[Federal Register Volume 61, Number 169 (Thursday, August 29, 1996)]
[Notices]
[Pages 45432-45433]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22122]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0261]


Agency Information Collection Activities: Proposed Collection; 
Comment Request; 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 relating to the submission of 
reclassification petitions for medical devices.

DATES: Submit written comments on the collection of information by 
October 28, 1996.

ADDRESSES: Submit written comments on the collection of information 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: Charity B. Smith, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857, 
301-827-1686.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(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.


Reclassification Petitions for Medical Devices--21 CFR Part 860 (OMB 
Control Number 0910-0138)

 Type of OMB Approval Requested: Reinstatement Without Change of a 
Previously Approved Collection for Which Approval has Expired
    FDA has the responsibility under sections 513(e), 513(f), 514(b), 
515(b), and 520(l) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 360c(e) and (f), 360d(b), 360e(b), and 360j(l)) and 21 
CFR part 860, subpart C, to collect data and information contained in 
reclassification petitions. The reclassification provisions of the act 
allow any person to petition for reclassification of a medical device 
from

[[Page 45433]]

any one of three classes (I, II, III) to another class. The 
reclassification procedures regulation (Sec. 860.123) requires the 
submission of sufficient, valid scientific evidence demonstrating that 
the proposed classification will provide a reasonable assurance of 
safety and effectiveness of the device for its intended use. The 
reclassification provisions of the act serve primarily as a vehicle for 
manufacturers to seek reclassification from a higher to a lower class, 
thereby reducing the regulatory requirements applicable to a particular 
device. The reclassification petitions requesting downclassification 
from class III to class II or class I, if approved, provide an 
alternative route to the market in lieu of premarket approval for class 
III devices.
    FDA estimates the burden of this collection of information as 
follows:

                                        Estimated Annual Reporting Burden                                       
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                                       Annual Frequency     Total Annual        Hours per                       
 21 CFR Section   No. of Respondents     per Response        Responses           Response         Total Hours   
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860.123.........         11                   1                 11                500              5,500        
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There are no capital costs or operating and maintenance costs associated with this collection of information.   

    Based on current trends, FDA anticipates that 11 petitions will be 
submitted each year. The time required to prepare and submit a 
reclassification petition, including the time needed to assemble 
supporting data, averages 500 hours per petition. This average is based 
upon estimates by FDA administrative and technical staff who are 
familiar with the requirements for submission of a reclassification 
petition, have consulted and advised manufacturers on these 
requirements, and have reviewed the documentation submitted.

    Dated: August 21, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-22122 Filed 8-28-96; 8:45 am]
BILLING CODE 4160-01-F