[Federal Register Volume 65, Number 179 (Thursday, September 14, 2000)]
[Notices]
[Pages 55633-55634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-23546]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1494]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Medical Devices; Classification/Reclassification; 
Restricted Devices: Analyte Specific Reagents

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 
(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 labeling requirements for 
certain in vitro diagnostic products for manufacturers of analyte 
specific reagents (ASR's).

DATES: Submit written or electronic comments on the collection of 
information by November 13, 2000.

ADDRESSES: Submit electronic comments on the collection of information 
via the Internet at: http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.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: 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.
    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.

Medical Devices: Classification/Reclassification; Restricted 
Devices; Specific Reagents--21 CFR Part 809 (OMB No. 0910-0361)--
Extension

    Section 513 of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 360c) requires that FDA classify all devices into one of 
three classes depending on the degree of regulatory control needed to 
provide reasonable assurance of their safety and effectiveness. The 
three classes of devices are: Class I, general controls; class II, 
special controls; and class III, premarket approval. Section 502 of the 
act (21 U.S.C. 352) establishes certain labeling requirements for 
devices including requirements that the labeling not be false or 
misleading in any particular, that the labeling contain the established 
name for the device, and that the labeling contain adequate directions 
for use. Section 520(e) of the act (21 U.S.C. 360j(e)) provides that 
FDA may restrict the sale, distribution, or use of a device, if FDA 
determines that there cannot otherwise be reasonable assurance of its 
safety and effectiveness. Sections 502(q) and (r) of the act authorizes 
FDA to regulate the advertising of devices that are restricted under 
section 520(e) of the act.
    FDA restricts distribution of analyte specific reagents to 
laboratories certified under the Clinical Laboratory Improvement 
Amendments of 1988 as qualified to perform high complexity

[[Page 55634]]

testing to manufacturers of in vitro diagnostic products and to 
organizations that use the tests for reasons other than providing 
diagnostic information to physicians and patients. FDA has established 
certain labeling requirements for suppliers of ASR's and some 
requirements regarding advertising and promotional materials for ASR's. 
FDA believes the labeling requirements and restrictions on advertising 
and promotion are necessary to ensure that laboratories developing 
tests from ASR's have sufficient information to use the ASR's 
appropriately and to limit specific claims by manufacturers, because 
these ASR's are intended to be used as ingredients in a variety of ways 
by laboratories qualified to do high complexity testing.
    The most likely respondents to this information collection will 
primarily be medical device manufacturers of in vitro products, 
clinical laboratories, and third parties.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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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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809.10(e)                             300              25           7,500               1           7,500
809.30(d)                             300              25           7,500               1           7,500
Totals                                                                                            15,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The burden is based on the estimate and averaging of five 
establishments. The number of establishments manufacturing or supplying 
ASR's ranged from 100 to 500 with the average being 300. Consequently, 
FDA estimates the number of ASR manufacturers and suppliers subject to 
the reporting requirements is approximately 300.
    The number of ASR's being manufactured was derived by asking the 
same five establishments. Three of the establishments gave estimates 
for the number of ASR's that ranged from 5,000 to 10,000, with the 
average being 7,500.
    In order to determine the number of ASR's manufactured by each 
respondent, FDA used the average number of ASR's manufactured and 
divided it by the number of ASR manufacturers (7,500  300). 
Consequently, the estimate of the number of ASR's manufactured by each 
respondent is approximately 25.
    FDA estimates for each ASR, it adds approximately 1 additional hour 
to the design and review process for new labels to conform with the 
requirements of Sec. 809.10(e) (21 CFR 890.10(e)). FDA also estimates 
that the total reporting hour burden is approximately 7,500 hours (300 
x 25).
    FDA estimates for each ASR it adds approximately 1 hour to the 
preparation and review time for the professional materials to ascertain 
compliance with Sec. 809.30(d). FDA estimates that the total reporting 
hour burden for promotional materials is approximately 7,500 (300 X 
25).

    Dated: September 7, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-23546 Filed 9-13-00; 8:45 am]
BILLING CODE 4160-01-F