Draft Guidance for Industry and Food and Drug Administration Staff; Submission and Review of Sterility Information in Premarket Notification Submissions for Devices Labeled as Sterile; Availability, 75724-75725 [E8-29413]
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Federal Register / Vol. 73, No. 240 / Friday, December 12, 2008 / Notices
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
Section of the 2007 Amendments
No. of
Recordkeepers
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per
Record
Total Hours
2222
33,490
1
29,900
0.25
7,475
2232
16,524
4
66,096
0.5
33,048
Total Hours
1 There
40,523
are no capital costs or operating and maintenance costs associated with this collection of information.
burden.
jlentini on PROD1PC65 with NOTICES
2 Recurring
The estimates in Table 1 of this
document are based on FDA’s
experience, data from the device
registration and listing database, and
our estimates of the time needed to
complete the previously required forms.
We estimate that the time needed to
enter registration and listing
information electronically using FDA
Form 3673 will not differ significantly
from the time needed to fill in the paper
forms (FDA Forms 2891, 2891a, and
2892) that previously were used for this
purpose because the information
required is essentially identical.
In addition, under section 224 of
FDAAA, device establishment owner/
operators, for whom registering and
listing by electronic means is not
reasonable, may request a waiver from
the Secretary. Because a device
establishment’s owner/operator is
required to register and list, they would
need only to have access to a computer,
Internet and an e-mail address for
registration and listing by electronic
means, the agency did not anticipate
receipt of a large number of requests for
waiver. For the first few months of
operation of the web-based system, from
the October through December 2007
timeframe, FDA received fewer than 10
requests for waivers for the requirement
to submit registration and listing
information electronically. As data for
more than 16,000 establishments have
been received electronically for the
same period, these requests amount to
less than 1 percent of the total number
of establishments that have responded.
Based on information taken from our
databases, FDA estimates that there are
29,370 owner/operators who
collectively register a total of 33,490
device establishments. The number of
respondents listed for section 224 of
FDAAA in Table 1 of this document is
29,370, which corresponds to the
number of owner/operators who
annually register one or more
establishments. In addition, FDA
estimates that 4,988 owner/operators are
initial importers who must register their
establishments but who, under FDA’s
existing regulations, are not required to
VerDate Aug<31>2005
17:56 Dec 11, 2008
Jkt 217001
list their devices unless they initiate or
develop the specifications for the
devices or repackage or relabel the
devices. The number of respondents
included in Table 1 of this document for
section 223 of FDAAA is 24,382, which
corresponds to the number of owner/
operators who annually list one or more
devices (29,370 – 4,988 = 24,382).
To calculate the burden estimate for
waiver requests under section 224 of
FDAAA, we assume as stated
previously, that less than one tenth of 1
percent of the 33,490 total device
establishments would request waivers
from FDA. This means the total number
of waiver requests would probably not
exceed 20 requests (33,490 x 0.0006).
We also estimate that the one-time
burden on these establishments would
be an hour of time for a mid-level
manager to draft, approve, and mail a
letter. In addition, FDA estimates the
total number of establishments will
increase by 2,600 new establishments
each year. Of the 2,600 new registrants
each year, we assume that less than 1
percent (i.e., 1) of these will also request
waivers each year. The total, therefore,
is 21 waiver requests, which could
increase by only one additional request
each year.
The burden estimate for
recordkeeping requirements under
section 222 of FDAAA in Table 2 of this
document, complies with the
requirement that owners or operators
keep a list of officers, directors, and
partners for each establishment. Owners
or operators will need to provide this
information only upon request from
FDA. However, it is assumed that some
effort will need to be expended for
keeping such lists current.
The burden estimate for
recordkeeping requirements under
section 223 of FDAAA in Table 2 of this
document reflect other recordkeeping
requirements for devices listed with
FDA, and the requirement to provide
these records upon request from FDA.
These estimates are based on FDA
experience.
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
Dated: December 8, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–29459 Filed 12–11–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0611]
Draft Guidance for Industry and Food
and Drug Administration Staff;
Submission and Review of Sterility
Information in Premarket Notification
Submissions for Devices Labeled as
Sterile; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Submission and Review of
Sterility Information in Premarket
Notification (510(k)) Submissions for
Devices Labeled as Sterile.’’ This draft
guidance document updates and
clarifies the procedures for reviewing
premarket notification submissions
(510(k)s) for devices labeled as sterile,
particularly with respect to sterilization
technologies FDA considers novel, and
the information that should be included
in 510(k)s for devices labeled as sterile.
DATES: Although you can comment on
any guidance at any time (see 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
written or electronic comments on the
draft guidance by March 12, 2009.
ADDRESSES: Submit written requests for
single copies of the draft guidance
document entitled ‘‘Submission and
Review of Sterility Information in
Premarket Notification (510(k))
Submissions for Devices Labeled as
Sterile’’ to the Division of Small
Manufacturers, International, and
E:\FR\FM\12DEN1.SGM
12DEN1
Federal Register / Vol. 73, No. 240 / Friday, December 12, 2008 / Notices
jlentini on PROD1PC65 with NOTICES
Consumer Assistance (HFZ–220), Center
for Devices and Radiological Health
(CDRH), Food and Drug Administration,
1350 Piccard Dr., Rockville, MD 20850
or to the Office of Communication,
Training, and Manufacturers Assistance
(HFM–40), Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448. Send one selfaddressed adhesive label to assist that
office in processing your request, or fax
your request to CDRH at 240–276–3151.
The guidance may also be obtained by
mail by calling CBER at 1–800–835–
4709 or 301–827–1800. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance.
Submit written comments concerning
this draft guidance to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to https://
www.regulations.gov. 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 (HFZ–480),
Food and Drug Administration,
9200 Corporate Blvd., Rockville,
MD 20850, 240–276–3747;
Chiu Lin, Center for Devices and
Radiological Health (HFZ–480), Food
and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
240–276–3700; or
Leonard Wilson, Center for Biologics
Evaluation and Research (HFM–25),
Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852
301–827–0373.
SUPPLEMENTARY INFORMATION:
I. Background
This draft guidance document
updates and clarifies the procedures for
reviewing premarket notification
submissions (510(k)s) for devices
labeled as sterile, particularly with
respect to sterilization technologies FDA
considers novel. The draft guidance
provides details about the pyrogenicity
information we recommend be included
in 510(k)s for devices labeled as sterile.
When final, this draft will supersede the
guidance entitled ‘‘Updated 510(k)
Sterility Review Guidance K90–1’’ that
FDA issued on August 30, 2002
(available at https://www.fda.gov/cdrh/
ode/guidance/361.pdf).
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
VerDate Aug<31>2005
17:56 Dec 11, 2008
Jkt 217001
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on premarket notification submissions
for devices labeled as sterile. 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. To receive ‘‘Submission
and Review of Sterility Information in
Premarket Notification (510(k))
Submissions for Devices Labeled as
Sterile,’’ you may either send an e-mail
request to dsmica@fda.hhs.gov to
receive an electronic copy of the
document or send a fax request to 240–
276–3151 to receive a hard copy. Please
use the document number 1615 to
identify the guidance you are
requesting.
CDRH maintains an entry on the
Internet for easy access to information,
including text, graphics, and files that
may be downloaded to a personal
computer with Internet access. Updated
on a regular basis, the CDRH home page
includes device safety alerts, Federal
Register reprints, information on
premarket submissions (including lists
of approved applications and
manufacturers’ addresses), small
manufacturer’s assistance, information
on video conferencing and electronic
submissions, Mammography Matters,
and other device-oriented information.
The CDRH Web site may be accessed at
https://www.fda.gov/cdrh. A search
capability for all CDRH guidance
documents is available at https://
www.fda.gov/cdrh/guidance.html.
Guidance documents are also available
on the CBER Internet site at https://
www.fda.gov/cber/guidelines.htm or the
Division of Dockets Management
Internet site at https://
www.regulations.gov.
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
(the PRA) (44 U.S.C. 3501–3520). This
draft guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by OMB under the PRA. The
collections of information in 21 CFR
part 807, subpart E, have been approved
under OMB control number 0910–0120;
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
75725
and the collections of information in 21
CFR part 820 have been approved under
OMB control number 0910–0073.
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified 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.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
Dated: December 3, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–29413 Filed 12–11–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; The Hispanic
Community Health Study (HCHS)/
Study of Latinos (SOL)
SUMMARY: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Heart, Lung, and Blood Institute
(NHLBI), the National Institutes of
Health (NIH) has submitted to the Office
of Management and Budget (OMB) a
request for review and approval the
information collection listed below.
This proposed information collection
was previously published in the Federal
Register on October 3, 2008, page
57634, and allowed 60 days for public
comment. One comment was received.
The purpose of this notice is to allow an
additional 30 days for public comment.
The National Institutes of Health may
not conduct or sponsor, and the
respondent is not required to respond
to, an information collection that has
been extended, revised, or implemented
on or after October 1, 1995, unless it
E:\FR\FM\12DEN1.SGM
12DEN1
Agencies
[Federal Register Volume 73, Number 240 (Friday, December 12, 2008)]
[Notices]
[Pages 75724-75725]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-29413]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0611]
Draft Guidance for Industry and Food and Drug Administration
Staff; Submission and Review of Sterility Information in Premarket
Notification Submissions for Devices Labeled as Sterile; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Submission and Review of
Sterility Information in Premarket Notification (510(k)) Submissions
for Devices Labeled as Sterile.'' This draft guidance document updates
and clarifies the procedures for reviewing premarket notification
submissions (510(k)s) for devices labeled as sterile, particularly with
respect to sterilization technologies FDA considers novel, and the
information that should be included in 510(k)s for devices labeled as
sterile.
DATES: Although you can comment on any guidance at any time (see 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 written or electronic comments on the draft guidance
by March 12, 2009.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Submission and Review of Sterility
Information in Premarket Notification (510(k)) Submissions for Devices
Labeled as Sterile'' to the Division of Small Manufacturers,
International, and
[[Page 75725]]
Consumer Assistance (HFZ-220), Center for Devices and Radiological
Health (CDRH), Food and Drug Administration, 1350 Piccard Dr.,
Rockville, MD 20850 or to the Office of Communication, Training, and
Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and
Research (CBER), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852-1448. Send one self-addressed adhesive
label to assist that office in processing your request, or fax your
request to CDRH at 240-276-3151. The guidance may also be obtained by
mail by calling CBER at 1-800-835-4709 or 301-827-1800. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the guidance.
Submit written comments concerning this draft guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to https://www.regulations.gov. 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 (HFZ-
480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD
20850, 240-276-3747;
Chiu Lin, Center for Devices and Radiological Health (HFZ-480),
Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD
20850, 240-276-3700; or
Leonard Wilson, Center for Biologics Evaluation and Research (HFM-
25), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD
20852 301-827-0373.
SUPPLEMENTARY INFORMATION:
I. Background
This draft guidance document updates and clarifies the procedures
for reviewing premarket notification submissions (510(k)s) for devices
labeled as sterile, particularly with respect to sterilization
technologies FDA considers novel. The draft guidance provides details
about the pyrogenicity information we recommend be included in 510(k)s
for devices labeled as sterile. When final, this draft will supersede
the guidance entitled ``Updated 510(k) Sterility Review Guidance K90-
1'' that FDA issued on August 30, 2002 (available at https://
www.fda.gov/cdrh/ode/guidance/361.pdf).
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on premarket
notification submissions for devices labeled as sterile. 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. To receive ``Submission and Review of
Sterility Information in Premarket Notification (510(k)) Submissions
for Devices Labeled as Sterile,'' you may either send an e-mail request
to dsmica@fda.hhs.gov to receive an electronic copy of the document or
send a fax request to 240-276-3151 to receive a hard copy. Please use
the document number 1615 to identify the guidance you are requesting.
CDRH maintains an entry on the Internet for easy access to
information, including text, graphics, and files that may be downloaded
to a personal computer with Internet access. Updated on a regular
basis, the CDRH home page includes device safety alerts, Federal
Register reprints, information on premarket submissions (including
lists of approved applications and manufacturers' addresses), small
manufacturer's assistance, information on video conferencing and
electronic submissions, Mammography Matters, and other device-oriented
information. The CDRH Web site may be accessed at https://www.fda.gov/
cdrh. A search capability for all CDRH guidance documents is available
at https://www.fda.gov/cdrh/guidance.html. Guidance documents are also
available on the CBER Internet site at https://www.fda.gov/cber/
guidelines.htm or the Division of Dockets Management Internet site at
https://www.regulations.gov.
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 (the PRA) (44 U.S.C. 3501-
3520). This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by OMB under the PRA. The collections of
information in 21 CFR part 807, subpart E, have been approved under OMB
control number 0910-0120; and the collections of information in 21 CFR
part 820 have been approved under OMB control number 0910-0073.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified 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.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at https://www.regulations.gov.
Dated: December 3, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-29413 Filed 12-11-08; 8:45 am]
BILLING CODE 4160-01-S