Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling; Availability, 24494-24495 [2011-10516]
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Federal Register / Vol. 76, No. 84 / Monday, May 2, 2011 / Notices
Carryover and Reallotment Report for
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the grantee before the allotment for the
next fiscal year may be awarded. The
Administration for Children and
Families is requesting no changes in the
collection of data with the Carryover
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amounts of obligated funds. Use of the
form is voluntary. Grantees have the
option to use another format.
Respondents:
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Carryover and Reallotment Report ..................................................................
mstockstill on DSKH9S0YB1PROD with NOTICES6
Estimated Total Annual Burden
Hours: 576.
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Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
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[FR Doc. 2011–10458 Filed 4–29–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0293]
Draft Guidance for Industry and FDA
Staff: Processing/Reprocessing
Medical Devices in Health Care
Settings: Validation Methods and
Labeling; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
document entitled ‘‘Draft Guidance for
Industry and FDA Staff: Processing/
Reprocessing Medical Devices in Health
Care Settings: Validation Methods and
Labeling.’’ The recommendations in this
guidance are intended to improve the
safety and effectiveness of devices with
processing or reprocessing labeling.
This draft guidance is not final; nor is
it in effect at this time.
DATES: Although you can comment on
any guidance at any time (see § 10.115
(21 CFR 10.115(g)(5))), to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance, submit
electronic or written comments on the
draft guidance by August 1, 2011.
ADDRESSES: Submit written requests for
single copies of the draft guidance
document entitled ‘‘Draft Guidance for
Industry and FDA Staff: Processing/
Reprocessing Medical Devices in Health
Care Settings: Validation Methods and
Labeling’’ to the Division of Small
Manufacturers, International, and
Consumer Assistance, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 4613,
Silver Spring, MD 20993–0002. Send a
fax request to 301–847–8149 to receive
a hard copy. Alternatively, you may
SUMMARY:
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
1
Average
burden hours
per response
3
Total burden
hours
576
submit written requests for single copies
of the draft guidance to the Office of
Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852. Send one self-addressed
adhesive label to the office that you are
ordering from to assist in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for information on
electronic access to the guidance.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Steven Turtil, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 1570,
Silver Spring, MD 20993–0002, 301–
796–6305; or
Stephen Ripley, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852, 301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
In recent years, there has been a
significant advance in knowledge and
technology involved in reprocessing
reusable medical devices. Additionally,
there has been an evolution towards
more complex reusable medical device
designs that are more difficult to clean
and disinfect or sterilize. The revision of
this guidance, originally published in
1996, reflects scientific advances in this
area. Under FDA labeling regulations
(part 801 (21 CFR part 801)), a device
must have adequate directions for use,
which include instructions on preparing
a device for use. Instructions on how to
E:\FR\FM\02MYN1.SGM
02MYN1
Federal Register / Vol. 76, No. 84 / Monday, May 2, 2011 / Notices
reprocess (i.e., clean and disinfect or
sterilize) a reusable device are critical to
ensuring a reusable device is
appropriately prepared for its next use.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (§ 10.115). The draft
guidance, when finalized, will represent
the Agency’s current thinking on
processing and reprocessing labeling for
medical devices. It does not create or
confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statute
and regulations.
mstockstill on DSKH9S0YB1PROD with NOTICES6
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by using
the Internet. A search capability is
available for all CDRH guidance
documents at https://www.fda.gov/
MedicalDevices/DeviceRegulation
andGuidance/GuidanceDocuments/
default.htm, and for CBER guidance
documents at https://www.fda.gov/
BiologicsBloodVaccines/Guidance
ComplianceRegulatoryInformation/
default.htm. Guidance documents are
also available at https://
www.regulations.gov. To receive ‘‘Draft
Guidance for Industry and FDA Staff:
Processing/Reprocessing Medical
Devices in Health Care Settings:
Validation Methods and Labeling,’’ you
may either send an email request to
dsmica@fda.hhs.gov to receive an
electronic copy of the document or send
a fax request to 301–847–8149 to receive
a hard copy. Please use the document
number 1748 to identify the guidance
you are requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance contains
information collection provisions that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 807,
subpart E are approved under OMB
control number 0910–0120; the
collections of information in part 801
are approved under OMB control
number 0910–0485; and the collections
of information in 21 CFR part 812 are
approved under OMB control number
0910–0078.
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
VerDate Mar<15>2010
17:48 Apr 29, 2011
Jkt 223001
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: April 26, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2011–10516 Filed 4–29–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0294]
Reprocessing of Reusable Medical
Devices; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled: ‘‘Reprocessing of Reusable
Medical Devices Workshop.’’ The
purpose of the workshop is to discuss
factors affecting the reprocessing of
reusable medical devices and FDA’s
plans to address the identified issues.
This workshop is part of an ongoing
FDA effort to address patient exposure
to inadequately reprocessed reusable
medical devices with the overall goal to
reduce the risk of infection. The topics
to be discussed are: Factors affecting
reprocessing quality, device design as it
relates to reprocessing reusable medical
devices, reprocessing methodologies,
validation methodologies, and
healthcare facility best practices.
Date and Time: The public workshop
will be held on June 8, 2011, from
8:30 a.m. to 5:30 p.m. and June 9, 2011,
from 8:30 a.m. to 5 p.m.
Location: The public workshop will
be held in the Great Room at the FDA
White Oak Conference Center, Bldg. 31,
Rm. 1503, 10903 New Hampshire Ave.,
Silver Spring, MD 20993.
Contact Person: Carol Krueger, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5437,
Silver Spring, MD 20993, 301–796–
3241, FAX: 301–847–8510, or e-mail:
Carol.Krueger@fda.hhs.gov.
Registration and Requests for Oral
Presentations: Registration is free and
on a first-come, first-served basis.
Persons interested in attending this
PO 00000
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24495
workshop must register online by 5 p.m.
on June 1, 2011. Early registration is
recommended because facilities are
limited and, therefore, FDA may limit
the number of participants from each
organization. If time and space permit,
on-site registration on the day of the
public workshop will be provided
beginning at 7:30 a.m. Non-U.S. citizens
are subject to additional security
screening, and they should register as
soon as possible. If you need special
accommodations due to a disability,
please contact Susan Monahan (e-mail:
Susan.Monahan@fda.hhs.gov or phone:
301–796–5661) no later than June 1,
2011.
This workshop will also be Web cast.
Persons interested in participating by
Web cast must register online by 5 p.m.
on June 1, 2011. Early registration is
recommended because Web cast
connections are limited. Organizations
are requested to register all participants,
but view using one connection per
location. Web cast participants will be
sent connection requirements.
To register for the public workshop,
please visit the following Web site:
https://www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm (or go to the FDA Medical
Devices News & Events—Workshops &
Conferences calendar and select this
public workshop from the posted events
list). Please provide complete contact
information for each attendee,
including: Name, title, affiliation,
address, email, telephone and FAX
number. For those without Internet
access, please call the contact person to
register. Registrants will receive
confirmation once they have been
accepted. You will be notified if you are
on a waitlist.
This workshop includes a public
comment session. During online
registration you may indicate if you
wish to make an oral presentation
during a public comment session at the
public workshop, and which topic you
wish to address in your presentation.
FDA has included general topics for
comment in this document. FDA will do
its best to accommodate requests to
speak. Individuals and organizations
with common interests are urged to
consolidate or coordinate their
presentations, and request time for a
joint presentation. FDA will determine
the amount of time allotted to each
presenter and the approximate time
each oral presentation is to begin. All
requests to make oral presentations, as
well as presentation materials, must be
sent to the contact person by June 1,
2011.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\02MYN1.SGM
02MYN1
]]>Agencies
[Federal Register Volume 76, Number 84 (Monday, May 2, 2011)]
[Notices]
[Pages 24494-24495]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-10516]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0293]
Draft Guidance for Industry and FDA Staff: Processing/
Reprocessing Medical Devices in Health Care Settings: Validation
Methods and Labeling; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance document entitled ``Draft Guidance
for Industry and FDA Staff: Processing/Reprocessing Medical Devices in
Health Care Settings: Validation Methods and Labeling.'' The
recommendations in this guidance are intended to improve the safety and
effectiveness of devices with processing or reprocessing labeling. This
draft guidance is not final; nor is it in effect at this time.
DATES: Although you can comment on any guidance at any time (see Sec.
10.115 (21 CFR 10.115(g)(5))), to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance, submit electronic or written comments on the
draft guidance by August 1, 2011.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Draft Guidance for Industry and FDA Staff:
Processing/Reprocessing Medical Devices in Health Care Settings:
Validation Methods and Labeling'' to the Division of Small
Manufacturers, International, and Consumer Assistance, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002.
Send a fax request to 301-847-8149 to receive a hard copy.
Alternatively, you may submit written requests for single copies of the
draft guidance to the Office of Communication, Outreach and Development
(HFM-40), Center for Biologics Evaluation and Research, 1401 Rockville
Pike, suite 200N, Rockville, MD 20852. Send one self-addressed adhesive
label to the office that you are ordering from to assist in processing
your requests. See the SUPPLEMENTARY INFORMATION section for
information on electronic access to the guidance.
Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
Steven Turtil, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1570,
Silver Spring, MD 20993-0002, 301-796-6305; or
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17),
Food and Drug Administration, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
In recent years, there has been a significant advance in knowledge
and technology involved in reprocessing reusable medical devices.
Additionally, there has been an evolution towards more complex reusable
medical device designs that are more difficult to clean and disinfect
or sterilize. The revision of this guidance, originally published in
1996, reflects scientific advances in this area. Under FDA labeling
regulations (part 801 (21 CFR part 801)), a device must have adequate
directions for use, which include instructions on preparing a device
for use. Instructions on how to
[[Page 24495]]
reprocess (i.e., clean and disinfect or sterilize) a reusable device
are critical to ensuring a reusable device is appropriately prepared
for its next use.
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (Sec. 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on processing
and reprocessing labeling for medical devices. It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statute and regulations.
III. Electronic Access
Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. A search capability is available for all CDRH
guidance documents at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, and for CBER
guidance documents at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Guidance documents
are also available at https://www.regulations.gov. To receive ``Draft
Guidance for Industry and FDA Staff: Processing/Reprocessing Medical
Devices in Health Care Settings: Validation Methods and Labeling,'' you
may either send an email request to dsmica@fda.hhs.gov to receive an
electronic copy of the document or send a fax request to 301-847-8149
to receive a hard copy. Please use the document number 1748 to identify
the guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance contains information collection provisions that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 807, subpart E are approved
under OMB control number 0910-0120; the collections of information in
part 801 are approved under OMB control number 0910-0485; and the
collections of information in 21 CFR part 812 are approved under OMB
control number 0910-0078.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: April 26, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-10516 Filed 4-29-11; 8:45 am]
BILLING CODE 4160-01-P
