[Federal Register: December 16, 2005 (Volume 70, Number 241)]
[Notices]
[Page 74817-74822]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16de05-74]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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
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\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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.hhs.gov), FDA Web site(http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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