[Federal Register Volume 66, Number 95 (Wednesday, May 16, 2001)]
[Notices]
[Pages 27147-27149]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-12277]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0050]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Premarket Approval of Medical Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Submit written comments on the collection of information by June 
15, 2001.

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

FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION:

I. Background

    In compliance with 44 U.S.C. 3507, FDA has submitted the following 
proposed collection of information to OMB for review and clearance.

Premarket Approval of Medical Devices--21 CFR Part 814 (OMB Control 
No. 0910-0231)--Extension

    Section 515 of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 360(e)) sets forth the requirements for premarket approval 
of certain class III medical devices. Class III devices are either 
preamendments devices that have been classified into class III, 
postamendments devices that are not substantially equivalent to a 
preamendments device, or transitional devices. Class III devices are 
devices such as implants, life sustaining or life supporting devices, 
or devices which otherwise present a potentially unreasonable risk of 
illness or injury, or for which are of substantial importance in 
preventing impairment of human health. Most premarket approval 
applications (PMAs) are for postamendments class III devices.
    Under section 515 of the act, an application must contain several 
pieces of information including full reports of all information 
concerning investigations showing whether the device is reasonably safe 
and effective. The application should also include a statement of 
components, ingredients, and properties and of the principle or 
principles of operation of such a device and should also include a full 
description of the methods used in, and the facilities and controls 
used for the manufacture and processing of the device; and labeling 
specimens.
    The implementing regulations, contained in part 814 (21 CFR part 
814), further specify the contents of a PMA for a class III medical 
device and the criteria FDA employs in approving, denying, or 
withdrawing approval of a PMA and supplements to PMAs. The regulation's 
purpose is to establish an efficient and thorough procedure for FDA's 
review of PMAs and supplements to PMAs for certain class III (premarket 
approval) medical devices. The regulations contained in part 814 
facilitate the approval of PMAs and supplements to PMAs for devices 
that have been shown to be reasonably safe and effective and otherwise 
meet the statutory criteria for approval. The regulations also ensure 
the disapproval of PMAs and supplements to PMAs for devices that have 
not been shown to be reasonably safe and effective and that do not 
otherwise meet the statutory criteria for approval.
    The Food and Drug Modernization Act of 1997 (FDAMA) (Public Law 
105-115) was enacted on November 21, 1997, to implement revisions to 
the act by streamlining the process of bringing safe and effective 
drugs, medical devices, and other therapies to the U.S. market. Several 
provisions of this act affect the PMA process, such as section 
515(d)(6) of the act. This section provided that PMA supplements were 
required for all device changes that affect safety and effectiveness of 
a device unless such changes are modifications to manufacturing 
procedures or method of manufacture. This type of manufacturing change 
requires a 30-day notice, or where FDA finds such notice inadequate, a 
135-day PMA supplement.
    To make the PMA process more efficient, FDA has in the past 3 years 
made changes to the PMA program based on comments received, has 
complied with changes to the program mandated by FDAMA and has worked 
towards completion of its PMA reinvention efforts.
    Respondents to this information collection are persons filing a PMA 
application or a PMA supplement with FDA for approval of certain class 
III medical devices. Part 814 defines a person as any individual, 
partnership, corporation, association, scientific or academic 
establishment, government agency or organizational unit, or other legal 
entity. These respondents include entities meeting the definition of 
manufacturers such as manufacturers of commercial medical devices in 
distribution prior to May 28, 1976 (the enactment date of the Medical 
Device Amendments). Additionally, hospitals that reuse single use 
devices (SUDs) are

[[Page 27148]]

also included in the definition of manufacturers. For the next 3 years, 
it is expected that FDA will receive four PMA applications from 
hospitals that remanufacture SUDs. This figure has been included in 
table 1 of this document as part of the reporting burden in 
Sec. 814.15.
    In the Federal Register of February 8, 2001 (66 FR 9582), the 
agency requested comments on the proposed collection of information. No 
comments were received.
    The total estimated reporting and recordkeeping burden for this 
information collection is 107,321 hours. FDA estimates the burden of 
this collection of information as follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                      Annual rrequency per     Total annual
21 CFR section  No. of respondents          response             responses    Hours per response    Total hours
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814.15,                62                                 1        62               837            51,894
 814.20, and
 814.37
814.39(f)             487                                 1       487                66            32,142
814.82                 43                                 1        43                66             5,805
814.84                 43                                 1        43                10               430
Section 201            10                                 1        10                10               100
 (FDAMA)
Section 202            15                                 1        15                10               150
 (FDAMA)
Section 205             8                                 1         8                50               400
 (FDAMA)
Section 208            26                                 1        26                30               780
 (FDAMA)
Section 209             8                                 1         8                40               320
 (FDAMA)
                                                                                                 ---------------
Total                                                                                              92,021
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
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                                                                         Annual frequency per       Total annual        Hours per
               21 CFR section                  No. of recordkeepers          recordkeeping             records         recordkeeper       Total hours
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          814.82(a)(5) and (a)(6)                                900                         1                 900               17              15,300
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    The industry-wide burden estimate for PMAs is based on an FDA 
actual average fiscal year annual rate of receipt of 62 PMA original 
applications and 487 PMA supplements, using fiscal year 1996 through 
2000 data.
    The burden data for PMAs is based on data provided by manufacturers 
by device type and cost element in an earlier study. The specific 
burden elements for which FDA has data are as follows: (1) Clinical 
investigations: 67 percent of total burden estimate; (2) submission of 
additional data or information to FDA during a PMA review: 12 percent; 
(3) additional device development cost (e.g., testing): 10 percent; and 
(4) PMA and PMA supplement preparation and submissions, and development 
of manufacturing and controls data: 11 percent.

II. Paperwork Burden Estimate

    The burden estimates were derived by consultation with FDA and 
industry personnel. FDA's estimates are based on actual data collected 
from industry over the past 3 years. An evaluation of the type and 
scope of information requested was also used to derive some time 
estimates. For example, disclosure information primarily requires time 
only to update and maintain existing manuals.

A. Reporting/Disclosure

    The reporting burden can be broken out by certain sections of the 
PMA regulation: (1) Sec. 814.15 Research conducted outside the United 
States; (2) Sec. 814.20 Application; and (3) Sec. 814.37 PMA amendments 
and resubmitted PMA's.
    The majority of the burden--51,894 burden hours--is due to the 
above three requirements. Included in these three requirements are the 
conduct of laboratory and clinical trials as well as the analysis, 
review, and physical preparation of the PMA application. FDA estimates 
that 62 manufacturers (including hospital remanufacturers of single use 
devices) will be affected by these requirements based on actual average 
FDA receipt of new PMA applications in years 1996 through 2000. FDA's 
estimate of the hours per response (837) was derived through FDA's 
experience and consultation with industry and trade associations. 
Included in these three requirements are the conduct of laboratory and 
clinical trails as well as the analysis, review, and physical 
preparation of the PMA application. In addition, FDA has based its 
estimate on the results of an earlier study that these requirements 
account for the bulk of the burden identified by manufacturers.
1. Sec. 814.39(f)--PMA Supplements: 32,142 Burden Hours
    FDA believes that the amendments mandated by FDAMA for 
Sec. 814.39(f), permitting the submission of the 30-day notices in lieu 
of regular PMA supplements, will result in an approximate 10 percent 
reduction in the total number of hours as compared to regular PMA 
supplements. As a result, FDA estimates that 32,142 hours of burden are 
needed to complete the requirements for regular PMA supplements.
2. Sec. 814.82--Postapproval requirements: 5,805 Burden Hours
    Postapproval requirements concern approved PMAs that were not 
reclassified and require a periodic report. In the last decade (1991 to 
2000), the range of PMAs that fit this category averaged approximately 
43 per year (70 percent of the 62 periodic submissions). Most approved 
PMAs have been subject to some postapproval study requirement. 
Approximately half of the average submitted PMAs (31) require 
associated postapproval studies (i.e., followup of patients used in 
clinical trials to support the PMA or additional preclinical 
information) that is labor-intensive to compile and complete, and the 
other PMAs require minimal information. Based on its experience

[[Page 27149]]

and on consultation with industry, FDA estimates that preparation of 
reports and information required by this section require 5,805 hours 
(135 hours per respondent).
3. Sec. 814.84--Reports: 430 Burden Hours
    Postapproval requirements described in Sec. 814.82 (above) require 
a periodic report. FDA has determined respondents meeting the criteria 
of Sec. 814.84 will submit reports on a periodic basis. As stated 
previously, the range of PMAs fitting this category averaged 
approximately 43 per year. These reports have minimal information 
requirements. FDA estimates that respondents will construct their 
report and meet their requirements in approximately 10 hours. This 
estimate is based on FDA's experience and on consultation with 
industry. FDA estimates that the periodic reporting required by this 
section take 430 hours.
    The total hours for statutory burden is 1,750. This burden estimate 
was based on actual real FDA data tracked from January 1, 1998, to the 
present, and an estimate was derived to forecast future expectations 
with regard to this statutory data.

B. Recordkeeping

    The recordkeeping burden in this section involves the maintenance 
of records used to trace patients and the organization and indexing of 
records into identifiable files to ensure the device's continued safety 
and effectiveness. These records would be required only of those 
manufacturers who have an approved PMA and who had original clinical 
research in support of that PMA. For a typical year's submissions, 70 
percent of the PMAs are eventually approved and 75 percent of those 
have original clinical trial data. Therefore, approximately 43 PMAs a 
year (62 annual submissions times 70 percent) would be subject to these 
requirements. Also, because the requirements apply to all active PMAs, 
all holders of active PMA applications must maintain these records. 
PMAs have been required since 1976, and there are 900 active PMAs that 
could be subject to these requirements, based on actual FDA data. Each 
study has approximately 200 subjects, and, at an average of 5 minutes 
per subject, there is a total burden per study of 1,000 minutes, or 17 
hours. The aggregate burden for all 900 holders of approved original 
PMAs, therefore, is 15,300 hours (900 approved PMAs with clinical data 
x 17 hours per PMA).
    The applicant determines which records should be maintained during 
product development to document and/or substantiate the device's safety 
and effectiveness. Records required by the current good manufacturing 
practices for medical devices regulation (21 CFR part 820) may be 
relevant to a PMA review and may be submitted as part of an 
application. In individual instances, records may be required as 
conditions to approval to ensure the device's continuing safety and 
effectiveness.

    Dated: May 11, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-12277 Filed 5-15-01; 8:45 am]
BILLING CODE 4160-01-S