[Federal Register Volume 67, Number 200 (Wednesday, October 16, 2002)]
[Notices]
[Pages 63928-63929]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-26324]



[[Page 63928]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0131]


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request; FDA Rapid Response Surveys

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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

DATES: Submit written comments on the collection of information by 
November 15, 2002.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Stuart Shapiro, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Mark L. Pincus, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1471.

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.

FDA Rapid Response Surveys--New Collection

    Section 505 of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 355), requires that important safety information relating to 
all human prescription drug products be made available to FDA so that 
it can take appropriate action to protect the public health when 
necessary. Section 702 of the act (21 U.S.C. 372) authorizes 
investigational powers to FDA for enforcement of the act.
    Under section 519 of the act (21 U.S.C. 360i), FDA is authorized to 
require manufacturers to report medical-device-related deaths, serious 
injuries, and malfunctions to FDA and to require user facilities to 
report device-related deaths directly to FDA and to manufacturers, and 
to report serious injuries to the manufacturer. Section 522 of the act 
(21 U.S.C. 360l) authorizes FDA to require manufacturers to conduct 
postmarket surveillance of medical devices. Section 705(b) of the act 
(21 U.S.C. 375(b)) authorizes FDA to collect and disseminate 
information regarding medical products or cosmetics in situations 
involving imminent danger to health or gross deception of the consumer. 
Section 903(d)(2) of the act (21 U.S.C. 393(d)(2)) authorizes the 
Commissioner of Food and Drugs to implement general powers (including 
conducting research) to carry out effectively the mission of FDA. These 
sections of the act enable FDA to enhance consumer protection from 
risks associated with medical products usage that are not foreseen or 
apparent during the premarket notification and review process.
    FDA's regulations governing application for agency approval to 
market a new drug (21 CFR part 314), regulations governing biological 
products (21 CFR part 600, et seq.), and regulations governing medical 
devices (21 CFR part 803) implement these statutory provisions.
    Currently FDA monitors medical product related postmarket adverse 
events via both the mandatory and voluntary MedWatch Reporting Systems 
using FDA Forms 3500 and 3500A (OMB control number 0910-0291), and the 
Vaccine Adverse Event Reporting System (VAERS).
    FDA is seeking OMB clearance to collect vital information via a 
series of rapid response surveys. Participation in these surveys will 
be voluntary. This request covers rapid response surveys for community 
based health care professionals, general type medical facilities, 
specialized medical facilities (those known for cardiac surgery, 
obstetrics/gynecology services, pediatric services, etc.), other health 
care professionals, patients, consumers, and risk managers working in 
medical facilities.
    FDA will use the information gathered from these surveys to obtain 
quickly vital information about medical product risks and interventions 
to reduce risks so the agency may take appropriate public health or 
regulatory action including dissemination of this information as 
necessary and appropriate.
    In the Federal Register of April 30, 2002 (67 FR 21253), the agency 
requested comments on the proposed collection of information. FDA 
received four comments, but only one pertained to the information 
collection.
    For the purpose of clarity and understanding, the comment will be 
divided into six sections. The first section is as follows:
    The previous notice provides no description of the surveys being 
proposed, the nature of the information to be sought, the respondents 
to whom the surveys will be sent, the ``triggers'' for issuing survey, 
or proposed use of the results of these surveys.
    FDA's response is there have been times when FDA has received 
notice of medical product problems through its various adverse event-
reporting systems and often there is insufficient information to gauge 
whether or not a significant public health problem exists with respect 
to a specific medical product. If a significant problem exists, FDA 
seeks to understand quickly the nature of the problem.
    FDA will propose the use of specific FDA Rapid Response Surveys 
through the submission of a memorandum requesting OMB approval of the 
survey. Included in this memorandum will be the need for the survey and 
the timeframe in which FDA needs OMB to make a decision on the survey, 
and the description of the statistical methods to be used. These 
include the respondent universe, the sample selection methods, the 
information collection procedures, the expected response rate and an 
estimate of the burden. Also included in the request will be a copy of 
the survey.
    Also, if there is a very new problem to FDA, the agency needs to 
investigate it more before it decides on the proper action. For 
example, if the results of the survey indicate that problems are more 
widespread than just a few isolated incidents, the first anticipated 
action by FDA is to contact the manufacturers or sponsors of the 
product to discuss the issues. Depending on the manufacturers' 
responses, the issue could end up in a product recall, or information 
could be posted on the FDA web site stating that some problems exist 
with the use of these products. Additionally, the issue may be referred 
to a center ad-hoc committee or a working group to formulate additional 
actions. Without first knowing if there is an issue, and what the 
causes of the problem may be, it is difficult to state the final 
action. That is why the Rapid Response Survey becomes so important in 
helping FDA discern the issues.
    By going to the manufacturers and sponsors, FDA often needs input 
from other stakeholders that have firsthand knowledge of the problem 
and the situation. Here is where the Rapid Response Survey can be 
invaluable.
    The second section of the comment recommends that the notice be 
reissued with adequate details about the proposed collection of 
information to

[[Page 63929]]

enable the public to understand the proposal so that comments can then 
be made to the agency based on full knowledge of the proposal.
    FDA responds to the comment by stating in the 30-day Federal 
Register notice and in the information collection requirement adequate 
details about the purpose were added to enable the public to understand 
the purpose of the proposal. Therefore, FDA is not going to reissue the 
60-day Federal Register notice, but has considered and responded to all 
the comments received.
    The third section of the comment states that risk management 
requires the involvement of all stakeholders, including government, 
industry, health-care professionals, and patients. The role of medical 
product sponsor appears to be left out of the process.
    FDA's response is that medical product sponsors as a stakeholder 
was omitted inadvertently from the 60-day Federal Register notice 
seeking public comment. They will be included in the 30-day Federal 
Register notice announcing FDA's submission of this information 
collection to OMB as well as in the justification package sent to OMB.
    The fourth section of the comment states that it is unclear to whom 
the surveys will be directed. Although the notice identifies general 
groups, there is no discussion of how members of these groups will be 
identified to participate in the surveys.
    The FDA reply is that the agency will determine which groups to 
which groups will be asked to participate in each particular survey 
based on the type of medical product problem that occurred. For 
instance, if the problem dealt with clinical laboratory devices and a 
perceived problem with antibody assays for detection of the herpes 
virus and laboratory information systems mixing up pathology reports, 
FDA would survey the members of the American Society of Microbiology 
Division C and facilities that use such information that is retrieved 
from the MedSun system.
    Section five deals with the voluntary nature of the surveys risks 
the collection of potentially confounded, biased, and unconfirmed 
information on which, according to the notice, the agency intends to 
``take: appropriate public health or regulatory action.''
    FDA responds that usually it expects a 70 percent response rate. 
The impact of a lower response rate to these surveys will be considered 
before FDA takes action to improve the response rate. FDA may determine 
that quicker action--development of a public position paper--can be 
taken based on consistent responses from each of the surveys conducted. 
If there is a low response rate with no clear pattern of response, the 
national organization representing that stakeholder group will send a 
letter to all respondents reminding them to fill out the survey form.
    FDA proposes to draw purposeful samples for these surveys. Since 
the survey data will not be used for estimates of incidence, there is 
no need for a probability sample. Because these proposed data 
collections are qualitative, not quantitative, and because FDA 
resources for processing incoming data limited, FDA proposes to keep 
these data collection efforts to a manageable size.
    The response universe will be kept to those stakeholders that have 
been identified as appropriate respondents. These will be groups that 
focus on those specialties and have experience and expertise in those 
areas.
    The sixth and final section of the comment stated that the notice 
doesn't address the mechanism by which the surveys will produce ``rapid 
responses'' from those surveyed. Whether the surveys will be conducted 
by mail, facsimile, telephone, or the Internet, there is a need to 
validate the source(s) and medical accuracy of the information 
provided. One of the hallmarks of responsible risk management is 
confirmation of the information upon which decisions are based. 
Decision should not be based on information gathered in haste if/when 
the source and validity of the data have not been confirmed.
    FDA's response is depending on the criticality of the survey and 
the speed in which the data needs to be returned to FDA, respondents 
can use mail, faxes, or e-mail for their survey responses. More use of 
Internet based surveys will be made in the future.
    FDA will employ great care in determining the validity of the 
information received. This will be done through the design of the 
survey instruments and keeping identifiers for followup if the Center 
has concerns about the data received. After the data has been verified, 
the respondents identifying information will be deleted.
    FDA estimates the burden of this collection of information as 
follows:

             Table 1.--Estimated Annual Reporting Burden\1\
------------------------------------------------------------------------
               Annual
   No. of    Frequency     Total Annual       Hours per
Respondents     per      [chyph]Responses     Response      Total Hours
              Response
------------------------------------------------------------------------
200          30             6,000                 .5        3,000
              (maximum
              )
------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs
  associated with this collection of information.

    FDA projects 30 emergency risk related surveys per year with a 
sample of between 50 and 200 respondents per survey. FDA also projects 
a response time of 0.5 hours (30 minutes) per response.
    These estimates are based on the maximum sample size per 
questionnaire that FDA can analyze in a timely manner. The annual 
frequency of response was determined by the maximum number of 
questionnaires that will be sent to any individual respondent. Some 
respondents may be contacted only one time per year, while other 
respondents may be contacted several times annually, depending on the 
human drug, biologic, or medical device under evaluation. It is 
estimated that, given the expected type of issues that will be 
addressed by the surveys, it will take 0.5 hours (30 minutes) for a 
respondent to gather the requested information and fill in the answers.

    Dated: October 9, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-26324 Filed 10-15-02; 8:45 am]
BILLING CODE 4160-01-S