[Federal Register Volume 61, Number 244 (Wednesday, December 18, 1996)]
[Notices]
[Pages 66673-66675]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32070]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0393]


Agency Information Collection Activities: Proposed Collection; 
Comment Request; Reinstatement

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, 
Federal agencies are required to publish notice in the Federal Register 
concerning each proposed collection of information, including each 
proposed reinstatement of an existing collection of information, and to 
allow 60 days for public comment in response to the notice. This notice 
solicits comments on MEDWATCH medical product reporting program forms, 
FDA form 3500 and 3500A.

DATES: Submit written comments on the collection of information by 
February 18, 1997.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.


[[Page 66674]]


FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, rm. 16B-19, Rockville, MD 20857, 301-827-1472.

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 reinstatement 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 listed below.
     With respect to the following collection of information, FDA 
invites comments on: (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--FDA's Medical Products Reporting Program, Forms FDA 3500 and 
FDA 3500A--21 CFR 310.305, 314.80, 600.80, 803.30, 803.50, 803.53, 
803.56 (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(f)(2)), 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. 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 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 21 CFR 310.305, 314.80, 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. These forms replaced all other forms 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.
    FDA estimates the burden of this collection of information as 
follows:

                                        Estimated Annual Reporting Burden                                       
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                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
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CBER:                                                                                                           
  600.80                                                                                                        
  Form 3500                           993               1             993               0.5           496.5     
  Form 3500A                           63             188.7        11,889               1.0        11,889       
                                                                                                                
CDER:                                                                                                           
  310.305 and 314.80                                                                                            
  Form 3500                        19,922               1          19,922               0.5         9,961       
  Form 3500A                          500             303.0       151,513               1.0       151,513       
                                                                                                                
CDRH:                                                                                                           
  803.30, 803.50, 803.53, and                                                                                   
 803.56                                                                                                         
  Form 3500                         4,572               1           4,572               0.5         2,286       
  Form 3500A                       39,889               2.8       110,933               1.0       110,933       
                                                                                                                
CFSAN:                                                                                                          
  Form 3500                           410               1             410               0.5           205       
  Form 3500A                            0               0               0               0               0       
Total Hours                                                                                       287,283.5     
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There are no capital costs or operating and maintenance costs associated with this collection.                  

(Note: Center for Biologics Evaluation and Research (CBER); Center for 
Drug Evaluation and Research (CDER); Center for Devices and 
Radiological Health (CDRH); and Center for Food Safety and Applied 
Nutrition (CFSAN).
    As more medical products are approved by FDA and marketed, and as 
knowledge increases regarding the

[[Page 66675]]

importance of notifying FDA when adverse events and product problems 
are observed, it is expected that more reports will be submitted. The 
figures shown in the table are based on previously calculated estimates 
and actual 1995 reporting experiences. The number of reports recorded 
above were annualized based on actual 1995 experience and an 
anticipated 10-percent-per-year increase in reporting over the next 3 
years. There are zeroes in the CFSAN row because mandatory reporting 
using Form FDA 3500A is not required.

    Dated: December 11, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-32070 Filed 12-17-96; 8:45 am]
BILLING CODE 4160-01-F