[Federal Register Volume 62, Number 249 (Tuesday, December 30, 1997)]
[Notices]
[Pages 67874-67876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33797]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 96N-0446]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

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 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 adverse drug experience 
reporting and recordkeeping requirements.

DATES: Submit written comments on the collection of information by 
March 2, 1998.

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.

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: 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

[[Page 67875]]

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.

Postmarketing Reporting of Adverse Drug Experiences--21 CFR 310.305 
and 314.80--(OMB Control Number 0910-0230--Reinstatement)

    Sections 201, 502, 505, and 701 of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 321, 352, 355, and 371) require that 
marketed drugs be safe and effective. In order to know whether drugs 
that are not safe and effective are on the market, FDA must be promptly 
informed of adverse experiences occasioned by the use of marketed 
drugs. In order to help ensure this, FDA issued regulations in 
Secs. 310.305 and 314.80 (21 CFR 310.305 and 314.80) to impose 
reporting and recordkeeping requirements on the drug industry that 
would enable FDA to take actions necessary for protection of the public 
health from adverse drug experiences.
    All applicants who have received marketing approval of drug 
products are required to report to FDA serious, unexpected adverse drug 
experiences, as well as followup reports when needed 
(Sec. 314.80(c)(1)). This includes reports of all foreign or domestic 
adverse experiences as well as those obtained in scientific literature 
and from postmarketing epidemiological/surveillance studies. Under 
Sec. 314.80(c)(2) applicants must provide periodic reports of adverse 
drug experiences. Under Sec. 314.80(i) applicants must keep for 10 
years records of all adverse drug experience reports known to the 
applicant.
    For marketed prescription drug products without approved new drug 
applications or abbreviated new drug applications, manufacturers, 
packers, and distributors are required to report to FDA serious, 
unexpected adverse drug experiences as well as followup reports when 
needed (Sec. 310.305(c)(1) and (c)(3)). Under Sec. 310.305(f) each 
manufacturer, packer, and distributor shall maintain for 10 years 
records of all adverse drug experiences required to be reported.
    The primary purpose of FDA's adverse drug experience reporting 
system is to provide a signal for potentially serious safety problems 
with marketed drugs. Although premarket testing discloses a general 
safety profile of a new drug's comparatively common adverse effects, 
the larger and more diverse patient populations exposed to the marketed 
drug provides, for the first time, the opportunity to collect 
information on rare, latent, and long-term effects. Signals are 
obtained from a variety of sources, including reports from patients, 
treating physicians, foreign regulatory agencies, and clinical 
investigators. Information derived from the adverse drug experience 
reporting system contributes directly to increased public health 
protection because the information enables FDA to make important 
changes to the product's labeling (such as adding a new warning) and, 
when necessary, to initiate removal of a drug from the market.
    Respondents to this collection of information are manufacturers, 
packers, distributors and applicants. FDA estimates the burden of this 
collection of information as follows:

                                  Table 1.--Estimated Annual Reporting Burden<SUP>1                                  
----------------------------------------------------------------------------------------------------------------
                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
----------------------------------------------------------------------------------------------------------------
310.305(c)(5)                           1               1               1               1               1       
314.80(c)(1)(iii)                       5               1               5               1               5       
314.80(c)(2)                          683               1.5         1,025               5           5,125       
Total                                                                                               5,131       
----------------------------------------------------------------------------------------------------------------
\1\ The reporting burden for Secs.  310.305(c)(1)(i), 310.305(c)(3), and 314.80(c)(1)(i) was reported in 0910-  
  0291. There are no capital costs or operating and maintenance costs associated with this collection of        
  information.                                                                                                  


                                 Table 2.--Estimated Annual Recordkeeping Burden<SUP>1                               
----------------------------------------------------------------------------------------------------------------
                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper                 
----------------------------------------------------------------------------------------------------------------
310.305(f)                             25               1              25               1              25       
314.80(i)                             683               1             683               1             683       
Total                                                                                               6,547       
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of            
  information.                                                                                                  


[[Page 67876]]

    These estimates are based on FDA's knowledge of adverse drug 
experience reporting, including knowledge about the time needed to 
prepare the reports and the number of reports submitted to the agency.

    Dated: December 18, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-33797 Filed 12-29-97; 8:45 am]
BILLING CODE 4160-01-F