[Federal Register: July 8, 2003 (Volume 68, Number 130)]
[Notices]
[Page 40676-40678]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08jy03-77]
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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]
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