[Federal Register: June 30, 2003 (Volume 68, Number 125)]
[Page 38711-38712]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003N-0273]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Research Study Complaint Form

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 and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on FDA's burden estimates to use an Internet-
based complaint form for public complaints concerning misconduct in 
research studies.

DATES: Submit written or electronic comments on the collection of 
information by August 29, 2003.

ADDRESSES: Submit electronic comments on the collection of information 
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 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 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

[[Page 38712]]

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: (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.
    Currently, FDA's Center for Drug Evaluation and Research, Division 
of Scientific Investigations (DSI), receives an average of about 150 
unsolicited complaints per year about scientific misconduct in clinical 
research through electronic mail, regular mail, telephone, and personal 
contacts. DSI will continue to receive and process such complaints. The 
internet-based complaint form for consumer complaints on research 
studies will provide an additional convenient and efficient way for the 
public to submit complaints regarding misconduct in clinical research. 
The complaint form asks questions about the individual, company, or 
organization that is the subject of the complaint; the event and the 
drug product(s) that prompted the complaint; and optional information 
about the person submitting the complaint. The complaint form is 
accessible at http://didit.devis.com/complaints. The username is 
``public'' and the password is ``fdapublic.''
    FDA will use the information collected through the complaint form 
to identify weaknesses in the current services provided to human 
subjects in clinical research and to improve and maintain a high 
quality of service to the affected public. The complaint form will be 
encrypted so that any information of a sensitive nature will not be 
unnecessarily or prematurely disclosed. The complainants will remain 
anonymous unless they voluntarily disclose their identity. 
Participation is fully voluntary and complainants will be able to 
complete, review, edit, and submit the form to FDA. DSI will 
acknowledge the receipt of each complaint.
    DSI will complete initial analyses of the information from each 
complaint within 10 working days. Each complaint will be reviewed by a 
responsible person in DSI and then distributed to the appropriate unit 
in DSI or FDA for further action. DSI will contact the complainant if 
the complainant requests a followup contact. If the complainant does 
not request any followup contact, then no additional contact with the 
complainant is anticipated.
    FDA estimates that approximately 144 persons will voluntarily 
complete the complaint form each year. The estimated time for 
completing each complaint form will be 1 hour, resulting in a total 
burden of 144 hours per year (144 complainants x 1 hour = 144 burden 
hours per year). The burden of this collection of information is 
estimated as follows:

                                 Table 1.--Estimated One-Time Reporting Burden1
                          Annual Frequency per
   No. of Respondents           Response        Total Annual Records   Hours per Response        Total Hours
144                                1                   144                     1                   144
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

    Dated: June 24, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-16494 Filed 6-27-03; 8:45 am]