[Federal Register Volume 70, Number 241 (Friday, December 16, 2005)]
[Notices]
[Pages 74817-74822]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-24102]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0273]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Research Study 
Complaint Form

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by January 
17, 2006.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being

[[Page 74818]]

accepted. To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk 
Officer for FDA, FAX: 202-395-6974.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Research Study Complaint Form

    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 regulated by FDA through electronic mail, regular mail, phone, 
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 regulated by FDA. 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 will be accessible at http://didit.devis.com/complaints (username: public; password: fdapublic).
    FDA will use the information collected through the complaint form 
to identify inadequacies in the current services and practices 
involving human subjects in clinical research and to improve and 
maintain high quality of services and practices for 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 complaints will remain anonymous unless the complainant voluntarily 
discloses their identity. Participation is fully voluntary, and 
complainants will be able to complete, review, edit, and submit the 
form directly to the FDA. DSI will acknowledge the receipt of each 
complaint.
    Initial analyses by DSI of the information from each complaint will 
be completed 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 one 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 Burden\1\
----------------------------------------------------------------------------------------------------------------
     Number of        Annual Frequency Per
    Respondents             Response          Total Annual Responses   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
  information.

    In the Federal Register of June 30, 2003 (68 FR 38711), FDA 
requested comments on this information collection. FDA received 3 
comments.
    (Comment 1) One comment stated that the collection of information 
is not necessary for the proper performance of FDA's functions. The 
comment noted that FDA states that it currently receives 150 complaints 
per year related to alleged scientific misconduct in clinical research 
via e-mail, mail, and personal contacts, and will continue to accept 
complaints via these routes. The comment stated that the current system 
by which FDA accepts complaints spontaneously appears effective and 
that an additional route is not needed. The comment discouraged the use 
of an Internet form through which very few complaints may be expected 
to be filed. The comment stated that it is neither clear that an 
Internet collection would offer any advantage over existing routes, nor 
is it clear that it will facilitate the filing of complaints.
    (Response) FDA initiates investigations to detect fraud and 
noncompliance in clinical research based on the complaints it receives. 
These investigations help FDA to assure that clinical research data 
submitted to the agency is truthful and accurate and, thereby, help FDA 
to protect the public by assuring the safety and efficacy of human 
drugs and biological products. Although the current system of receiving 
complaints via e-mail, mail, and personal contact, are effective, FDA 
is constantly attempting to improve its effectiveness by using 
innovative ideas and processes. Ease of access to an Internet-based 
complaint form, ability to submit complaints anonymously, and the 
ability to provide responses to pertinent and standard questions listed 
on the complaint form offer advantages over the current processes of 
collecting complaints. It is not possible to predict how many 
complaints will be submitted to FDA using the Internet-based complaint 
form. Once the Internet-based complaint form becomes available to the 
public and the public finds the form easy to use, FDA hopes that the 
form will become a much more standard means for the public to submit 
complaints that pertain to FDA-regulated research. The increased use of 
the Internet-based form will also relieve FDA staff from the time-
consuming process of personally documenting each complaint.
    The comment also noted that FDA estimates it will take respondents 
1 hour to complete the form. The comment stated that while this 
estimate is reasonable, it may take longer for respondents to locate 
the form on the Internet. The comment stated that it is not obvious on 
which Web site(s) the form will appear (e.g., National Institutes of 
Health (NIH) clinical trial sites, HHS Web site (http://www.hhs.gov), 
FDA Web site(http://www.fda.gov)) and how easy it will be to locate.
    (Response) The public will be able to access the Internet-based 
complaint form on the home page of DSI's Web site. The DSI Web site is 
accessible to the public at http://www.fda.gov/cder/offices/dsi. This 
Web site will include a prominent and direct link to the Internet-based 
complaint form, which will provide easy access and use of the complaint 
form. The location of the

[[Page 74819]]

complaint form will also be publicized through presentations made by 
DSI staff at seminars and conferences.
    The comment stated that an ad hoc reporting of complaints offers a 
superior collection mechanism because it allows complaining parties to 
report alleged misconduct without steering the information offered by a 
form. The existing collections of information via phone, e-mail, fax, 
and mail are proven alternatives.
    (Response) The complaint form is not intended to direct the 
complainant's answer. The form may help the complainant to provide more 
pertinent information to the agency than he/she might otherwise 
provide. Each complainant will voluntarily submit the complaint. The 
complainant has the option of providing as much information as desired. 
There are only two questions on the complaint form that must be 
answered: (1) Who is the complaint about? and (2) What is the complaint 
about? If the complainant does not know the answer to any other 
question in the complaint form, or if the complainant does not wish to 
provide any additional information, the complainant may leave blank 
(unanswered) the space following each question. FDA notes that the 
existing methods of collecting complaint-related information often 
result in incomplete information and hence should not be assumed to be 
an existing proven alternative.
    The comment stated that if the Internet-based complaint form is 
used, it should be revised to improve the quality, utility, and clarity 
of the information to be collected as follows: The form should provide 
FDA with minimal information upon which to investigate a complaint. To 
this end, the form should be designed to facilitate its completion with 
readily available information. It may be unlikely that the reporter has 
the protocol number and full study title readily available.
    (Response) The complaint form has been revised to only obtain 
minimal information that would be sufficient to facilitate an FDA 
investigation. As mentioned previously in this document, there are only 
two questions on the complaint form that must be answered: (1) Who is 
the complaint about? and (2) What is the complaint about? If the 
complainant does not know the answer to any other question in the 
complaint form, or if the complainant does not wish to provide any 
additional information, the complainant may leave blank (unanswered) 
the space following each question. If the complainant is aware of 
study-specific information such as a protocol number and study title, 
they will have the option of providing such details in the complaint 
form. Hence, a complainant will have the option of only providing 
information that is readily available.
    The comment stated that the form should be accompanied by the 
following: (1) An introduction to the form, (2) an explanation as to 
how it is to be used, and (3) by instructions for its completion.
    (Response) The introduction to the complaint form has been revised 
to read as follows:

                           DSI Complaint Form
If you wish to report adverse events (adverse effects or adverse
 reactions) to drugs or report (medical) product problems, contact
 MedWatch.
If your complaint is about a research study, please complete this form.
The purpose of this form is for collecting information about the
 potential scientific or research misconduct, or questionable research
 practices, involving the use of an FDA regulated drug product.
You must answer the following two questions: (1) Who are you complaining
 about? and, (2) What is your complaint? If you do not know the answer
 to any other question in the complaint form, or if you do not wish to
 provide any additional information, you may leave a blank (unanswered)
 space following each question.
 


                     Who are you complaining about?
Please provide as much information as possible in this section. You must
 provide the name of a person, company, or organization about whom you
 are complaining. If you do not know the answer to any other question,
 or if you do not wish to provide any additional information, you may
 leave a blank (unanswered) space following each question.
Name of Person, Company, or Organization: (Required Information)
In addition, under the Complaint Information section, the following
 change will be made to the first question:
What is your complaint? (Required Information)
 

    The comment stated that the form could be improved by reordering 
the sections so that they appear in the following order: (1) Reporter 
Information, (2) Complaint Description, and (3) Organization About 
Which Complaint Refers.
    (Response) FDA has organized the sections based on the order of the 
importance of the information required for investigating a complaint. 
Hence, they appear in the following order: (1) The Organization That Is 
the Subject of the Complaint, (2) The Complaint Description, and (3) 
Reporter Information (which is optional).
    The comment stated that although the Federal Register notice states 
that FDA will contact the complainant if the complainant requests a 
followup contact, the form lacks this question.
    (Response) The optional reporter information section begins with 
the question ``May the FDA contact you for more information?'' If the 
answer is yes, the next question is ``How may we contact you? If by 
phone, please suggest times that are convenient for you.''
    The comment stated that the form should use terms and explanations 
easily understood by the public at no more than a sixth grade reading 
level. Terms like ``bioequivalence,'' ``sponsor,'' and ``monitor'' 
should be avoided as they are not widely known except by persons 
associated with pharmaceutical development.
    (Response) The complaint form was designed for the general public 
to understand. Terms like ``bioequivalence,'' ``sponsor,'' and 
``monitor'' will not be understood by everyone, but an individual who 
does not see a familiar radio-button to select can go to the field 
titled ``other'' and type the information as they know it.
    The comment stated that asking complaining parties to identify 
other study subjects does not seem consistent with the increased 
protections being afforded to the privacy of research subjects.
    (Response) Requesting complainants to identify other persons 
(subjects or staff) whom they already know, and who may be able to 
provide corroborating information pertaining to a complaint, is 
consistent with current practice. It is also important to note that the 
complainant is not always a study subject, and the names identified 
could include study personnel who were involved in the studies under 
complaint and who may be willing to provide information. In addition, 
it is important to note that FDA is able to review and copy the records 
of subjects in studies regulated by FDA. When there is sufficient 
reason to suspect the validity of data pertaining to specific subjects 
involved in research, FDA obtains the names of study subjects.
    After reviewing this section of the complaint form, FDA has revised 
the form to note that complainants should also be requested to provide 
any available contact information regarding those persons they identify 
as having the potential for providing additional complaint-related 
information. The complaint form question has been revised to read as 
follows: ``If you know the name(s) of other persons (subjects or

[[Page 74820]]

staff) who were involved in the study(ies), or anyone else who is 
willing to voluntarily provide information, please list them and 
include any available contact information (e.g. phone number, fax 
number, email address, mailing address, etc.).''
    Section 704(a) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 374(a)) and the Bioresearch Monitoring (BIMO) regulations at 21 
CFR 812.145(b), 21 CFR 312.68, and 21 CFR 56.115(b), permit FDA 
investigators at reasonable times to have access to, copy, and verify 
records. In addition, the subjects' informed consent forms are to 
include ``a statement describing the extent, if any, to which 
confidentiality of records identifying the subject will be maintained 
and that notes the possibility that the Food and Drug Administration 
may inspect the records'' (21 CFR 50.25(a)(5)). The disclosure of this 
information to FDA would be consistent with the Health Insurance 
Portability and Accountability Act of 1996 (HIPAA), and the Health and 
Human Service's (HHS') implementing regulation on Standards for Privacy 
of Individually Identifiable Health Information (the Privacy Rule). 
HIPAA and the Privacy Rule only apply to covered entities (i.e., health 
plans, health care clearinghouses, and to any health care provider who 
transmits health information in electronic form in connection with 
transactions for which the Secretary of HHS has adopted standards under 
HIPAA). As such, many complainants would not be covered by the Privacy 
Rule. Covered entities may use or disclose protected health information 
(as defined in 45 CFR 164.501), without a written authorization, as 
specified in the Privacy Rule. For example, a covered entity may use or 
disclose protected health information to the extent such use or 
disclosure is required by law (45 CFR 164.512(a)). A covered entity may 
disclose protected health information to a public health authority 
authorized by law to collect or receive such information for the 
purposes (among others) of conducting public health surveillance, 
public health investigations, and public health interventions (45 CFR 
164.512(b)(1)(i)). In addition, a covered entity may disclose protected 
health information to a health oversight agency for oversight 
activities authorized by law including audits, investigations, and 
inspections (45 CFR 164.512(d)). Accordingly, complainants (who are 
also covered entities) could submit the complaint form to FDA 
consistent with the Privacy Rule.
    The comment stated that although the consent form for a clinical 
trial should indicate the number of subjects planned for enrollment, it 
seems unlikely that any one subject would know how many subjects were 
actually enrolled.
    (Response) If a complainant does not know ``how many subjects were 
enrolled in the study(ies),'' they need not record any information in 
that field on the complaint form. It is important to note that the 
complainant is not always a study subject. Sometimes, study 
coordinators or monitors who are familiar with the number of subjects 
enrolled in a study may submit the complaint.
    The comment objected to complainants being given the option to 
report anonymously. The comment stated that complainants should be 
willing to identify themselves to FDA and should be assured that their 
identities will not be disclosed.
    (Response) FDA currently receives several anonymous complaints 
among the 150 complaints that it receives (via mail and phone contacts) 
each year regarding alleged scientific misconduct in clinical research. 
The complaint form does provide complainants the option to reveal their 
identity. However, FDA believes that complainants should also have the 
option to remain anonymous. Although FDA makes a good faith effort to 
protect the identities of complainants, no assurance can be given to 
complainants that their identity will never be disclosed. It is also 
important to note that the complainant is not always a study subject. 
Sometimes, study coordinators or monitors may submit the complaint and 
would like to remain anonymous for fear of retribution or retaliation.
    The comment stated that although the use of an Internet-based form 
would appear to simplify the collection of complaints, the form as 
currently proposed would not do so. FDA would need to publicize the 
availability of the form, explain its intent, revise the form's 
content, and provide instructions for the form's completion in order to 
make the Internet-based form a viable addition to existing routes 
through which complaints are currently captured.
    (Response) As mentioned previously in this document, FDA believes 
that the Internet-based complaint form will simplify the collection of 
complaints. In addition, work is in progress to automate the data 
transfer from valid complaint forms into a complaint database, which 
would save personnel resources that would otherwise be needed to 
manually record and track complaints. In addition, the automation would 
reduce the potential for transcription errors and enhance DSI's ability 
to track complaints. FDA will publicize the availability of the 
Internet-based complaint form, explain its intent, revise the form's 
content as necessary, and provide instructions for the form's 
completion in order to make the Internet-based complaint form a viable 
addition to existing routes through which complaints are currently 
captured. It is FDA's intention that the Internet-based complaint form 
will minimize the paperwork burden for complainants, minimize the cost 
to the Federal government of the collection, maintenance, use, and 
disposition of information, and ensure that information technology is 
used to improve performance of agency missions, including the reduction 
of information collection burdens on the public.
    (Comment 2) A second comment suggested that we change the 
introductory statement from ``If you wish to report side effects to 
drugs or other medical products * * *'' to ``If you wish to report 
adverse reactions or medical product problems contact MEDWATCH.'' The 
comment stated that MEDWATCH is an adverse event and product problem 
reporting system, and is typically not used to report side effects that 
are listed in the product's labeling but rather report serious adverse 
events not included in the labeling or minimally described in the 
labeling.
    (Response) The introduction to the complaint form has been revised 
as follows to state: ``If you wish to report adverse events (adverse 
effects or adverse reactions) to drugs or report (medical) product 
problems contact MedWatch.''
    The comment recommended that the introduction to the form include a 
statement about the purpose of the form e.g., ``the purpose of this 
form is for the agency to collect important information about the 
potential scientific or research misconduct, or questionable research 
practices, involving the use of an FDA-regulated product.'' The comment 
stated that without this disclaimer, FDA will likely obtain irrelevant 
information that is not under FDA, specifically BIMO, purview.
    (Response) The following statement of purpose has been added to the 
introduction in order to obtain more specific information: ``The 
purpose of this form is for collecting information about potential 
scientific or research misconduct, or questionable research practices, 
involving the use of a FDA regulated drug product.''

[[Page 74821]]

    The comment suggested inserting an e-mail address field.
    (Response) The complaint form as designed does provide a field for 
the complainant to provide an e-mail address. FDA has revised the form 
to add an option for a complainant to provide the email address of the 
person they are complaining about.
    The comment asked whether FDA had a specific interest in collecting 
information about coinvestigators or subinvestigators.
    (Response) FDA is interested in collecting complaints about 
subinvestigators and study personnel involved in the conduct of 
clinical investigations, and the complaint form provides the option for 
a complainant to provide ``Other'' information about persons or 
entities that are not specifically included as data fields with radio-
buttons. Hence, there would be no need for adding additional radio-
buttons for coinvestigators or subinvestigators.
    The comment suggested using ``Clinical Study Site'' to be more 
clear.
    (Response) The complaint form will be revised to replace the use of 
``Clinical Site'' with ``Clinical Study Site''. In addition, the 
complaint form will be revised to replace ``Site Employee'' with 
``Employee'' under the question ``What is your affiliation with the 
study?''
    The comment asked whether the data collection is limited to good 
clinical practices (GCPs) and good laboratory practices (GLPs), and 
whether it pertains to current good manufacturing practices (CGMPs).
    The comment recommended adding a check box so the complaint can be 
appropriately triaged to the correct office (e.g., that handles GCPs, 
GLPs, or CGMPs) within the appropriate Center.
    (Response) It is anticipated that the complaints submitted to DSI 
will mostly pertain to GCPs and GLPs related to clinical studies 
involving FDA regulated drug products. The data collection is not 
intended to include CGMP issues. DSI will forward any complaints 
pertaining to CGMP issues to the appropriate divisions within FDA. 
Hence, the addition of a check box for CGMP does not offer any 
advantage and will not be added.
    The comment suggested that FDA modify the question ``What is your 
complaint?'' to be more clear, and suggested that it be replaced with 
``What information do you have that relates to questionable research or 
scientific misconduct with an FDA regulated product (biologic, device, 
drug, food, etc.).''
    (Response) The question on the complaint form ``What is your 
complaint?'' is the most direct approach to eliciting the required 
information from a complainant. Hence, no modification of the question 
is necessary.
    The comment recommended revising two existing questions to: ``What 
was the approximate timeframe related to the event to which you are 
reporting?''
    (Response) The pertinent questions currently on the complaint form 
``When did the event(s) take place?'' and ``When did you participate in 
the study?'' are the most direct approach to eliciting the required 
information from a complainant. Hence, no modification of these 
questions is necessary.
    The comment suggested the insertion of a series of checkboxes, 
similar to the person or organization about which they are complaining, 
to indicate the type of regulated product. The comment stated that this 
will facilitate a quick triage to the appropriate center within FDA.
    (Response) The form is for collecting complaints regarding FDA 
regulated drug products and is intended to be an adjunct to DSI's 
existing methods of collecting complaints. We do not anticipate 
receiving complaints about other FDA regulated products and hence do 
not need to insert additional checkboxes. If DSI receives complaints 
that pertain to other FDA regulated products, they will be forwarded to 
the appropriate center within FDA. The addition of check boxes is not 
likely to enhance or expedite this process.
    The comment suggested using the question ``What is the name(s) of 
the medical products related to your report?'' to prompt the entry of 
brand name, trade name, generic name, and so forth.
    (Response) The comment pertains to the complaint form question 
``What is/are the name(s) of the study drug(s) or product(s), if 
known?'' The question currently on the complaint form is the most 
direct approach for eliciting the required information from a 
complainant. Modifying the question as suggested may unnecessarily 
confuse the complainant.
    The comment suggested using the question ``What is the indication 
or intended use for the product?'' to query the intended use of the 
product. The comment noted that not all medical products are used to 
treat illness.
    (Response) The comment pertains to the complaint form question 
``What is the type of drug or for what illness is it used (e.g., a drug 
to treat chest pains, seizures, depression, etc.)?'' The question 
currently on the complaint form is the most direct approach to 
eliciting the required information from a complainant. The general 
population will not readily understand the use of words such as 
``indication'' and ``intended use.''
    The comment recommended that the complaint form be reformatted to 
use separate entry screens for e-mail, phone, fax, and so forth.
    (Response) The comment pertains to the section of the complaint 
form entitled ``Your information.'' FDA agrees with the comment and 
will modify this section to include separate entry screens for e-mail, 
phone, and fax numbers. In addition, FDA will modify the same section 
to include separate entry screens for recording address(es), city, 
state or province, zip code, and country.
    The comment suggested that the form should spell out such terms as 
``Institutional Review Board'' and ``Contract Research Organization,'' 
and should also include ``clinical investigator.''
    (Response) A radio button will be added for ``clinical 
investigator,'' and all abbreviations will be spelled out in the 
complaint form and as suggested by the comment.
    (Comment 3) Another comment suggested that FDA use one research 
complaint form that would cover all FDA-regulated products. An example 
would be the MEDWATCH form. This would be much simpler for the public 
to use rather than each center within FDA creating their own form and 
related process. Additionally, it would bring research complaints 
associated with all FDA regulated investigational products to the 
agency's attention, thus making it easier to track and subsequently 
measure outcomes.
    (Response) The purpose of this form is to collect information about 
potential scientific or research misconduct, or questionable research 
practices, involving the use of a FDA regulated drug product. It is 
anticipated that complaints submitted to DSI will mostly pertain to 
GCPs and GLPs related to clinical studies involving FDA regulated drug 
products. The data collection is not intended to include complaints 
pertaining to all FDA regulated products. DSI will forward any 
complaints regarding other FDA regulated products that are not under 
DSI's purview to appropriate divisions within FDA. The development of a 
universal research complaint form that covers all major FDA regulated 
products may offer advantages as suggested in the comment but would 
require substantial staff to redirect complaints.


[[Page 74822]]


    Dated: December 8, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-24102 Filed 12-15-05; 8:45 am]
BILLING CODE 4160-01-S