[Federal Register Volume 66, Number 27 (Thursday, February 8, 2001)]
[Notices]
[Pages 9582-9585]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-3323]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0050]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Medical Devices; Classification/Reclassification; 
Restricted Devices: Premarket Approval of Medical Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing information 
collection, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on information collection 
requirements for premarket approval of medical devices.

DATES: Submit written or electronic comments on the collection of 
information by April 9, 2001.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. All comments should be identified 
with the docket number found in brackets in the heading of this 
document.

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

    Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain 
approval from the Office of Management and Budget (OMB) for each 
collection of information they conduct or sponsor. ``Collection of 
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and 
includes agency requests or requirements that members of the public 
submit reports, keep records, or provide information to a third party. 
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each 
proposed extension of an existing collection of information, before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.

[[Page 9583]]

    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

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 which 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 (PMA's) 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 PMA's. The 
regulation's purpose is to establish an efficient and thorough 
procedure for FDA's review of PMA's and supplements to PMA's for 
certain class III (premarket approval) medical devices. The regulations 
contained in part 814 facilitate the approval of PMA's and supplements 
to PMA's 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 PMA's and supplements to 
PMA's for devices that have not been show 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 re-use single use 
devices (SUD's) are 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 SUD's. This figure has 
been included in table 1 of this document as part of the reporting 
burden in Sec. 814.15.
    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\
----------------------------------------------------------------------------------------------------------------
                                      Annual Frequency per   Total Annual      Hours per
21 CFR Section   No. of Respondents          Response          Responses       Response          Total Hours
----------------------------------------------------------------------------------------------------------------
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)
Totals                                                                                          92,021
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 9584]]


                               Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
                                            Annual Frequency per   Total Annual      Hours per
   21 CFR Section     No. of Recordkeepers      Recordkeeping         Records      Recordkeeper     Total Hours
----------------------------------------------------------------------------------------------------------------
814.82(a)(5) and             900                     1                900              17          15,300
 (a)(6)
Totals                                                                                             15,300
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The industry-wide burden estimate for PMA's 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 PMA's 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 re-manufacturers 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 ten 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 PMA's that were not 
reclassified and require a periodic report. In the last decade (1991 to 
2000), the range of PMA's that fit this category averaged approximately 
43 per year (70 percent of the 62 periodic submissions). Most approved 
PMA's have been subject to some post approval study requirement. 
Approximately half of the average submitted PMA's (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 PMA's require minimal information. Based on its experience 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 PMA's 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 PMA's are eventually approved and 75 percent of those 
have original clinical trial data. Therefore, approximately 43 PMA's a 
year (62 annual submissions times 70 percent) would be subject to these 
requirements. Also, because the requirements apply to all active PMA's, 
all holders of active PMA applications must maintain these records. 
PMA's have been required since 1976, and there are 900 active PMA's 
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 PMA's, therefore, is 15,300 hours (900 approved PMA's 
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

[[Page 9585]]

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: February 2, 2001.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 01-3323 Filed 2-7-01; 8:45 am]
BILLING CODE 4160-01-S