal Register Volume 63, Number 106 (Wednesday, June 3, 1998)]
[Notices]
[Pages 30239-30241]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-14721]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 96N-0393]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 July 
6, 1998.
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: 
Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Mark L. Pincus, Office of Information 
Resources Management (HFA-80), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1471.

SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the

[[Page 30240]]

PRA (44 U.S.C. 3507), FDA has submitted the following proposed 
collection of information to OMB for review and clearance:

MedWatch: FDA's Medical Product Reporting Program, Forms FDA 3500 
and FDA 3500A (OMB Control Number 0910-0291--Reinstatement)

    Under sections 505, 507, 512, 513, 515, and 903 of the Federal 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355, 357, 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)(2) of the act, a 
drug or device is misbranded if it fails to bear adequate warnings, and 
under section 502(j), a drug or device is misbranded if it is dangerous 
to health when used as directed in its labeling. To carry out its 
responsibilities under these statutory provisions, 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 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. FDA has 
issued regulations requiring reporting of adverse events and product 
problems for human drugs, biologics, and devices in 21 CFR 310.305, 
314.80, 600.80, 803.30, 803.50, 805.53, and 803.56. These regulations 
implement statutory adverse event reporting requirements in sections 
505(k) and 512(l) of the act and section 2125 of the Public Health 
Service Act (42 U.S.C. 300aa-25).
    To carry out these provisions for mandatory reporting of adverse 
events and product problems with human drugs, biologics, and devices, 
and to facilitate voluntary reporting for certain other products that 
FDA regulates, two very similar forms are used. These forms replaced 
other forms previously used by the agency, including Form FDA 1639. 
Form FDA 3500A is used for mandatory reporting. 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.
    Respondents to this collection of information are health 
professionals; hospitals and other health care providers (i.e., nursing 
homes, etc.); manufacturers of biologics, drugs, and medical devices; 
user facilities; distributors; and importers.
    In a notice published in the Federal Register of December 18, 1996 
(61 FR 66673), FDA invited comments on Forms FDA 3500 and FDA 3500A 
(hereinafter referred to as the December 18, 1996, notice).
    FDA received two comments in response to the December 18, 1996, 
notice, one from industry and one from a trade association. Both 
comments generally supported the reinstatement of Form FDA 3500A and 
opposed any major changes to the structure of the form, since many 
manufacturers have made investments in systems that produce computer 
facsimiles of the form. However, both comments questioned the need for 
Form FDA 3417, the medical device ``Baseline Report,'' saying that 
virtually all of the information is or could be provided to FDA on 
either the 3500A form or through the medical device registration and 
listing process.
    FDA agrees that there is a redundancy of certain data elements 
between the MedWatch Form FDA 3500A, the medical device baseline 
report, and the medical device registration and listing forms. The 
Center for Devices and Radiological Health (CDRH) plans to evaluate 
data collected under the current medical device reporting (MDR) program 
over the next 6 months. CDRH will then attempt to redesign the forms 
related to medical device reporting, including parts of Form FDA 3500A. 
The redesign will be presented in an interactive fashion to industry 
and OMB in late 1998. The redesigned forms will be made available for 
public comment in early 2001 and will be instituted in late 2001, 
assuming that OMB approval has been obtained.
    Both comments disagreed with FDA's estimate of the hours per 
response for medical device reports submitted on Form FDA 3500A. One of 
the comments correctly stated that the estimate of one hour per 
response ``may be about right for the physical act of filling out the 
form itself,'' but felt it was ``a gross underestimate of the time 
necessary to `respond''' due to the number of hours it takes to gather 
the information required by the form. The comment suggested that FDA's 
original estimate of 1 hour per response be changed to a range of 1 to 
5 hours, depending on the complexity of the event. FDA agrees with the 
comment's statement that the agency's estimate accurately reflects the 
time necessary to fill out the form; however, the agency disagrees that 
the estimate for Form 3500A should be modified to cover the time 
necessary to gather the required information, as this burden has 
already been counted under the medical device reporting regulations. 
The burden placed on medical device user facilities, importers, 
distributors, and manufacturers to investigate a report and compile the 
necessary information to complete Form FDA 3500A was included in a 
separate burden estimate that was subjected to public comment (see 60 
FR 63578 at 63597) and approved by OMB (OMB control number 0910-0059). 
Accordingly, to avoid duplication, FDA's estimate for Form 3500A has 
been intentionally limited to the time needed for the actual completing 
of the form.
    This comment also stated that FDA's estimate did not account for 
the burden of filing a supplemental MedWatch report on Form FDA 3500A 
when more information is obtained after the filing of the original 
report. FDA disagrees with the comment's second criticism, however. 
Supplemental MedWatch reports are also filed on Form FDA 3500A. 
Although such supplemental reports are not listed separately in the 
burden chart, they are included as part of the estimated total number 
of Form FDA 3500A submissions for each agency component.
    The other comment argued that FDA's estimate was too low because it 
did not include the burden of preparing and submitting medical device 
baseline reports on Form FDA 3417. FDA disagrees with this comment. The 
medical device baseline report is not part of the MedWatch collection 
of information (OMB control number 0910-0291) for which FDA is 
requesting reinstatement. Rather, the medical device baseline report is 
a separate collection of information that has already undergone public 
comment (see 60 FR 63578 at 63597) and received OMB approval (OMB 
control number 0910-0059). As noted above, however, FDA does plan to 
revise the medical device baseline report form and other medical device 
reporting forms to eliminate duplication, and the agency will seek 
public comment on the revisions.
    FDA estimates the burden of this collection of information as 
follows:

Table 1.--Estimated Annual Reporting Burden\1\

[[Page 30241]]



                                                                                                                
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                                                  Annual                                                        
            Form                  No. of       Frequency per   Total Annual      Hours per        Total Hours   
                                Respondents      Response        Responses       Response                       
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CBER:                                                                                                           
    Form FDA 3500                 804               1             804               0.5               402       
    Form FDA 3500A                 63             158.5         9,988               1.0             9,988       
                                                                                                                
CDER:                                                                                                           
    Form FDA 3500              14,875               1          14,875               0.5             7,438       
    Form FDA 3500A                500             375         187,522               1.0           187,522       
                                                                                                                
CDRH:                                                                                                           
    Form FDA 3500               2,807               1           2,807               0.5             1,404       
    Form FDA 3500A             39,889               2.05       81,928               1.0            81,928       
                                                                                                                
CFSAN:                                                                                                          
    Form FDA 3500                 646               1             646               0.5               323       
    Form FDA 3500A                  0               0               0               1.0                 0       
                                                                                                                
Total Hours                                                                                       289,005       
                                                                                             -------------------
    Form FDA 3500                                                                                   9,567       
    Form FDA 3500A                                                                                279,438       
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of            
  information.                                                                                                  
Note: CBER = Center for Biologics Evaluation and Research; CDER = Center for Drug Evaluation and Research; CDRH 
  = Center for Devices and Radiological Health; CFSAN = Center for Food Safety and Applied Nutrition. Form FDA  
  3500 is for voluntary reporting; Form FDA 3500A is for mandatory reporting.                                   

    As more medical products are approved by FDA and marketed, FDA 
expects that more reports will be submitted. The figures in the table 
are based on the average number of reports received in FY 1996, 
adjusted for the anticipated annual increase in reports. The 
anticipated annual increase
in reports is based on the average annual increase from 1993 to 1996. 
There are zeroes in the CFSAN row for Form FDA 3500A because mandatory 
reporting using Form FDA 3500A is not applicable to foods.

    Dated: May 28, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-14721 Filed 6-2-98; 8:45 am]
BILLING CODE 4160-01-F