[Federal Register Volume 62, Number 4 (Tuesday, January 7, 1997)]
[Notices]
[Pages 995-996]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-291]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 96N-0491]


Agency Information Collection Activities: Proposed Collection; 
Reinstatement

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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, 
Federal agencies are required to publish notice in the Federal Register 
concerning each proposed collection of information, including each 
proposed reinstatement of an existing collection of information, and to 
allow 60 days for public comment in response to the notice. This notice 
solicits comments on requirements for premarket approval applications 
(PMA's) that are submitted under part 814 (21 CFR part 814).

DATES: Submit written comments on the collection of information 
requirements by March 10, 1997.

ADDRESSES: Submit written comments on the collection of information 
requirements to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All 
comments should be identified with the docket number found in brackets 
in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Margaret R. Wolff, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857, 
301-827-1223.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(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 
reinstatement 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 listed below.
    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--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, further specify the 
contents of a 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 show 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,

[[Page 996]]

effectiveness, and reliability, and display in the labeling and 
advertising of certain warnings. Section 814.84 specifies the contents 
of periodic reports. Section 814.82 requires the maintenance of records 
to trace patients and the organizing and indexing of records into 
identifiable files to enable FDA to determine whether there is 
reasonable assurance of the device's continued safety and 
effectiveness. 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 (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 with the Secretary of Health and Human Services 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:

                                        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            545               1             545             837.28      456,320       
814.39                                545               1             545              73.15       39,865       
814.82                                545               1             545               9.14        4,983       
814.84                                545               1             545              18.29        9,966       
Total Hours                                                                                       511,134       
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There are no capital costs or operating and maintenance costs associated with this collection of information.   


                                      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.   


    Dated: December 31, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-291 Filed 1-6-97; 8:45 am]
BILLING CODE 4160-01-F