[Federal Register Volume 68, Number 130 (Tuesday, July 8, 2003)]
[Notices]
[Pages 40676-40678]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 03-17136]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03N-0191]


Agency Emergency Processing Under OMB Review; Submission of 
Validation Data for Reprocessed Single-Use Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for emergency processing under the 
Paperwork Reduction Act of 1995 (the PRA). The proposed collection of 
information will be used by FDA to determine whether reprocessed 
single-use devices (SUDs) are substantially equivalent to legally 
marketed predicate devices. FDA is requesting this emergency processing 
under the PRA to implement the statutory provision under section 302 of 
the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).

DATES: Submit comments on the collection of information by August 7,

[[Page 40677]]

2003. FDA is requesting approval of this emergency processing by August 
22, 2003.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that written comments be 
electronically mailed to sshapiro@omb.eop.gov or faxed to the Office of 
Information and Regulatory Affairs, OMB, Attn: Stuart Shapiro, Desk 
Officer for FDA, FAX: 202-395-6974. All comments should be identified 
with the docket number found in brackets in the heading of this 
document.

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

SUPPLEMENTARY INFORMATION: FDA has requested emergency processing of 
this proposed collection of information under section 3507(j) of the 
PRA (44 U.S.C. 3507(j) and 5 CFR 1320.13). This information is needed 
immediately so that the agency can provide guidance to implement the 
statutory provision under section 302 of MDUFMA requiring manufacturers 
to submit validation data for certain reprocessed SUDs. Under section 
302 of MDUFMA, FDA was required to publish a list of reprocessed SUDs 
currently subject to premarket notification requirements for which 
validation data are necessary, as well as a list of reprocessed SUDs 
for which an existing exemption from premarket notification 
requirements will no longer apply. Manufacturers of reprocessed SUDs 
included in these lists are required by MDUFMA to submit validation 
data (through the appropriate mechanism) within timeframes specified in 
the statute.
    MDUFMA was signed into law on October 26, 2002. The use of normal 
clearance procedures would likely result in the prevention or 
disruption of this collection of information. Therefore, FDA has 
requested approval of this emergency processing of this proposed 
collection of information by (see DATES).
    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.

Submission of Validation Data for Reprocessed Single Use Devices

    Section 302(b) of MDUFMA adds new requirements for reprocessed SUDs 
to section 510 of the Food Drug and Cosmetic Act (the act) (21 U.S.C. 
360)). One of MDUFMA's provisions requires the submission of validation 
data specified in the statute for certain reprocessed SUDs (as 
identified by FDA). The types of validation data include cleaning and 
sterilization data and functional performance data.
    MDUFMA requires that FDA review the types of reprocessed SUDs now 
subject to premarket notification requirements and identify which of 
these devices require the submission of validation data to ensure their 
substantial equivalence to predicate devices. MDUFMA also requires that 
FDA review critical and semi-critical reprocessed SUDs that are 
currently exempt from premarket notification requirements and determine 
which of these devices require the submission of 510(k)s to ensure 
their substantial equivalence to predicate devices. Under MDUFMA, the 
validation data submitted for a reprocessed SUD must demonstrate that 
the device will remain substantially equivalent to its predicate after 
the maximum number of times the device is reprocessed as intended by 
the person submitting the premarket notification.
    On April 30, 2003 (68 FR 23139), as required by MDUFMA, FDA 
published two lists in the Federal Register: (1) A list of critical 
reprocessed SUDs whose exemption from 510(k) requirements will be 
terminated; and (2) a list of reprocessed SUDs that are currently 
subject to 510(k) requirements for which validation data must be 
submitted. FDA will update these lists as necessary.
    The validation data required by MDUFMA must be submitted according 
to the following timetable:
    [sbull] After publication of the lists manufacturers submitting new 
510(k)s for listed devices must include validation data.
    [sbull] Within 9 months after publication of the list (by January 
30, 2004), manufacturers of listed devices with 510(k)s pending for 
these devices at the time the lists were published should either 
supplement these 510(k)s with validation data or resubmit them with 
validation data after clearance.
    [sbull] Manufacturers of listed devices with 510(k)s for these 
devices cleared by FDA before publication of the lists must submit 
validation data for these devices within 9 months after publication of 
the lists (by January 30, 2004).
    [sbull] Manufacturers of listed devices that were previously exempt 
from 510(k) submission requirements must submit validation data for 
these devices in 510(k) submissions within 15 months after publication 
of the lists (July 30, 2004).
    [sbull] By April 26, 2004, FDA must publish a list of semi-critical 
reprocessed SUDs that will require the submission of validation data in 
510(k) submissions. The publication of this list will trigger 
submission timeframes the same as those in the previous paragraphs.
    Respondents to the proposed collection of information will likely 
be businesses or other for-profit organizations.
    FDA estimates the burden of this information collection as follows:

                                 Table 1.--Estimated Annual Reporting Burden \1\
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                                Annual rrequency        Total annual
   Item    No. of respondents     per response           responses        Hours per response      Total hours
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Submissio         20                   5                   100                   40               4,000
 n of
 validati
 on data
 (2003)
Submissio         20                  20                   400                   40              16,000
 n of
 validati
 on data
 (2004)
Submissio         20                  10                   200                   40               8,000
 n of
 validati
 on data
 (2005)

[[Page 40678]]

 
Total      ..................  ..................  .....................  ..................     28,000
 Hours
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on submissions received to date and registration and listing 
records for the affected devices, FDA estimates that there are 20 
reprocessors of SUDs that will need to submit validation data. In 
calendar year 2003, FDA estimates that there will be 5 new 510(k)s for 
reprocessed SUDs. Based on its experience with reviewing 510(k)s and 
discussions with reprocessors, FDA estimates that it will take 40 hours 
per 510(k) to develop and submit the validation data. This results in a 
total burden of 4,000 for 2003. (In this estimate, FDA is only taking 
into account the burden related to validation data. The other 
collections of information related to the submission of information in 
a 510(k) have been approved by OMB in accordance with the PRA under the 
regulations governing premarket notification submissions (21 CFR part 
807, subpart E, OMB control number 0910-0120).
    In 2004, reprocessors with previously exempt and cleared devices 
will need to submit their validation data by January 30, 2004, and July 
30, 2004. For 2004, FDA estimates that the 20 manufacturers will submit 
an average of 20 510(k)s each for a total burden of 16,000 hours.
    In 2005, FDA estimates that the 20 manufacturers will submit 10 new 
510(k)s each. This will result in a total burden of 8,000.

    Dated: July 1, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-17136 Filed 7-7-03; 8:45 am]
BILLING CODE 4160-01-S