[Federal Register: May 3, 2005 (Volume 70, Number 84)]
[Notices]               
[Page 22882-22884]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03my05-61]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0157]

 
Agency Information Collection Activities; Proposed Collection; 
Comment Request; Postmarketing Adverse Drug Experience Reporting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 postmarketing adverse drug 
experience reporting and recordkeeping requirements.

DATES: Submit written or electronic comments on the collection of 
information by July 5, 2005.

ADDRESSES: Submit electronic comments on the collection of information 
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. 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: Karen L. Nelson, Office of Management 
Programs (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 requirement 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

[[Page 22883]]

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.

Postmarketing Adverse Drug Experience Reporting--21 CFR 310.305 and 
314.80 (OMB Control Number 09109-0230)--Extension

    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 at 
Sec. Sec.  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 action 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. A periodic report includes, for the reporting interval, 
reports of serious, expected adverse drug experiences and all 
nonserious adverse drug experiences, a narrative summary and analysis 
of adverse drug experiences and a history of actions taken because 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)). 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\1\
----------------------------------------------------------------------------------------------------------------
                                         Annual Frequency per    Total Annual      Hours Per
 21 CFR Section    No. of Respondents          Response           Responses         Response       Total Hours
----------------------------------------------------------------------------------------------------------------
310.305(c)(5)                       1                      1                1                1                1
314.80(c)(1)(ii                     5                      1                5                1                5
 i)
314.80(c)(2)                      530                     20           10,614               28          297,192
Total            .....................  .....................  ...............  ...............         297,198
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                     Annual Frequency per
               21 CFR Section                 No. of Recordkeepers      Recordkeeping       Total Annual Records     Hours per Record      Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
310.305(f)                                                     25                      1                     25                      1               25
314.80(i)                                                     530                      1                    530                      1              530
Total                                        .....................  .....................  .....................  .....................             555
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 22884]]

    These estimates are based on FDA's knowledge of adverse drug 
experience reporting, including the time needed to prepare the reports, 
and the number of reports submitted to the agency during 2004.

    Dated: April 26, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-8737 Filed 5-2-05; 8:45 am]

BILLING CODE 4160-01-S