[Federal Register Volume 62, Number 189 (Tuesday, September 30, 1997)]
[Notices]
[Pages 51112-51114]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25938]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0385]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request

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 (the PRA).

DATES: Submit written comments on the collection of information by 
October 30, 1997.
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: 
Desk Officer for FDA.

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

SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA 
(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--Part 814 (OMB Control Number 
0910-0231--Reinstatement)

    Section 515 of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 360e) sets forth requirements for premarket approval of 
certain medical 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 
safe and effective; a statement of components; 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 premarket approval application (PMA) 
for a medical device and the criteria FDA will employ in approving, 
denying, or withdrawing approval of a PMA. The purpose of these 
regulations is to establish an efficient and thorough procedure for 
FDA's review of PMA's for class III (premarket approval) medical 
devices, in order to facilitate the approval of PMA's for devices that 
have been shown to be safe and effective and otherwise meet the 
statutory criteria for approval and to ensure the disapproval of PMA's 
for devices that have not been shown to be safe and effective and that 
do not otherwise meet the statutory criteria for approval.
    Under Sec. 814.15, an applicant may submit in support of a PMA 
studies from research conducted outside the United States, but an 
applicant must explain in detail any differences between standards used 
in a study to support the PMA's and those standards found in the 
Declaration of Helsinki. Section 814.20 provides a list of information 
required in the PMA, including: A summary of information in the 
application, a complete description of the device, technical and 
scientific information, and copies of proposed labeling. Section 814.37 
provides requirements for an applicant who seeks to amend a pending 
PMA. Under Sec. 814.39, an applicant must submit a supplement to the 
PMA before making a change affecting the safety or effectiveness of the 
device. Section 814.82 sets forth postapproval requirements FDA may 
propose, including periodic reporting on safety, effectiveness, 
reliability, and display in the labeling and advertising of certain 
warnings. Section 814.82 requires the maintenance of records to trace 
patients and the organizing and indexing of records into identifiable 
files to enable

[[Page 51113]]

FDA to determine whether there is reasonable assurance of the device's 
continued safety and effectiveness. Section 814.84 specifies the 
contents of periodic reports. The applicant determines what 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 
part 820 (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 to be maintained as conditions of approval to ensure 
the device's continuing safety and effectiveness.
    Respondents to this information collection are persons filing an 
application for approval of a Class III medical device. 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 
manufacturers of commercial medical devices in distribution prior to 
May 28, 1976 (the enactment date of the Medical Device Amendments).
    FDA estimates the burden of this collection of information as 
follows:

                                   Table 1.--Estimated Annual Reporting Burden                                  
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                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
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814.15, 814.20, and 814.37             52               1              52             837.28       43,539       
814.39                                493               1             493              73.15       36,063       
814.82                                545               1             545               9.14        4,983       
814.84                                545               1             545              18.29        9,966       
Total                                                                                              94,551       
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There are no capital costs or operating and maintenance costs associated with this collection of information.   

    In March 1997, while completing work on the CDRH Annual Information 
Collection Budget, an error was discovered on this information 
collection's burden hours by CDRH program staff. This error was not 
discovered until after the publishing of this information collection's 
60-day notice in the Federal Register of January 7, 1997 (62 FR 995), 
Docket No. 96N-0491. The narrative portion of the Federal Register 
notice correctly stated that 52 original PMA's and 493 PMA Supplements 
were processed each year. The burden chart, however, incorrectly stated 
that 545 original PMA's and 545 PMA Supplements were processed each 
year (the 545 figure was derived by adding the 52 original and 493 PMA 
supplements together). When the correct number of respondents was 
plugged into the burden hour table and the numbers recalculated, the 
new total burden hours equals 104,020 hours, a savings of 416,583 hours 
from the original 1997 figure of 520,603.

                                 Table 2.--Estimated Annual Recordkeeping Burden                                
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                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper                 
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814.82 (a) (5) and (a) (6)            567               1             567              16.7         9,469       
Total                                                                                               9,469       
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There are no capital costs or operating and maintenance costs associated with this collection of information.   

    FDA estimates that the cost to device manufacturers to comply with 
the requirements for premarket approval of medical devices is 
approximately $34.95 million per year. The industry-wide cost estimate 
for PMA's is based on an average fiscal year annual rate of receipt of 
52 PMA original applications and 493 PMA supplements, using fiscal 
years 1991 through 1995 data.
    The cost data for PMA's is based on data provided by manufacturers 
in 1985 by device type and cost element. The specific cost elements for 
which FDA has data are as follows:
    (1) Clinical investigations: 67 percent of total cost estimate,
    (2) Submitting 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.
    A weighted average calculation in 1985 produced a total cost of 
$280,000 for a PMA application. These cost estimates are considered to 
be solely attributable to PMA requirements. FDA does not have more 
recent data on the cost to manufacturers of collecting, analyzing, and 
preparing the data needed for a PMA submission. FDA has adjusted the 
1985 estimate for inflation (using an average of 7.5 percent per year 
for the health care sector) and multiplied it by 52 (the average number 
of PMA's submitted annually) to yield an annual cost attributable to 
PMA's of $32,323,200 ($280,000 x index of 2.22 x 52).
    FDA estimates that 493 PMA supplements will be submitted annually. 
No recent information on the cost of PMA supplements has been collected 
from medical device manufacturers. However, the agency has taken an 
earlier cost estimate for PMA supplements ($2,400 per supplement) and 
adjusted it for inflation. The annual cost of PMA supplements is 
estimated to be $2,626,704 (493 x $2,400 x 2.22 index factor).
    Thus, the cost estimate for PMA's and PMA supplements is 
$34,949,904. This figure represents the burden on industry due to the 
PMA approval requirement. This cost includes both the effect of the 
statutory requirement and the effect of the agency's implementation of 
the statute.
    The recordkeeping burden in this section requires the maintenance 
of

[[Page 51114]]

records to trace patients, and the organization and indexing of records 
into identifiable files to ensure the device's continued safety and 
effectiveness. These requirements are to be performed only by 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, about 27 PMA's a year 
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, so there 
are around 567 active PMA's that could be subject to these requirements 
(21 years x 27 per year). Each study has about approximately 200 
subjects, and, at an average of 5 minutes per subject, there is a total 
burden per study of 1,000 minutes, or 16.7 hours. The aggregate burden 
for all 567 holders of approved original PMA's, therefore, is 9,469 
hours (567 approved PMA's with clinical data x 16.7 hours per PMA).
    The applicant determines what 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 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.
    With the additional 9,469 hours or recordkeeping, the total annual 
burden is 104,020 hours.

    Dated: September 23, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-25938 Filed 9-29-97; 8:45 am]
BILLING CODE 4160-01-F