0910-0114 ss 12 22 2009

Supporting Statement – OMB No. 0910-0114

Administrative Detention and Banned Medical Devices

21 CFR 800.55(g)(1) & (2), 800.55(k), and 895.22

Supporting Statement

0910-0114

A. JUSTIFICATION

1. Circumstances Making the Collection of Information Necessary

Abstract

The Food and Drug Administration (FDA) has the statutory authority under section 304(g) of the Federal Food, Drug and Cosmetic Act [21 U.S.C. 334(g)] (the Act), where officers or employees duly designated by the Secretary (FDA investigators) may detain devices during establishment inspections which are believed to be adulterated or misbranded. http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChapterIIIProhibitedActsandPenalties/ucm106918.htm

On March 9, 1979, FDA issued, under 21 CFR 800.55, a final regulation on Administrative Detention Procedures (44 FR 13234), under section 304(g) of the Act, which includes certain reporting requirements [800.55(g)(l) & (2)] and recordkeeping requirements (800.55(k)]. Under § 800.55(g), an appellant of a detention order must show documentation of ownership if devices are detained at a place other than that of the appellant. Under § 800.55(k), the owner or other responsible person must supply records about how the devices may have become adulterated or misbranded, as well as records of distribution of the detained devices. These recordkeeping requirements for administrative detentions allow FDA to trace devices for which the detention period expired before a seizure is accomplished or injunctive relief is obtained.

FDA also has the statutory authority under section 516 of the Act [21 U.S.C. 360f] to ban devices that present substantial deception, or unreasonable and substantial risk of illness or injury, or unreasonable, direct, and substantial danger to the health of individuals. The final regulation for Banned Devices (44 FR 29221), which issued on May 18, 1979, (21 CFR Part 895), contained certain reporting requirements, 21 CFR 895.21(d) and 895.22(a).

This information collection is not related to the American Recovery and Reinvestment At of 2009 (ARRA).

FDA is requesting approval from the Office of Management and Budget (OMB) for the following requirements:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPartFrom=800&CFRPartTo=1299

Reporting

21 CFR 800.55(g)(1) and (2) - Administrative Detention Reporting

A person who would be entitled to claim the devices, if seized may appeal a detention order by submitting a written request to the FDA District director in whose district the devices are located. This written appeal could include a request for an informal hearing as defined in section 201(y) of the Act. In some cases, the appellant must include documents showing that that person has the legal right to appeal this order.

21 CFR 800.55(h)(2) – Movement of Detained Devices

If detained devices are not in final form for shipment, the manufacturer may move them within the establishment where they are detained to complete the work needed to put them in final form. As soon as the devices are moved for this purpose, the individual responsible for their movement shall orally notify the FDA representative who issued the detention order, or another responsible district office official, of the movement of the devices. As soon as the devices are put in final form, they shall be segregated from other devices, and the individual responsible for their movement shall orally notify the FDA representative who issued the detention order, or another responsible district office official, of their new location. The devices put in final form shall not be moved further without FDA approval.

21 CFR 895.21(d)(8) – Procedures for Banned Devices Informal Hearing Request

Under § 895.21(d), the Commissioner may decide to initiate a proceeding to make a device a banned device. In that event, any interested persons may submit written comments and request an informal hearing within 30 days after the date of the publication of the proposed regulation.

21 CFR 895.22(a) - Banned Devices Reporting

A manufacturer, distributor, or importer of a device may be required to submit to the FDA all relevant and available data and information to enable the Commissioner to determine whether the device presents substantial deception, unreasonable, direct, and substantial danger to the health of individuals.

Recordkeeping

21 CFR 800.55(k) - Administrative Detention Recordkeeping

The firm shall have, or establish, and maintain records relating to how the detained devices may have become adulterated or misbranded, records on any distribution of the devices before and after the detention period, records on the correlation of any in-process detained devices that are put in final form, records of any changes in, or process of, the devices permitted under the detention order, and records of any movement of the detained devices.

2. Purpose and Use of the Information Collection

Data and information collected under the reporting and recordkeeping requirements of the administrative detention and banned device regulations are used by the Agency to determine if the devices which are believed to be adulterated and/or misbranded; present substantial deception, unreasonable and substantial risk of illness or injury, or unreasonable, direct, and substantial danger to the health of individuals are removed from the marketplace. If the FDA did not have these regulations, it would not have access to certain types of data and information which industry possesses. Thus, the collection of this information enables the Agency to perform its mission of consumer protection.

When a detention order is put into place, the Agency must know if any other devices which would be subject to the order, were distributed prior to that time to assure that those devices are removed from the marketplace and do not cause any adverse effects. The recordkeeping requirement of the Administrative Detention regulation gives FDA the authority to obtain distribution information which the Agency might not otherwise have. This recordkeeping requirement may also provide FDA with an answer for how the devices became adulterated and/or misbranded.

FDA has only used the Banned Device regulation once to require importers of prosthetic hair fibers to supply the Agency with data and information relating to this product. Information obtained under the reporting requirements of this regulation, which would not otherwise be available to the Agency, convinced FDA that this device should be banned from commercial distribution. FDA may use this regulation in the future in regards to another device if the Commissioner believes that more information is necessary for the Agency to determine whether the device presents a substantial deception, an unreasonable and substantial risk of illness or injury, or unreasonable, direct and substantial danger to the health of individuals. The FDA would then require that the manufacturer, distributor, or importer submit all relevant and available data and information. After consulting with the appropriate classification panel, FDA may initiate a proceeding to ban the device by publishing a proposed regulation in the FEDERAL REGISTER. After affording all interested persons an opportunity for an informal hearing on the proposal, FDA will affirm, modify, or revoke the proposed regulation. If the proposal is affirmed or modified, the Agency will publish a final regulation banning the device.

Responders to this information collection consist of private sector for-profit businesses

3. Use of Improved Information Technology and Burden Reduction

The Code of Federal Regulation (CFR), (21 CFR Part 11) permits, under certain circumstances, the agency to accept electronic signatures and handwritten signatures executed to electronic records as generally equivalent to paper records and handwritten signatures executed on paper. These regulations would apply to records, submitted in electronic form, that are required in Title 21 of the CFR. The use of electronic forms for record keeping and reporting submissions to FDA remains voluntary. The intended effect of this regulation is to permit use of electronic technologies in a manner that is consistent with FDA's overall mission and that preserves the integrity of the agency's enforcement activities.

Some firms use computers to store information under the recordkeeping requirements of these regulations, which has led to a decrease of industry’s time. CAD-CAM (Computer Assisted Drawing - Computer Assisted Manufacturing), lasers, photo-etching, etc., are also used to assist manufacturers in making changes to the devices, or device labeling. This results in compliance with this regulation and eliminates the need to ban a device.

It is estimated that 98% of respondents use electronic means to fulfill the Agency’s requirement or request.

4. Efforts to Identify Duplication and Use of Similar Information

FDA is the only federal agency responsible for regulating medical devices. As such, there is no duplication of effort or requirements.

5. Impact on Small Businesses or Other Small Entities

It is estimated that there is only one respondent on occasion from for-profit businesses.

These regulations apply equally to all firms, regardless of the size of the establishment, if the product in question is believed to be adulterated or misbranded, in the case of administrative detentions, or presents an unreasonable risk or deception to the public, in the case of banning a device. FDA also offers the resources of the Center for Devices and Radiological Health’s (CDRH) Division of Small Manufacturers, International and Consumer Assistance (DSMICA) and the Office of Device Evaluation (ODE) staffs. DSMICA’s staff provides technical and other nonfinancial assistance to small firms expressly to aid them in complying with the requirements of the Act. The activities of DSMICA include participating in and presenting conferences, workshops, seminars on the application and interpretation of relevant regulations, consulting with individual firms/sponsors, and development and dissemination of educational materials. Staff is available to respond to questions and a toll free telephone number was established to facilitate this communication link

6. Consequences of Collecting the Information Less Frequently

It is estimated that one respondent will report on occasion. The collection of data and information under these regulations is conducted on a very infrequent basis and only as necessary. Thus, FDA could not adequately protect the public health if this information were conducted less frequently.

There are no legal obstacles to reduce the burden.

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

There are no special circumstances for this collection of information.

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside Agency

In accordance with 5 CFR 1320.8(d), FDA published a 60 day notice for public comment in the FEDERAL REGISTER of 10/16/2009 (74 FR 53257). No comments were received.

http://edocket.access.gpo.gov/2009/pdf/E9-24921.pdf

FDA’s experience with the administrative detention reporting and recordkeeping requirements has shown that most establishments maintain records required by good manufacturing practice regulations. A review of all forty-nine (49) administrative detentions that have been enforced in approximately twenty-two years prior to this reporting period indicates that this regulation has not been an unreasonable burden on industry. In most cases, the devices were either seized or voluntarily corrected (reconditioned, relabeled, or destroyed) within the period of detention or shortly thereafter.

The last administrative detention that was conducted was in 2002 with a firm that manufactured OB/GYN devices that were labeled sterile but had never been sterilized. The firm fled the U.S. and therefore we can not ascertain any estimated reporting burden. In the previous approval for this information collection, FDA spoke with Dr. Nadeem M. Muna, President, Immuno Diagnostic Products, Inc. (North Salt Lake City, Utah, (801) 298-7535), regarding the administrative detention of immunofluorescent test kits. This is the last administrative detention that FDA has taken in which we received comments from outside the Agency.

FDA has limited experience with the regulations for Banned Devices in that it was only used once to ban prosthetic hair fibers (49 FR 1177). FDA has not solicited any further comment from outside of the Agency regarding banning actions and will depend on input received from the 60-day Federal Register Notice for comment.

9. Explanation of Any Payment or Gift to Respondents

FDA will not provide any payments or gifts to respondents of this information collection.

10. Assurance of Confidentiality Provided to Respondent

Information provided to, or obtained by, FDA is subject to release under the Freedom of Information Act (5 U.S.C. 552) and the implementing regulations contained in 21 CFR Parts 20 and 21.

11. Justification for Sensitive Questions

The information required in this information collection does not include questions about sexual behavior, attitude, religious beliefs, or any other matters which are commonly considered private or sensitive in nature.

12. Estimates of Hour Burden Including Annualized Hourly Costs

12a. Annualized Hour Burden Estimate

FDA estimates the burden of this collection of information as follows:

Table 1.--Estimated Annual Reporting Burden¹

21 CFR Part	No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Response	Total Hours
800.55(g)	1	1	1	25	25
895.21(d)(8) and 895.22(a)	26	1	26	16	416
TOTALS					441

¹There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 2.--Estimated Annual Recordkeeping Burden¹

21 CFR Part	No. of Recordkeepers	Annual Frequency per Recordkeeping	Total Annual Records	Hours per Recordkeeper	Total Hours
800.55(k)	1	1	1	20	20
TOTALS					461

¹There are no capital costs or operating and maintenance costs associated with this collection of information.

Only one administrative detention action has been taken over the past 15 years. Each administrative detention will have varying amounts of data and information that must be maintained. FDA's estimate of the burden under the administrative detention provision is based on FDA's discussion with the last firm whose devices had been detained. Historically, FDA has had very few or no annual responses for this information collection.

This regulation also refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR 10.30 have been approved under OMB control number 0910-0183 and the collections of information in 21 CFR 801 have been approved under 0910-0485.

12b. Annualized cost Burden Estimate

FDA estimated the total cost for this program by checking industry wage rates reported on Salary.com for Regulatory Affairs Professionals as of November 13, 2009. The estimated range of average salary including bonuses and benefits for regulatory affairs professionals is $109,050 to $158,000 per year, or $52 to $76 per hour. Based on FDA’s history with administrative detentions over the past three years, FDA believes that the total estimated reporting and recordkeeping burden cost to industry for this information collection will be $4,160, which is the total number of hours expended (80) multiplied by the Salary.com low-end average wage rate of $52 per hour.

In a previous reporting period, a large firm (Life Design Systems) reported that they spent approximately $4,000.00 in recordkeeping re: reconditioning/testing or destruction of product. However, it should be noted that this product was seized and that reconditioning and destruction did not start until after a Consent Decree was entered into. Thus, the firm would have spent $4,000.00 on recordkeeping even if the product was not administratively detained. The estimated cost for a respondent to have a hearing to appeal an administrative detention could be several thousand dollars or more, depending upon whether an attorney is involved and the documented evidence. Life Design Systems decided to appeal the administrative detention, hired a well-known law firm, hired a research firm to find case law, paid the court reporter for the transcripts, had several of their people on hand during a rather lengthy hearing, and reported that they spent over $80,000.00 on the appeal.

13. Estimate of Other Total Annual Cost Burden to Respondents or Recordkeepers

There are no capital costs and or operating and maintenance costs for this information collection.

14. Annualized Cost to the Federal Government

The annualized cost to the Federal Government, which is based upon approximately 0.1 staff years at $120,000 per year, amounts to approximately $12,000. Additional costs will be incurred if the administrative detention is appealed and a hearing is conducted to determine if the Agency had cause to take such an action. This hearing must be conducted in accordance with 21 CFR 800.55(g)(3) and has the potential of costing the Agency thousands of dollars. The cost to the Federal Government for one appeal hearing, which is based upon the staff hours necessary to review and prepare for a hearing, plus the cost of transporting General Counsel Attorneys to the district office where the devices were detained, is approximately $10,000. This figure was derived by multiplying an average hourly attorney rate ($56) by 160 hours, plus $2,500 for transportation fees.

During the approximately 30 years that the banned device regulation has been in effect, FDA has only used it once to ban prosthetic hair fibers (21 CFR 895.101.) Therefore, the annual cost to the government is $24,500 ($10,000+12,000+2,500).

15. Explanation for Program Changes or Adjustments

There is a slight change adding 2 more respondents and 1 more burden hour due to re-estimating and rounding up.

16. Plans for Tabulation and Publication and Project Time Schedule

The collection of information under these regulations will not be published for statistical use.

17. Reason(s) Display of OMB Expiration Date is Inappropriate

FDA is not seeking an exemption from the requirement to display the effective date.

18. Exception to Certification for Paperwork Reduction Act Submissions

The requirements of the administrative detention and banned device regulations are consistent with 5 CFR 1320.9. There are no exceptions to the certification statement in item 19 of OMB Form 83-I.

19. Certification for Paperwork Reduction Act Submissions

B. Collection of Information Employing Statistical Methods

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

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