SUPPORTING STATEMENT FOR FDA RAPID RESPONSE SURVEYS

INFORMATION COLLECTION

# A. [Justification]{.underline}

1.  **[Circumstances Making the Collection of Information
    Necessary]{.underline}**

> The Food and Drug Administration (FDA) is requesting approval from the
> Office of Management and Budget (OMB) for a generic clearance to
> implement a medical product information collection program, FDA Rapid
> Response Surveys. The purpose of the requested information collection
> program is to provide a tool to obtain quickly vital information from
> the appropriate clinical sources so that FDA may take appropriate
> public health or regulatory action.
>
> This program will obtain data on safety information to support
> quick-turnaround decision-making about potential safety problems or
> risk management solutions. This information will be collected from
> health professionals, hospitals, and other user facilities (e.g.,
> nursing homes, ambulatory surgical facilities and outpatient
> diagnostic and treatment facilities, etc.), consumers, sponsors and
> manufacturers of biologics, drugs and medical products, distributors,
> and importers when FDA must quickly determine whether or not a problem
> with a medical product impacts the public health. While the form for
> data collection will be standardized (please see Attachment A --
> Standardized Form), the actual information to be collected will vary
> from survey to survey. The specific information FDA needs for
> risk/management or hazard analysis will depend on the medical product
> in question and the particular adverse event under investigation.
> Responses to the information-collection questions are strictly
> voluntary and anonymous.
>
> FDA is the regulatory agency responsible for the safety and
> effectiveness of medical products including biologics, drugs, foods,
> cosmetics, medical products, radiological products, and animal drugs.
> Important questions about medical products, such as those concerning
> user experience, durability, and rare effects may not be answered
> until after the product has been marketed. To protect the public
> health, FDA must be able to collect rapidly information pertaining to
> adverse events associated with medical products after they have been
> marketed.
>
> 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 made available to the 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 of the FDA for the enforcement of the Act.

Under section 519 of the Act (21 U.S.C. 360(i)), FDA is authorized to
require manufacturers to report medical device related deaths, serious
injuries, and malfunctions and to require user facilities (hospitals,
nursing homes, ambulatory surgical facilities and outpatient diagnostic
and treatment facilities) to report medical 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. 360(l)) authorizes FDA to require
manufacturers to conduct postmarket surveillance of medical devices.

Section 705(b) of the Act (21U.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) (C) of the Act (21 U.S.C. 393(d)(2)(C)) authorizes the
Commissioner of Food and Drugs (the Commissioner) to implement general
powers (including conducting research) to carry out effectively the
mission of the FDA.

These sections of the Act enable FDA to enhance consumer protection from
risks associated with medical product usage that are not foreseen or
apparent during the application, premarket notification and review
process.

FDA's regulations governing applications for agency approval to market a
new drug (part 314 (21 CFR part 314)), regulations governing biological
products (part 600, et. seq. (21 CFR part 600, et. seq.)), and
regulations governing medical devices (part 803 (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 System.
> Using FDA forms 3500A (mandatory form) and 3500 (voluntary form): OMB
> Control Number: 0910-0291, and Form VAERS-1 for the Vaccine Adverse
> Event Reporting System (VAERS), all reports are submitted to FDA.

Over the years, medical science and technology have become increasingly
complex. Due to economic pressures and organizational changes within
health care organizations, this science and technology is not only used
by highly trained health care professionals, but has also moved into
facilities where the users may not be as sophisticated. Additionally,
many of these increasingly complex drugs and medical products are now
found in the home. These changes have increased the need to obtain
timely information from postmarket surveillance systems and to
disseminate quickly information to the health care and consumer
communities on public health safety issues.

> Analysis of a potential health or medical problem often cannot be made
> based on the information contained in a few adverse event reports
> submitted through the MedWatch program. While section 522 of the Act
> gives FDA the authority to instruct manufacturers to conduct
> surveillance of medical devices and sections 702 and 903 to
> investigate and to conduct research to allow FDA to enforce the Act
> and to carry out the mission of the Agency. For instance, for devices,
> it can take up to 90 days before the surveillance plan is begun (i.e.
> the manufacturer has 30 days after receiving notification that FDA is
> requesting surveillance of a particular product to submit a
> surveillance plan, and FDA then has 60 days to accept the plan), and
> much longer until the plan has been completed. This link to the
> manufacturing community does not fulfill the need for rapid
> information when FDA must decide quickly if particular adverse event
> reports signal a widespread public health problem. FDA requires a
> timely link to the clinical community in order to obtain information
> for more emergent situations.
>
> The reports of adverse events that FDA receives from the clinical
> community typically are not complete and hence there is considerable
> underreporting. When necessary, FDA contacts the individual reporter
> of a particular adverse event to obtain more information than what was
> provided in the MedWatch report. However, there is often insufficient
> information from the reporter to determine whether an adverse event
> signals a potential public health hazard. Lack of sufficient
> information often hampers FDA\'s ability to understand quickly and
> thoroughly and evaluate the problem; determine the factors that
> contributed to the adverse event; determine the scope of a possible
> public health problem; and determine what steps must be recommended to
> the health-care community to prevent further injury.
>
> In order to perform risk analysis and determine the appropriate action
> plan, FDA must have the tools to investigate fully medical product
> problems. Therefore, FDA proposes implementing an information
> collection program, FDA Rapid Response Surveys, which will provide the
> necessary timely link to the clinical community**.**
>
> This program will consist of no more than 30 rapid response survey
> questionnaires each year. The questionnaires will be sent to
> appropriate medical professionals, health care institutions,
> consumers, sponsors, manufacturers and/or importers of medical
> products. The data collected will provide FDA with information to
> allow a more complete analysis of the problem; determine the existence
> and extent of a public health problem; and then, if necessary, to
> disseminate the information to the health care community. All of these
> processes must be accomplished in a timeframe that limits, to the
> extent possible, further incidents causing injury to the public.
>
> The standard survey form will be used, with the addition of questions
> that specifically address the medical product problem under
> investigation. Prior to sending out the survey, FDA will send a
> memorandum with the survey attached to OMB for its sign-off. Due to
> the necessary rapid turnaround of the survey, it is hoped that the
> sign-off may be obtained within 3 to 10 days.
>
> **2.** **[How, by Whom and For What Purpose the Information is to be
> Used?]{.underline}**
>
> FDA monitors the reports of adverse events associated with the use of
> medical products that enter the MedWatch mandatory and voluntary
> reporting programs. Reports are triaged based on perceived risk to the
> patient. Some reports signal an immediate hazard, but more commonly it
> is the experienced FDA clinical analysts that detect product problems,
> particularly those related to product use, through careful
> investigation of reported incidents and searching for additional
> sources of information.
>
> The degree of perceived risk to the public is the most important
> consideration for any FDA public health action (product recall, Safety
> Alert, Public Health Notification, Ad Hoc Committee, workshop,
> publication, etc.) It is imperative that these risk determinations are
> completed as quickly as possible to avoid further deaths or injuries
> from occurring. Currently, FDA analysts makes these determinations
> based on information contained in adverse event reports; obtained from
> contacting the individuals who made the reports; gathered from
> expertise of scientists within, and sometimes outside, the agency; and
> from any other data sources available.
>
> When these data sources fail to provide enough information to perform
> a risk/hazard analysis, FDA proposes to use the FDA Rapid Response
> Surveys to answer these important questions. The variety of problems
> seen with medical products dictates that each survey effort will be
> unique in that each will involve a different type of product used by
> different health care professionals. For example: an adverse event
> report may be received describing an anaphalatic-type reaction during
> the use of a certain catheter. Evaluation of this problem includes
> questions such as: was this reaction related to the patient\'s illness
> or the stress of the procedure; and is therefore not medical product
> related or, is there a biomaterial in this medical product that could
> cause this reaction? Because the health care community often does not
> recognize that a product may have contributed to an adverse event and
> because there is significant underreporting, it is critically
> important to know whether other health care professionals may have
> seen this problem. These other professionals may have not reported a
> similar event because they did not recognize that the reaction might
> have been related to the product. If FDA has the ability to survey
> quickly the appropriate user population (in the example cited, this
> would be the IV Nurses Association), FDA could immediately determine
> if the report was an isolated incident or had occurred more often and
> was a signal of a potentially serious problem with the product.
>
> FDA proposes to contact the facilities, health care professionals,
> sponsors, manufacturers, and importers of medical products
> electronically, whenever possible, or by mail, using an internal
> mailing list, or obtaining such a list from the professional
> associations which represent the different groups of health-care
> professionals. FDA has excellent relationships with national
> professional health care associations that also serve state chapter
> associations; these national organizations are willing to provide
> assistance in contacting their individual members when their members\'
> expertise will be required to respond to specific surveys.
>
> As noted, above, the targeted population to respond to the particular
> survey questions, and the specific survey questions, will change
> depending on the particular product in question.
>
> The data will be collected and analyzed by the Agency's postmarketing
> surveillance offices conducting the Rapid Response Survey. Public
> health analysts and epidemiologists, and when necessary, statisticians
> and other Agency scientists, will analyze the data to determine
> whether a public health risk exists, and how it must be addressed.
>
> **3. [To What Extent the Collection of Information involves the use of
> Automated, Electronic, Mechanical, or Other Technological Collection
> Techniques]{.underline}**
>
> The methodology for contacting the reporting sample will vary
> depending on the product and the health professionals and others
> targeted as respondents. Some of the data collections will involve
> mailings from FDA, some will be accomplished with the help of
> professional associations (either direct mailouts from the
> associations to its members, or the associations may provide contact
> lists to FDA), and some will be conducted electronically.
>
> Whenever possible, and on a small scale, and to avoid the burden of
> responding by mail, electronic collections will be conducted. For
> example, as directed by the Food and Drug Modernization Act of 1997,
> FDA is developing a \"sentinel\" system to represent the various types
> of user facilities in the United States. In order to comply with the
> Government Paperwork Elimination Act of 1998, these facilities will
> report to FDA via the Internet, and FDA will have the ability to
> contact the sites via e-mail. This system is currently in place, will
> eventually represent a group of hospitals, nursing homes, home health
> care agencies, and other medical product user facilities. The risk
> managers at different groups (hospitals, nursing homes, etc.) of these
> sentinel sites would function as the sample when the product in
> question is used at their type of facility.
>
> **4. [Describe Efforts to Identify Duplication]{.underline}**
>
> FDA scientists routinely utilize literature searches and other
> secondary data sources to aid in answering some questions about the
> use of medical products. However, many of the product issues relate to
> emerging technologies and sciences where little has been written about
> these problems. FDA's surveillance system is a large national system
> that is designed to pick up not only common problems, which may appear
> in the literature, but more importantly, to pick up signals for
> seemingly rare events that may have far reaching public health
> implications. These rare events usually have not been identified
> previously, or when they do appear in a journal, they are reported as
> "case studies" which do not provide FDA with the broader scope needed
> to define the public health impact.
>
> Manufacturers are contacted routinely to learn of their experience in
> investigating and evaluating particular issues. Additionally, FDA
> scientists contact other public and private health organizations and
> associations, such as the Center for Disease Control, Product Quality
> Research Institute, American Association of Pharmaceutical Scientists,
> Generic Pharmaceutical Industry Association, National Association of
> Pharmaceutical Manufacturers, Nonprescription Drug Manufacturers
> Association, National Pharmaceutical Alliance, Parenteral Drug
> Association, Pharmaceutical Research and Manufacturers of America,
> American College of Radiology, Senior Citizen Groups, or ECRI
> (formerly the Emergency Care Research Institute), to determine if the
> databases maintained at those organizations contain any useable
> information. In addition, FDA will contact other experts in science,
> medicine and public health as well as consumers, product sponsors and
> manufacturers, importers, and retailers.
>
> While these outreach efforts can be useful, they may not be complete
> enough to aid FDA in determining rapidly the exact nature and public
> health impact of a problem. Therefore, FDA needs the additional tool
> of the information collection proposed in the FDA Rapid Response
> Surveys requested in this document.
>
> **5. [Small Business]{.underline}**
>
> It is possible, but unlikely; that respondents contacted will be small
> businesses. Most medical product adverse events that will be under
> investigation are rare events, and larger institutions are more likely
> to have experience with these medical products. In the event that
> smaller entities are included in a survey, their participation will be
> voluntary and the burden estimated as no more than .5 hours per
> respondent.
>
> **6**. **[Describe consequences to Federal program or policy if the
> collection is not conducted]{.underline}**
>
> The FDA postmarket surveillance program will be less effective in
> providing timely, necessary information to the health care community
> on avoiding serious injuries and deaths with medical products for
> those products whose problem mechanisms are not well understood and
> for which FDA has no tool to obtain needed information.
>
> To demonstrate the importance of establishing a Rapid Response Survey
> information collection program**,** a sample survey is provided
> (Attachment B). This sample demonstrates when an immediate means of
> information collection would have resulted in more effective, timely
> feedback to the public.
>
> **7. [Special Circumstances]{.underline}**
>
> Requiring respondents to prepare a written response to a collection of
> information in fewer than 30 days after receipt of the questionnaire.
>
> Given the need for FDA to obtain information about possible risks to
> the public health in a rapid timeframe, 30 days will be the outside
> limit of the requested length of time to respond. If there is the
> possibility of a public health emergency, respondents may be asked to
> respond within 15 days. For any necessary shorter turnaround
> timeframes, electronic contact will be made to encourage faster
> responses.
>
> **8. [Describe efforts to consult with person outside the agency to
> obtain their views on the availability of data, etc.]{.underline}**
>
> It is anticipated that the primary respondents to the information
> collection program questionnaires will be risk managers working
> primarily at hospitals. Therefore, the organization representing this
> group, the American Society for Healthcare Risk Management (ASHRM) was
> contacted to obtain its opinion about the program.
>
> Results of this contact:
>
> ASHRM strongly emphasized the need for the surveys to be voluntary and
> anonymous, with absolutely no traceable links back to the respondents
> including no facility profile information; that the surveys be as
> short and "pithy" as possible; and, to maximize the input into the
> process and to promote learning within the institution, that the
> respondents send the survey information through the facilities'
> internal quality improvement systems.
>
> Prior to issuing the Federal Register Notice, FDA accommodated these
> suggestions to the extent possible. There may be situations when it
> will be important to ask some very general facility profile
> information (region of the country, bed-size, etc.). However, FDA will
> ensure that the information requested is divided into very broad
> categories, so the anonymity of the respondents will not be breached.

In accordance with 5 CFR 1320.8(d), on Tuesday, April 30, 2002, (67 FR
21253), a 60-day notice for public comment (Attachment C) was published
in the Federal Register. 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: That 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 simply posting information on the FDA web
site that some problems exist with the use of these problems.
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 first hand 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
re-issued with adequate details about the proposed collection of
information to 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 re-issue 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 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 the Office
of Management and Budget 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 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 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% 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 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 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 to for their survey responses. More use of
Internet based surveys will be made in the future.

> FDA will employ great care in their determination of the validity of
> the information received. This will be done through the design of the
> survey instruments and keeping identifiers for follow-up if the Center
> has concerns about the data received. After the data has been
> verified, the respondents identifying information will be deleted.
>
> **9. [Explanation of Any Payment or Gift to Respondents]{.underline}**
>
> Respondents will receive no gift or payment for their participation in
> the questionnaires.
>
> **10. [Assurance of Confidentiality (Anonymity) Provided to
> Respondents]{.underline}**
>
> The identity of the respondent providing information to the FDA Rapid
> Response Surveys will be anonymous.
>
> Written or electronic questionnaire forms sent from FDA will not ask
> for identifying information and they will not be coded in any way that
> will identify the respondent. Therefore, FDA will not know the
> identity of the respondent to any returned form. E-mail surveys will
> give clear directions that the responses are not to be returned via
> e-mail. To avoid creating a link between the respondents' responses
> and the respondents, the surveys must be copied from the e-mail, and
> faxed or mailed to FDA. Identifiers on faxed data will be removed and
> return envelopes will be destroyed before the information is given to
> the analysis team.
>
> Whenever possible, we will work through a third party (i.e. health
> care association) so that the third party may contact a particular
> respondent for follow-up when necessary, while still keeping the
> identification of the respondent unknown to FDA.
>
> Lists of all responder samples used for each inquiry will only be held
> long enough to determine the response rate and to re-contact each
> respondent if we have not achieved a response rate that permits FDA
> scientists to judge whether a public health hazard exists. Lists will
> be destroyed following the data collection and any necessary follow-up
> so no possible link may be made between the obtained information and
> the respondent. For more detail concerning follow-up of
> non-responders, please see Part B, Section 3.
>
> **11. [Justification for Sensitive Questions]{.underline}**
>
> None of the questions will be sensitive in nature.
>
> **12. [Estimates of Hour Burden Including Annualized Hourly
> Costs]{.underline}**
>
> This is based on the maximum number of surveys (highly likely that
> this maximum will not be reached\--most respondents will probably
> never be contacted more than 5 times per year due to the variable
> nature of the medical product issues and the need to access different
> respondent groups).
>
> [Estimated Annual Reporting Burden]{.underline}

+-------------+------------+-------------+-------------+-------------+
| Number of   | Annual     | Total       | Hours per   | Total Hours |
| Respondents | Frequency  | Annual      | Response    |             |
|             | of         | Responses   |             |             |
|             | Responses  |             |             |             |
+-------------+------------+-------------+-------------+-------------+
| 200         | 30         | 6,000       | .5          | 3,000       |
|             |            |             |             |             |
|             | (maximum)  |             |             |             |
+-------------+------------+-------------+-------------+-------------+

> [Annualized Hourly Costs]{.underline}
>
> Risk managers working in hospitals will complete the majority of the
> surveys. The average salary of this professional group is \$34.00 per
> hour. The estimated annualized annual cost for 3,000 hours of
> reporting time is \$102,000.00.
>
> [Derivation of numbers]{.underline}:
>
> [Number of Respondents]{.underline} is determined by the maximum
> sample size of 200 facilities (or individuals) per questionnaire. This
> number will vary depending on the medical product under evaluation.
> Data from more than 200 sources could not be evaluated in a rapid
> timeframe.
>
> [Annual Frequency of Responses]{.underline} is determined by the
> maximum number of questionnaires that will be sent to any individual
> respondent. As noted earlier, some respondents may be contacted only 1
> time per year, while another respondent may be contacted several times
> depending on the medical product under evaluation.
>
> [Total Annual Responses]{.underline} is 200 facilities/sample x 30
> questionnaires = 6000 (unlikely this maximum will be reached).
>
> [Hours/Responses]{.underline} is estimated that at a maximum, it will
> take .5 hours for a respondent to gather the requested information and
> fill in the answers.
>
> [Total Hours]{.underline} is 6,000 annual responses x .5
> hours/response = 3,000 hours.
>
> **13. [Estimate of Other Total Annual Cost Burden to
> Respondents]{.underline}**
>
> There will be no costs incurred by respondents.
>
> **14. [Annual Cost to the Federal Government]{.underline}**
>
> It is anticipated that half of the total number of surveys per year
> will be issued via e-mail, and the remaining half will be conducted
> via mailings. Using the maximum number of 30 surveys per year, costs
> listed below are for 15 surveys conducted by e-mail and 15 by mail.
>
> The cost of administrative help to develop the respondent lists and
> obtain e-mail addresses is \$2,400.00. This represents .06 FTE for 120
> hours at a cost of \$20.00 per hour (includes administrative costs).
>
> For the 15 surveys conducted by mailings, the cost to the government
> for administrative help to create respondent lists, photocopy, and
> stuff envelopes is \$1,620.00. This represents .03 FTE for 81 hours at
> a cost of \$20.00 per hour (includes administrative costs).
>
> The cost of postage will be \$2,220.00 (to send out 3000 envelopes and
> for the return postage); the cost of envelopes will be \$150.00 (3000
> mailed from FDA, and FDA will provide return envelope); and the cost
> of paper will be \$81.00. [**Total Cost**: **\$6,471.00**]{.underline}
>
> **15. [Explanation for Program Changes or Adjustments]{.underline}**
>
> This information collection is an expansion of the Rapid Response
> Surveys: OMB No. 0910-0457 submitted by the Center for Devices and
> Radiological Health. The burden increase of 2,000 hours, therefore is
> an adjustment.
>
> **16. [Plans of Tabulation and Publication and Project Time
> Schedule]{.underline}**
>
> The data will not be published in any formal manner. If a regulatory
> action is taken, based on the data collected, then this data will be
> cited in the action, if appropriate. For example, if a Public Health
> Advisory is issued, the information collected in the Rapid Response
> Survey may be cited.
>
> **17. [Reason Display of OMB Expiration Date is
> Inappropriate]{.underline}**
>
> The OMB number and expiration date will be listed on the standard
> survey form.
>
> **18. [Exemption to Certification for Paperwork Reduction Act
> Submissions]{.underline}**
>
> No exemptions requested.
>
> **B. [Collection of Information Employing Statistical
> Methods]{.underline}**

1.  **Potential Respondent Universe and Sample Selection Method**

> FDA will identify the respondent universe for each Rapid Response
> Survey. The appropriate respondent (i.e. typically risk managers, but
> occasionally nurses or physicians) for each survey will be determined
> by the medical product issue and the surveillance questions to be
> answered. However, to provide some general understanding of the size
> of potential universe samples, please see the example below:
>
> Number of risk managers belonging to the American Society for
> Healthcare Risk Management is approximately 3,600.
>
> Number of hospitals is approximately 6,000.
>
> FDA has available lists of professional organizations and medical
> institutions. These lists are kept up to date and used when the agency
> is sending out Safety Alerts and Public Health Advisories. These lists
> are one source of identifying potential respondents for these FDA
> Rapid Response Surveys. FDA also has excellent working relationships
> with professional organizations that have offered to assist us in
> identifying respondents for these data collection efforts. The
> American Society for Health and Risk Management is such an example.
>
> Additionally, as noted earlier, directed by the Food and Drug
> Administration Modernization Act of 1997, and in compliance with the
> Government Paperwork Elimination Act of 1998, FDA has developed a
> \"sentinel\" system to represent the various types of user facilities
> in the United States. Risk managers at different groups (hospitals,
> nursing homes, etc.) of these sentinel sites would function as the
> sample when appropriate, and would be contacted electronically.
>
> FDA proposes to draw a purposeful sample of respondents for each
> survey. Since the survey data will not be used for estimates of
> incidence, there is no need for a probability sample, and in fact, the
> selection of a probability sample would significantly delay the data
> collection effort, and increase the likelihood of more injuries
> occurring before FDA could take action. Finally, because the proposed
> data collection is qualitative, not quantitative, and because FDA
> resources for processing incoming data are limited, FDA proposes to
> try to keep each data collection effort to not more than 200
> respondents.
>
> A 70% response rate is expected. The impact of a lower response rate
> to any given questionnaire will be considered before FDA takes action
> to improve the response rate. FDA may determine that action is
> required based solely on only information from a few sources. The
> individuals analyzing the responses are clinical experts in the
> medical product under investigation. Therefore, if the response rate
> to a particular survey is low, but a problem pattern is noted in the
> obtained responses, FDA will act immediately without additional
> non-response follow-up. The goal of the information collection program
> \--i.e., to obtain data to perform a risk analysis and to provide the
> public with important information about possible hazards with medical
> products as soon as FDA becomes aware that such hazards exist \--
> could be met without additional follow-up.
>
> In other situations, a high non-response rate might prohibit FDA from
> determining whether a public health hazard exists. In these
> situations, FDA will do follow-up by mail (please see #3, below for
> details).
>
> **2. Information Collection Procedures**
>
> Once FDA identifies the need for additional surveillance data to
> address a potential public health hazard, the appropriate respondents
> will be identified either through FDA\'s lists or through the
> appropriate professional organizations. FDA's sentinel group will also
> be used as respondents.
>
> As described in #1, above, there is a need to require specialized
> sampling procedures. The reasons for purposeful sampling include:

-   the need to obtain targeted information from facilities or
    > professionals which have the most experience in the use of certain
    > medical products;

-   the data will not be used for estimates of incidents, so a
    > probability sample is not required, and may even be deleterious to
    > the timeliness of the process;

-   the proposed data collection is qualitative, not quantitative; and,

-   the limited resources available at FDA.

> FDA, therefore, proposes to draw a purposeful sample of respondents
> for each survey and the number of respondents will be selected based
> on the information needed, the type and availability of the
> appropriate respondent, and the potential seriousness of the issue.
> The number of respondents usually will not exceed 200 per survey.
>
> FDA will contact the facilities and health care professionals
> electronically, whenever possible, or by mail.
>
> Respondents will be asked to send in responses 30 days from the date
> of initiation of the survey. In the rare occasion when FDA requires
> immediate information, respondents will be asked to respond in a
> shorter time frame.
>
> When the surveys are returned, all facility identifiers will be
> removed (i.e. return envelopes destroyed; and respondents contacted
> electronically will be told not to respond electronically, but to send
> faxed responses - facility information will then be removed from faxed
> responses). The surveys will be processed and the data sent to the
> analysis team.
>
> Results will be characterized primarily using descriptive statistics
> since FDA generally lacks sufficient denominator information to do
> more sophisticated analysis. Again, the information collection is to
> obtain qualitative data not quantitative data. The data collected will
> be used to determine the risk to patient safety and to aid in
> developing appropriate FDA actions.
>
> [Degree of accuracy needed]{.underline}. The purpose of the emergency
> surveys is to collect information in an expeditious manner, which will
> help FDA to better understand a particular medical product problem to
> determine whether a public health issue is emerging. Whenever FDA has
> contacted health professionals who reported an adverse medical product
> event for more information, the individuals have been diligent in
> responding to FDA\'s questions and accuracy has not been a problem.
> Therefore, we fully anticipate that the health professionals contacted
> for each survey will respond with information that is as accurate as
> possible at the time of receiving the survey questions.
>
> If the need arises to perform long-term evaluations of a particular
> problem, FDA will come forward with research agendas to obtain more
> analytical information and will submit the proper request for a
> collection of information request to OMB as needed.
>
> **3. Methods to Maximize Response Rates**
>
> Every effort will be made to maximize response rates. In discussions
> with the American Society for Healthcare Risk Management, it was clear
> that respondents must feel confident there is no identifying
> information on the response forms, including any link to match the
> form with the name of an institution or individual on the sample list.
> Thus, to encourage maximum response rates, FDA will destroy any
> identifiers on response forms before giving the data to the analysis
> team.
>
> In situations where a high non-response rate might prohibit FDA from
> determining whether a public health hazard exists, FDA will do
> follow-up by mail. Three days after the requested date of response,
> FDA will issue a second letter to all respondents and will delineate
> further the need for those who have not responded to do so. All
> respondents must be contacted with this second letter since FDA will
> not know who has, and has not, already responded.
>
> If the second letter does not obtain increased participation, FDA will
> contact the professional association(s) representing the respondents
> and request that the association aids in the collection of the
> information. Respondents may be more comfortable sending the responses
> to their association rather than to a regulatory agency.
>
> **4. Test of Procedures**
>
> FDA has utilized this method of data collection for many years, on a
> much smaller scale. The scientists at FDA routinely contact the
> reporting facility to obtain additional information. While this
> answers specific questions related to a specific report, it is limited
> in scope. Often we need information from additional facilities. This
> information will be obtained through use of the FDA Rapid Response
> Surveys.
>
> The Consumer Product Safety Commission utilizes a survey method almost
> identical to the one described in this proposal with highly successful
> results.
>
> Further, we have presented the methodology described in this proposal
> to the association cited earlier (representative for risk managers) to
> obtain its input. The association agreed that the voluntary, anonymous
> approach described is the best means to obtain critical information in
> a timely manner.
>
> **5. Statistical Consultation and Independent Review**
>
> Information for this supporting statement and statistical plan came
> from the developer of the CDRH Rapid Response Survey Information
> Collection: OMB No. 0910-0457, which was used as the model.
>
> Brockton Hefflin, at (301) 594-0668, provided statistical consultation
> on the development of the original proposal.
>
> Depending on the issues under evaluation, to analyze the data the
> analysis teams will be set up in the Centers that are proposing to use
> this Rapid Response Survey mechanism.
>
> **Attachment A OMB Number 0910-0XXX**
>
> **Expiration Date: XX-XX-05.**
>
> **[RAPID RESPONSE SURVEY]{.underline}**
>
> Dear Colleague,
>
> The Food and Drug Administration (FDA) needs your help. This survey is
> designed to assist FDA in understanding more fully a potentially
> serious medical product problem.
>
> {SYNOPSIS OF PROBLEM GOES HERE}
>
> (You) (Your facility) (have been) (has been) selected for this survey
> because (you) (your facility) (are) (is) likely to have experience
> using this product.
>
> **Your participation in this survey is critical.** FDA believes there
> may be a potentially serious public health hazard and FDA must have
> additional information as quickly as possible. Because the number of
> respondents is small, each survey is vitally important in providing
> critical information.
>
> Your participation in this survey is voluntary and your responses are
> anonymous. There is no identifying information on the survey form;
> therefore, your responses to the survey questions cannot be linked to
> the respondent list. The survey sample list will be destroyed one
> month following the completion date of the survey.
>
> If you have any questions about this survey, please do not hesitate to
> call:
>
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
> at (301) \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ **Please do not
> identify yourself by name.**
>
> We are extremely appreciative of the time and effort involved in your
> participation in this important information collection. Your efforts
> will provide critical public health information.
>
> Please respond by: \_\_\_\_\_\_\_\_\_\_\_\_\_. Respondents are
> requested to route the survey questions and responses through the
> process improvement/quality improvement process in their facility to
> ensure the maximum input into this process.
>
> [Please feel free to respond by]{.underline}:
>
> *[Telephone]{.underline}*: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
> **Identify yourself as only "a respondent to the survey sent**
> \_\_\_\_\_\_\_\_\_\_ **date;**
>
> *[Fax]{.underline}: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_* **Do not send
> your institution's cover sheet. The Office Director's secretary will
> remove any identifiers your fax machine automatically assigns to the
> forms before giving the forms to the analysis team.**
>
> *[Mail]{.underline}:*
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Use the
> enclosed stamped, addressed return envelope for your convenience.
> **All return envelopes are addressed to the Office Director's
> secretary. Surveys will be removed and the envelope destroyed before
> the results are given to the analysis team.**
>
> **[Questions]{.underline}:**
>
> **A.**
>
> **B.**
>
> **C.**
>
> **D.**
>
> Page 2 -- Attachment A (Survey Form)
>
> Please fell free to provide any other information about this topic
> that you believe may be useful to FDA's analysis of the problem:
>
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> **Thank you for your time and energy in aiding FDA to understand more
> fully this issue!**
>
> Sincerely yours,
>
> John Q. Fed, Ph.D.
>
> Director, Office of Postmarketing Surveillance
>
> Center for XXXXX XXXXX xxx XXXXXXXXXX
>
> Food and Drug Administration
>
> Public reporting burden for this collection of information is
> estimated to average 30 minutes per response, including the time for
> reviewing instructions, searching data sources, gathering and
> maintaining the data needed, and completing/reviewing the collection
> of information. Send comments regarding this burden estimate or any
> other aspect of this collection of information, including suggestions
> for reducing this burden to:
>
> Director, Office of Postmarketing Surveillance
>
> HFX-XXX
>
> 5600 Fishers Lane
>
> Rockville, MD 20857
>
> An agency may not conduct or sponsor, and a person is not required to,
> a collection of information unless it displays a currently valid OMB
> control number. Form Approved: OMB Number 0910-0XXX, expires XX-XX-05.
>
> **Attachment B** **OMB No. 0910-0XXX**
>
> **Expiration Date: XX/XX/05**
>
> **[Rapid Response Survey]{.underline}**
>
> **Dear Colleague,**
>
> **The Food and Drug Administration needs your help.**
>
> **Your responses will help FDA understand if problems exist with
> respect to [\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.underline}.
> If problems do exist, your responses will help us understand the
> nature of those problems.**
>
> We appreciate your effort in supplying this information, as well as
> your prompt reply. For your convenience, a metered, envelope,
> addressed to the Society of Xxxxxxxx Xxxxxxxx, is supplied. Please
> respond no later than one week after receipt of this survey.
>
> {Supply reason why respondents have been selected for the survey.}
>
> Your participation in this survey is voluntary and your responses are
> anonymous. There is no identifying information on the survey form;
> therefore, your responses to the survey questions cannot be linked to
> the respondent list. The survey sample list will be destroyed one
> month following the completion date of survey. All responses will be
> sent to the Society of Xxxxxxxx Xxxxxxxx (XXX). XXX will destroy the
> envelopes and send only the anonymous responses to FDA. XXX will,
> however, keep track of respondents so that they can send a follow-up
> reminder to non-responders.
>
> If you have any questions about this survey, please do not hesitate to
> call:
>
> Xxxxxx Xxxxx of FDA at (301) XXX-XXXX, or
>
> Xxx Xxxxxx of XXX at (301) XXX-XXXX. **Please do not identify yourself
> by name.**
>
> We are extremely appreciative of the time and effort involved in your
> participation in this important information collection. Your efforts
> will provide critical public health information.
>
> Please feel free to respond using:
>
> *[Mail]{.underline}:* Use the enclosed stamped, addressed return
> envelope for your convenience. Note that all responses are sent to
> XXX. Your name and address are printed as the return address on the
> envelope. This is so that XXX may track the respondents. Only the
> anonymous survey forms will be forwarded to FDA.
>
> *[Fax]{.underline}:* You may fax your response to XXX at (301)
> XXX-XXXX. Please provide a cover sheet so that XXX may track the
> respondents.
>
> *[E-Mail]{.underline}:* If you wish to respond via e-mail, please
> contact Xxx Xxxxxx of XXX at <Xxxxxxx@XXX.com> to obtain an electronic
> copy of the survey. All identifying information will be deleted before
> responses are sent to FDA.
>
> **Attachment C OMB No. 0910-0XXX**
>
> **Expiration Date: XX/XX/05**
>
> **SAMPLE**
>
> **Heart Value Sizer Questionnaire**
>
> **Definitions:**
>
> "Manufacturer-supplied": sizers supplied by the valve manufacturer for
> use while selecting one of their valves.
>
> "Universal": sizers meant to be used with any manufacturer's valve.
>
> **Questions**

1.  Have you experienced problems during cardiac valve operations due to
    > sizer mismatching? (Please check all that apply.)

> Yes - Manufacturer-supplied
>
> Yes -- Universal
>
> No -- If no, proceed to questions number 4.
>
> If yes, please characterize the problems.
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

2.  If answer to (1) is yes, how long has it been since you experienced
    > problems with

```{=html}
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```
a)  Manufacturer-supplied sizers
    > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

b)  Universal sizers
    > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

```{=html}
<!-- -->
```
3.  If you answered yes to (1):

> What was the outcome?
>
> Replaced prosthesis with different size
>
> Replaced prosthesis with different manufacturer's device
>
> Modified the aortic root
>
> Other
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> At what stage of the valve operation did you detect the problem?
>
> Before suture placement in annulus
>
> Before suture placement in valve

4.  Do you have knowledge of this prosthetic sizer problem occurring
    > with other surgeons? (Please check all that apply.)

> Yes - Manufacturer-supplied
>
> Yes - Universal
>
> No
>
> If yes, how often does this seem to be occurring with other surgeons?
>
> Rarely
>
> Occasionally
>
> Frequently

5.  Have frustrations/difficulties with heart valve sizers been
    > expressed/discussed at clinical conferences/symposia?

> Yes, please describe
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> No

6.  If you could change heart valve sizing, would you choose to do so?

> No
>
> Yes
>
> If "yes", what would you suggest? (Please check all that apply.)
>
> Have universal sizer that measures patient's true annulus diameter
> \_\_\_\_\_.
>
> Standardizing size designation of all valves to the external suture
> cuff diameter \_\_\_\_\_.
>
> Standardizing size to prosthetic orifice diameter \_\_\_\_\_.
>
> Including both external cuff and orifice diameters is size
> description, e.g., as 21 mm
>
> (18 mm)\_\_\_\_\_.
>
> Providing a different designation scheme for unstented biological
> prostheses \_\_\_\_\_.
>
> > Other
> > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

7.  What kind of valves do you implant?

> Mechanical
>
> Stented biological
>
> Unstented biological

8.  How many valves do you replace per year? \_\_\_\_\_\_

> Please feel free to provide any other information about this topic you
> believe may be useful to FDA's analysis of the problem:
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> Thank you for your time and energy in aiding FDA to understand more
> fully this issue!
>
> Sincerely yours,
>
> Larry Kessler, Sc.D.
>
> Director, Office of Surveillance and Biometrics
>
> Center for Devices and Radiological Health
>
> Food and Drug Administration
>
> Public reporting burden for this collection of information is
> estimated to average 10 minutes per response, including the time for
> reviewing instructions, searching data sources, gathering and
> maintaining the data needed, and completing/reviewing the collection
> of information. Send comments regarding this burden estimate or any
> other aspect of this collection of information, including suggestions
> for reducing this burden to:
>
> Director, Office of Surveillance and Biometrics
>
> HFZ-500
>
> 1350 Piccard Drive
>
> Rockville, MD 20850
>
> An agency may not conduct or sponsor, and a person is not required to,
> a collection of information unless it displays a currently valid OMB
> control number.