SUPPORTING STATEMENT

**FOR**

**Medical Device Registration and Listing**

####### 21 CFR PARTS 807.22 & 807.31

**OMB No. 0910-0387**

**A. JUSTIFICATION**

The Food And Drug Administration (FDA) is requesting an extension of
approval of the information collection requirements in 21 CFR Parts
807.22 through 807.31 (Attachment A). This section describes the
procedures for domestic device establishments who must register and
submit a device list.

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

> Section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
> (Attachment B) requires that domestic establishments engaged in the
> manufacture, preparation, propagation, compounding, assembly, or
> processing of medical devices intended for human use and commercial
> distribution register their establishments and list the devices they
> manufacture with the Food and Drug Administration (FDA). This is
> accomplished by completing FDA Form 2891, "Initial Registration of
> Device Establishments" and FDA Form 2892 "Medical Device Listing."
> (Attachment 2) The term "device" is defined in section 201(h) of the
> FD&C Act and includes all in vitro diagnostic products and in vitro
> diagnostic biological products not subject to licensing under section
> 351 of the Public Health Service Act (42 U.S.C. 262). On August 14,
> 2001, all Hospitals who reprocess single-use devices will be required
> to register and list their activities. Under the FDA Modernization Act
> of 1997 (FDAMA) foreign manufacturers are now required to register
> their establishments and list their devices, but foreign registration
> and listing will be covered under a separate information requirement.
>
> The regulations for registration and listing are in 21 CFR Part 807
> (Attachment 3).

**[21 CFR 807.22(a) - REPORTING]{.underline}**

> Describes how and where to register establishments and list devices.
> This section explains that the establishment should first register on
> Form FDA-2891 (Initial Registration of Device Establishment) and
> subsequent annual registration shall be accomplished on form FDA-2891a
> (Annual Registration of Device Establishment). FDA will furnish Form
> 2891a to establishments whose registration for that year was validated
> under 21 CFR 807.35(a). The completed form shall be mailed to the FDA
> 30 days after receipt.
>
> **[21 CFR 807.22(b) - REPORTING]{.underline}**
>
> Specifies that the initial listing of devices and subsequent June and
> December updating shall be on form FDA-2892 (Medical Device Listing).
> Forms are obtainable upon request from FDA, and a separate form
> FDA-2892 shall be submitted for each device or device class listed
> with FDA. If variations in size, package shape, color, or composition
> exist, the device should be considered to be one device provided the
> variation does not change the function or intended use of the device.
> FDA also allows manufacturers to provide, in lieu of form FDA-2892,
> tapes for computer input or hard copy computer output, as long as all
> elements of information specified on form FDA-2892 are included. All
> alternatives to form FD-2892 require initial review and approval by
> FDA.
>
> **[21 CFR 807.31(e) - REPORTING]{.underline}**
>
> States that each owner or operator must be prepared to submit to FDA,
> upon specific request, copies of all labeling and advertising,
> statements of basis that the device is not a restricted device or a
> drug, and the name of distributors for whom a device has been
> manufactured under a label other than its own.
>
> **[21 CFR 807.31 - RECORDKEEPING]{.underline}**
>
> Requires each owner or operator to maintain an historical file
> containing the labeling and advertisements in use on the date of
> initial listing and in use after October 10, 1978, but before the date
> of initial listing. In addition, they shall maintain in the historical
> file any labeling or advertisements in which materials change has been
> made anytime after the initial listing. These files must be maintained
> for a period of 3 years after the date of the last shipment of a
> discontinued device by an owner or operator and made available when
> requested by FDA.

**2. [Purpose and Use of the Information]{.underline}**

> This information collection is necessary for the FDA to assure that
> devices are not adulterated or misbranded and are otherwise safe and
> effective for human use. The information will aid FDA in protecting
> the public from potentially hazardous devices, as well as devices with
> confirmed hazards. FDA analyzes the information as it is submitted,
> checking for problems in individual reports, and analyzing accumulated
> data to determine trends. Results of these analyses are utilized to
> determine if an FDA action is necessary, and if so, what action is
> appropriate.
>
> FDA is required to inspect manufacturers of certain medical devices to
> ensure that the devices are manufactured in accordance with good
> manufacturing practices. This information is used to identify
> geographic distribution in order to effectively allocate FDA field
> resources for these inspections and to identify the class of the
> device that determines the inspection frequency. In addition, when
> complications occur with a particular device or component,
> manufacturers of similar or related devices can easily be identified.
> If the firms did not submit this information, they would not be
> inspected regularly and defective devices could remain on the market,
> presenting potential life-threatening situations to the public.

**3. [Use of Information Technology and Burden Reduction]{.underline}**

> There are no technical or legal obstacles to the collection of this
> information.
>
> For the past two years, there has been a reengineering initiative
> underway to evaluate current program efficiency and provide
> recommendations on possible streamlining of the program. These
> initiatives include not only programmatic changes, but processing and
> data submission enhancements as well.
>
> There are numerous tasks that have been identified as a result of the
> reengineering process. One of the projects is the ability for industry
> to submit registration and listing data electronically via the
> Internet. The registration and listing process will be converted to a
> paperless process, both for initial and updated submissions, and will
> permit real‑time updates for the first time. FDA will also make nearly
> all registration and listing data available to the public via the
> Internet (the exception is the production status codes of listed
> devices). FDA will eliminate all paper forms (FDA forms 2891, 2891a,
> and 2892). Although some firms may not subscribe to an Internet
> service provider, we believe ready access is available through
> multiple channels: local libraries, FDA district offices, and
> commercial services such as Kinko's. Other federal agencies, notably
> the Securities and Exchange Commission, the Federal Communications
> Commission, and the Internal Revenue Service have already instituted
> electronic filing requirements that specifically exclude parallel
> paper submissions. The proposed regulation will solicit comments on
> the need for a "hardship exemption" for firms that do not have a
> personal computer capable of connecting to the Internet or the
> alternative FDA WWW server.
>
> FDA data files on registration and listing have been converted to
> online systems to reduce the processing burden and to provide
> information in a more timely manner. A new list of classification
> names and numbers for devices is available to those required to submit
> this information.

**4. [Efforts to Identify Duplication and Use of Similar
Information]{.underline}**

> The FDA is the only Federal agency responsible for the collection of
> such information, and the only agency charged with the responsibility
> of regulating medical devices and establishments. Therefore, no
> duplication of data exists.

**5. [Impact on Small Businesses or Other Small Entities]{.underline}**

> The requirements set forth in this regulation do not fall
> disproportionately upon small businesses. The threshold assessment
> conducted for this regulation shows that no more than 22 percent of
> the anticipated annual impact of these regulations should be
> attributed to small business establishments. The FDA continues to
> pursue ways and means of reducing the reporting burden for both small
> and large medical device manufacturers and will continue to employ the
> latest technology for receipt of reports, consistent with the intent
> of the regulation and protection of the public health.
>
> FDA aids small business in dealing with the requirements of the
> regulation by providing guidance and information through the Division
> of Small Manufacturers Assistance (DSMA), and through the Device
> Registration and Listing Branch within the Center for Devices and
> Radiological Health. DSMA provides workshops, on-site evaluations, and
> other technical and non-financial assistance to small manufacturers.
> The workshops make available publications and educational materials,
> which include medical device establishment and listing requirements.
> The Division also maintains a toll-free "800" telephone number which
> firms may use to obtain regulatory compliance information.
>
> These efforts help to assure that the burden on small manufacturers is
> minimized.

**6. [Consequences of Collecting the Information Less
Frequently]{.underline}**

> The Federal Food, Drug, and Cosmetic Act requires that a firm: (1)
> initially register once; (2) update the registration annually; (3)
> initially list a device when it is placed into commercial
> distribution; and (4) update the listing whenever there is a change or
> discontinued device. A less frequent collection of information would
> not be responsive to the requirements of the FD&C Act or provide
> current information relative to device manufacturers and the listing
> and/or discontinuance of various medical device products they market.

**7. [Special Circumstances Relating to the Guidelines of 5 CFR
1320.5]{.underline}**

> This information collection is consistent with the guidelines
> prescribed in 5 CFR 1320.5.

**8. [Comments in Response to the Federal Register Notice and Efforts to
Consult Outside Agency]{.underline}**

> In accordance with 5 CFR 1320.8(d), on July 6, 2001, in Volume 66, No.
> 130, page 35642, a 60-day notice for public comment (Attachment 4) was
> published in the Federal Register. No comments were received from the
> public.

FDA continually seeks input from industry representatives as well as
trade associations concerning registration and listing policies and
procedures. Over the last three years the Agency has had several open
forum Grassroots meetings with participation of FDA officials, industry
officials and health care professionals. These meetings were
specifically to discuss proposed reengineering activities and to solicit
input from these entities. The meetings were held in various locations
throughout the United States. Specifically: the West Coast on April 20
and 21, 1999; the East Coast on May 25; and the Mid-West on July 15,
1999.

**9. [Explanation of Any Payment or Gift to Respondents]{.underline}**

> No payment or gifts shall be proved to respondents under this
> regulation.

**10. [Assurance of Confidentiality Provided to
Respondent]{.underline}**

> Confidentiality of information submitted to FDA is governed by the
> provisions of 21 CFR 807.95. All registration and some listing data
> collected is available upon request under the Federal Freedom of
> Information Act, subject to FDA's implementing regulations, 21 CFR
> Part 20, Public Information. In addition, all information filed by a
> registrant is available for public inspection as required by 21 CFR
> 807.37.

**11. [Justification for Sensitive Questions]{.underline}**

> This information collection does not include questions pertaining to
> sexual behavior, attitude, religious
>
> beliefs, or any other matters that are commonly considered private or
> sensitive in nature.

**12. [Estimates of Hour Burden Including Annualized Hourly
Costs]{.underline}**

> The following is a summary of the estimated annual burden hours for
> medical device establishments to report in compliance with the
> provisions imposed by this regulation. For this year's submission we
> have broken out annual costs into two distinct phases.
>
> On August 14, 2001 hospitals who reprocess single-use devices will be
> required to register their establishments and list those device they
> reprocess. It is estimated that there will be approximately 2,000 such
> establishments that will fall into this category. The first year of
> the requirement will cause a one-time bolus of information to be
> submitted. We have separated the burden estimates into two tables to
> indicate Year One (Table 1A) and Subsequent Year's Estimates (Table
> 1B).

For the purposes of this submission, we would request that we be allowed
to use the Table 1a estimates since these figures are the most
conservative estimates.

> The annual reporting cost to respondents for registering
> establishments and listing devices is \$334,217. This figured was
> derived by multiplying the total reporting burden hours from Table 1B
> by an hourly rate of \$47. This hourly rate is based on a 2,080 annual
> work hours and at an annual salary rate of \$97,000. The salary rate
> includes salary, benefits, overhead, technical staff, support staff,
> etc. This annual rate was determined by the Agency's current estimates
> of staff expenses.
>
> FDA bases the estimates FY00 data from current systems and on
> conversations with industry and trade association representatives, and
> from internal review of the documents listed in the below table.

The estimate of burden for this collection of information is shown in
the following tables:

**Table 1A. \--Estimated [Year 1]{.underline} Annual Reporting Burden**

**FOR INFORMATION PURPOSES ONLY**

+---------+---------+---------+---------+---------+---------+---------+
| 21 CFR  | FDA     | Number  | Annual  | Total   | Hours   | Total   |
| Section | Form    | of      |         | Annual  | Per     | Hours   |
|         |         |         | Fr      |         |         |         |
|         |         | Resp    | equency | Re      | R       |         |
|         |         | ondents | of      | sponses | esponse |         |
|         |         |         |         |         |         |         |
|         |         |         | R       |         |         |         |
|         |         |         | esponse |         |         |         |
+---------+---------+---------+---------+---------+---------+---------+
| 80      | Form    | 2,045   | 1       | 2,045   | .25     | 511     |
| 7.22(a) | 2891    |         |         |         |         |         |
|         |         |         |         |         |         |         |
|         | Initial |         |         |         |         |         |
|         | Establ  |         |         |         |         |         |
|         | ishment |         |         |         |         |         |
|         | Regis   |         |         |         |         |         |
|         | tration |         |         |         |         |         |
+---------+---------+---------+---------+---------+---------+---------+
| 80      | Form    | 2,000   | 1       | 2,000   | .25     | 500     |
| 7.22(a) | 2891    |         |         |         |         |         |
|         |         |         |         |         |         |         |
| (See    | Initial |         |         |         |         |         |
| Note)   | Establ  |         |         |         |         |         |
|         | ishment |         |         |         |         |         |
|         | Regis   |         |         |         |         |         |
|         | tration |         |         |         |         |         |
+---------+---------+---------+---------+---------+---------+---------+
| 80      | Form    | 3,450   | 1       | 3,450   | .50     | 1,725   |
| 7.22(b) | 2892    |         |         |         |         |         |
|         | Device  |         |         |         |         |         |
|         | Listing |         |         |         |         |         |
|         | --      |         |         |         |         |         |
|         | initial |         |         |         |         |         |
|         | and     |         |         |         |         |         |
|         | updates |         |         |         |         |         |
+---------+---------+---------+---------+---------+---------+---------+
| 80      | Form    | 2,000   | 10      | 20,000  | .50     | 10,000  |
| 7.22(b) | 2892    |         |         |         |         |         |
|         | Device  |         |         |         |         |         |
| (See    | Listing |         |         |         |         |         |
| Note)   | --      |         |         |         |         |         |
|         | initial |         |         |         |         |         |
|         | and     |         |         |         |         |         |
|         | updates |         |         |         |         |         |
+---------+---------+---------+---------+---------+---------+---------+
| 80      | Form    | 16,500  | 1       | 16,500  | .25     | 4,125   |
| 7.22(a) | 2891    |         |         |         |         |         |
|         | (a) --  |         |         |         |         |         |
|         | Regis   |         |         |         |         |         |
|         | tration |         |         |         |         |         |
|         | Update  |         |         |         |         |         |
+---------+---------+---------+---------+---------+---------+---------+
| 80      |         | 200     | 1       | 200     | .50     | 100     |
| 7.31(e) |         |         |         |         |         |         |
+---------+---------+---------+---------+---------+---------+---------+
| Total   |         |         |         |         |         | 16,961  |
| Year 1  |         |         |         |         |         |         |
|         |         |         |         |         |         |         |
| Burden  |         |         |         |         |         |         |
| Hours   |         |         |         |         |         |         |
+---------+---------+---------+---------+---------+---------+---------+

There are no capital costs or operating and maintenance costs associated
with this collection of information.

**Table 1B. \--Estimated Subsequent Years Annual Reporting Burden**

+---------+---------+---------+---------+---------+---------+---------+
| 21 CFR  | FDA     | Number  | Annual  | Total   | Hours   | Total   |
| Section | Form    | of      |         | Annual  | Per     | Hours   |
|         |         |         | Fr      |         |         |         |
|         |         | Resp    | equency | Re      | R       |         |
|         |         | ondents | of      | sponses | esponse |         |
|         |         |         |         |         |         |         |
|         |         |         | R       |         |         |         |
|         |         |         | esponse |         |         |         |
+---------+---------+---------+---------+---------+---------+---------+
| 80      | Form    | 2,245   | 1       | 2,245   | .25     | 561     |
| 7.22(a) | 2891    |         |         |         |         |         |
|         |         |         |         |         |         |         |
|         | Initial |         |         |         |         |         |
|         | Establ  |         |         |         |         |         |
|         | ishment |         |         |         |         |         |
|         | Regis   |         |         |         |         |         |
|         | tration |         |         |         |         |         |
+---------+---------+---------+---------+---------+---------+---------+
| 80      | Form    | 3,650   | 1       | 3,650   | .50     | 1,825   |
| 7.22(b) | 2892    |         |         |         |         |         |
|         | Device  |         |         |         |         |         |
|         | Listing |         |         |         |         |         |
|         | --      |         |         |         |         |         |
|         | initial |         |         |         |         |         |
|         | and     |         |         |         |         |         |
|         | updates |         |         |         |         |         |
+---------+---------+---------+---------+---------+---------+---------+
| 80      | Form    | 18,500  | 1       | 18,500  | .25     | 4,625   |
| 7.22(a) | 2891    |         |         |         |         |         |
|         | (a) --  |         |         |         |         |         |
|         | Regis   |         |         |         |         |         |
|         | tration |         |         |         |         |         |
|         | Update  |         |         |         |         |         |
+---------+---------+---------+---------+---------+---------+---------+
| 80      |         | 200     | 1       | 200     | .50     | 100     |
| 7.31(e) |         |         |         |         |         |         |
+---------+---------+---------+---------+---------+---------+---------+
| Total   |         |         |         |         |         | 7,111   |
| Year    |         |         |         |         |         |         |
| 2&3     |         |         |         |         |         |         |
|         |         |         |         |         |         |         |
| Burden  |         |         |         |         |         |         |
| Hours   |         |         |         |         |         |         |
+---------+---------+---------+---------+---------+---------+---------+

There are no capital costs or operating and maintenance costs associated
with this collection of information.

####### 

####### Using FY00 data, FDA estimates that recordkeeping (Table 2 below) costs for respondents is \$1,336,500. This figure was determined by multiplying the total number of hours estimated for recordkeeping (49,500) by \$27. Historical submissions, trend analysis and estimates for annual cost of living increases at 3% determined the hourly rate.

####### 

####### Table 2 -- Estimated Annual Recordkeeping Burden

  ----------- --------------- -------------- ----------- -------------- -----------
  21 CFR      Number of       Annual         Total       Hours per      Total Hours
  Section     Recordkeepers   Frequency per  Annual      Recordkeeper   
                              Recordkeeper   Records                    

  807.31      9,900           10             99,000      .50            49,500

  Total                                                                 49,500
  Burden                                                                
  Hours                                                                 
  ----------- --------------- -------------- ----------- -------------- -----------

**13. [Estimate of Other Total Annual Cost Burden to Respondents or
Recordkeepers]{.underline}**

> There are no additional costs associated with this information
> collection.

**14. [Annualized Cost to the Federal Government]{.underline}**

> FDA anticipates that the federal government will incur the following
> costs:

**[Staff Costs]{.underline}**

Total annual cost to the Federal Government = \$1,460,000

Full time Equivalents = 8

Annual Cost per FTE=\$97,000

Annual Cost = \$776,000

Contract Costs = \$684,000 - We currently pay for the services of an 8A
contractor to process all registration and listing submissions.

**15. [Explanation for Program Changes or Adjustments]{.underline}**

The explanation for adjustments from the previous approval is:

-   The number of respondents has changed. We report numbers based on
    the current findings from our automated database which provides us
    with submission numbers and rates. Based on FY00 data, the number of
    [active]{.underline} registered establishments has decreased. The
    explanation for decrease is threefold: 1) we've recently done a
    clean-up of the data base and have eliminated some duplications; 2)
    the previous submission included numbers for foreign establishments,
    in error; and 3) as a result of FDAMA, domestic distributors are no
    longer required to register and list.

```{=html}
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-   Although the burden rate has decreased due to the above
    circumstance, one other change in the program has occurred since the
    last approval. On August 14, 2001, hospitals who reprocess
    single-use devices will be required to register their establishments
    and list those devices they reprocess. It is estimated that there
    will be approximately 2,000 such establishments that will fall into
    this category. The bolus of information submitted from these two
    responders will be in the first year of the requirement and this
    approval. Subsequent year's adjustments will be minimal due to the
    unlikelyhood of a significant increase in the establishment of new
    hospitals who reprocess medical devices. We did include an increase
    over the previously approved reporting burden to account for any
    increases due to reprocessing of medical devices.

-   Based on the information listed above, FDA did experience a net
    increase of 18,175 respondent burden hours for this collection.

**16. [Plans for Tabulation and Publication and Project Time
Schedule]{.underline}**

> FDA does not intend to publish the results of this information
> collection.

**17. [Reason(s) Display of OMB Expiration Date is
Inappropriate]{.underline}**

> Currently, CDRH is not requesting an exemption for display of the OMB
> expiration date.

**18. [Exception to Certification for Paperwork Reduction Act
Submissions]{.underline}**

> Currently, CDRH is not requesting an exemption to Certification for
> the Paperwork Reduction Act Submissions.

**19. [Certification for Paperwork Reduction Act
Submissions]{.underline}**

No exceptions have been identified.

**B. [Collection of Information Employing Statistical
Methods]{.underline}**

> There are no statistical methods being employed in this collection of
> information.

**[List of Attachments to Supporting Statement:]{.underline}**

Attachment 1 - Code of Federal Regulations (21 CFR 807, Subpart B, Parts
807.20 through 807.39)

Attachment 2 - Federal Food, Drug, and Cosmetic Act, Section 510

Attachment 3 - Medical Device Registration and Listing Forms FDA 2891,
2891a, and 2892

Attachment 4 - July 6, 2001 Federal Register 60 day Notice (Volume 66,
No. 130, page 35642) Soliciting Comments on FDA Medical Devices
Registration and Listing