Draft Guidance for Industry and Food and Drug Administration; Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens; Availability, 73010-73011 [05-23746]
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73010
Federal Register / Vol. 70, No. 235 / Thursday, December 8, 2005 / Notices
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Annual Frequency per
Response
Total Annual
Responses
Hours per
Response
Total Hours
50
10
21 CFR Section
1
1
50
10
150
150
7,500
1,500
9,000
170.36
570.36
Total
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of Recordkeepers
Annual Frequency per
Recordkeeping
Total Annual Records
Hours per
Recordkeeper
Total Hours
50
10
21 CFR Section
1
1
50
10
15
15
750
150
900
170.36(c)(v)
570.36(c)(v)
Total
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
The reporting requirement is for a
proposed rule that has not yet been
issued as a final rule. In developing the
proposed rule, FDA solicited input from
representatives of the food industry on
the reporting requirements, but could
not fully discuss with those
representatives the details of the
proposed notification procedure. FDA
received no comments on the agency’s
estimate of the hourly reporting
requirements, and thus has no basis to
revise that estimate at this time. In 1998,
FDA began receiving notices that were
submitted under the terms of the
proposed rule. Since it began receiving
notices, FDA has received 12 in 1998,
23 in 1999, 30 in 2000, 28 in 2001, 26
in 2002, 23 in 2003, 20 in 2004, and 22
to date in 2005, notices annually. To
date, the number of annual notices is
less than FDA’s estimate; however, the
number of annual notices could increase
when the proposed rule becomes final.
FDA received 23 notices in 1999, 30
notices in 2000, 28 notices in 2001, 26
notices in 2002, 23 notices in 2003, and
20 notices in 2004.
Dated: November 30, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–23747 Filed 12–7–05; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0434]
Draft Guidance for Industry and Food
and Drug Administration; Nucleic Acid
Based In Vitro Diagnostic Devices for
Detection of Microbial Pathogens;
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 ‘‘Nucleic Acid Based In Vitro
Diagnostic Devices for Detection of
Microbial Pathogens.’’ This draft
guidance document is being issued to
provide guidance on the types of
information and data to consider when
preparing or reviewing premarket
submissions for nucleic acid based in
vitro diagnostic devices for the
detection of microbial pathogens.
DATES: Submit written or electronic
comments on this draft guidance by
March 8, 2006.
ADDRESSES: Submit written requests for
single copies on a 3.5’’ diskette of the
guidance document entitled ‘‘Nucleic
Acid Based In Vitro Diagnostic Devices
for Detection of Microbial Pathogens’’ to
the Division of Small Manufacturers,
International, and Consumer Assistance
(HFZ–220), Center for Devices and
Radiological Health, Food and Drug
Administration, 1350 Piccard Dr.,
Rockville, MD 20850. Send one selfaddressed adhesive label to assist that
office in processing your request, or
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
FAX your request to 301–443–8818. See
the SUPPLEMENTARY INFORMATION section
for information on electronic access to
the guidance.
Submit written comments concerning
this 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.fda.gov/dockets/ecomments.
Identify comments with the docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Roxanne Shively, Center for Devices
and Radiological Health (HFZ–440),
Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 240–
276–0496 ext. 113.
SUPPLEMENTARY INFORMATION:
I. Background
This draft document is intended to
provide a basic framework for the types
of information and data that we believe
should be addressed in the premarket
review of a nucleic acid based device for
detecting microbial pathogens. This
draft guidance replaces a previously
issued document entitled ‘‘Review
Criteria for Nucleic Acid Amplificationbased in vitro Diagnostic Devices for
Direct Detection of Infectious
Microorganisms’’ (June 1993). The
current draft reflects changes in the
technologies available for nucleic acid
detection, and expanded use in clinical
laboratories. The recommendations
within this draft guidance apply broadly
to premarket review of these in vitro
diagnostic devices for detecting
microbial pathogens. Enzymatic
amplification may or may not be part of
the applied technology.
E:\FR\FM\08DEN1.SGM
08DEN1
Federal Register / Vol. 70, No. 235 / Thursday, December 8, 2005 / Notices
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 ‘‘Nucleic Acid Based In Vitro
Diagnostic Devices for Detection of
Microbial Pathogens.’’ 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
To receive ‘‘Nucleic Acid Based In
Vitro Diagnostic Devices for Detection of
Microbial Pathogens’’ by FAX, call the
CDRH Facts-On-Demand system at 800–
899–0381 or 301–827–0111 from a
touch-tone telephone. Press 1 to enter
the system. At the second voice prompt,
press 1 to order a document. Enter the
document number (1560) followed by
the pound sign (#). Follow the
remaining voice prompts to complete
your request.
Persons interested in obtaining a copy
of the draft guidance may also do so by
using the Internet. The Center for
Devices and Radiological Health (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 Division of Dockets Management
Internet site at https://www.fda.gov/
ohrms/dockets.
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 USC 3501–3520). The
collections of information addressed in
the draft guidance document have been
approved by OMB in accordance with
VerDate Aug<31>2005
16:29 Dec 07, 2005
Jkt 208001
the PRA under the regulations
governing premarket notification
submissions (21 CFR part 807, subpart
E, OMB control number 0910–0120 and
premarket approval applications 21 CFR
part 814, OMB control number 0910–
0231). The labeling provisions
addressed in the guidance have been
approved by OMB under OMB control
number 0910–0485.
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES), written or electronic
comments regarding this document.
Submit one 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. Comments
received may be seen in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: November 28, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and
Radiological Health.
[FR Doc. 05–23746 Filed 12–7–05; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program; List of Petitions Received
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: The Health Resources and
Services Administration (HRSA) is
publishing this notice of petitions
received under the National Vaccine
Injury Compensation Program (‘‘the
Program’’), as required by Section
2112(b)(2) of the Public Health Service
(PHS) Act, as amended. While the
Secretary of Health and Human Services
is named as the respondent in all
proceedings brought by the filing of
petitions for compensation under the
Program, the United States Court of
Federal Claims is charged by statute
with responsibility for considering and
acting upon the petitions.
FOR FURTHER INFORMATION CONTACT: For
information about requirements for
filing petitions, and the Program in
general, contact the Clerk, United States
Court of Federal Claims, 717 Madison
Place, NW., Washington, DC 20005,
PO 00000
Frm 00035
Fmt 4703
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73011
(202) 357–6400. For information on
HRSA’s role in the Program, contact the
Acting Director, National Vaccine Injury
Compensation Program, 5600 Fishers
Lane, Room 11C–26, Rockville, MD
20857; (301) 443–6593.
SUPPLEMENTARY INFORMATION: The
Program provides a system of no-fault
compensation for certain individuals
who have been injured by specified
childhood vaccines. Subtitle 2 of Title
XXI of the PHS Act, 42 U.S.C. 300aa–
10 et seq., provides that those seeking
compensation are to file a petition with
the U.S. Court of Federal Claims and to
serve a copy of the petition on the
Secretary of Health and Human
Services, who is named as the
respondent in each proceeding. The
Secretary has delegated his
responsibility under the Program to
HRSA. The Court is directed by statute
to appoint special masters who take
evidence, conduct hearings as
appropriate, and make initial decisions
as to eligibility for, and amount of,
compensation.
A petition may be filed with respect
to injuries, disabilities, illnesses,
conditions, and deaths resulting from
vaccines described in the Vaccine Injury
Table (the Table) set forth at Section
2114 of the PHS Act or as set forth at
42 CFR 100.3, as applicable. This Table
lists for each covered childhood vaccine
the conditions which may lead to
compensation and, for each condition,
the time period for occurrence of the
first symptom or manifestation of onset
or of significant aggravation after
vaccine administration. Compensation
may also be awarded for conditions not
listed in the Table and for conditions
that are manifested outside the time
periods specified in the Table, but only
if the petitioner shows that the
condition was caused by one of the
listed vaccines.
Section 2112(b)(2) of the PHS Act, 42
U.S.C. 300aa–12(b)(2), requires that the
Secretary publish in the Federal
Register a notice of each petition filed.
Set forth below is a list of petitions
received by HRSA on July 1, 2005,
through September 30, 2005.
Section 2112(b)(2) also provides that
the special master ‘‘shall afford all
interested persons an opportunity to
submit relevant, written information’’
relating to the following:
1. The existence of evidence ‘‘that
there is not a preponderance of the
evidence that the illness, disability,
injury, condition, or death described in
the petition is due to factors unrelated
to the administration of the vaccine
described in the petition,’’ and
2. Any allegation in a petition that the
petitioner either:
E:\FR\FM\08DEN1.SGM
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]]>Agencies
[Federal Register Volume 70, Number 235 (Thursday, December 8, 2005)]
[Notices]
[Pages 73010-73011]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-23746]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D-0434]
Draft Guidance for Industry and Food and Drug Administration;
Nucleic Acid Based In Vitro Diagnostic Devices for Detection of
Microbial Pathogens; 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 ``Nucleic Acid Based In
Vitro Diagnostic Devices for Detection of Microbial Pathogens.'' This
draft guidance document is being issued to provide guidance on the
types of information and data to consider when preparing or reviewing
premarket submissions for nucleic acid based in vitro diagnostic
devices for the detection of microbial pathogens.
DATES: Submit written or electronic comments on this draft guidance by
March 8, 2006.
ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of the guidance document entitled ``Nucleic Acid Based In
Vitro Diagnostic Devices for Detection of Microbial Pathogens'' to the
Division of Small Manufacturers, International, and Consumer Assistance
(HFZ-220), Center for Devices and Radiological Health, Food and Drug
Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-
addressed adhesive label to assist that office in processing your
request, or FAX your request to 301-443-8818. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the
guidance.
Submit written comments concerning this 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.fda.gov/dockets/ecomments. Identify comments with the
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Roxanne Shively, Center for Devices
and Radiological Health (HFZ-440), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 240-276-0496 ext. 113.
SUPPLEMENTARY INFORMATION:
I. Background
This draft document is intended to provide a basic framework for
the types of information and data that we believe should be addressed
in the premarket review of a nucleic acid based device for detecting
microbial pathogens. This draft guidance replaces a previously issued
document entitled ``Review Criteria for Nucleic Acid Amplification-
based in vitro Diagnostic Devices for Direct Detection of Infectious
Microorganisms'' (June 1993). The current draft reflects changes in the
technologies available for nucleic acid detection, and expanded use in
clinical laboratories. The recommendations within this draft guidance
apply broadly to premarket review of these in vitro diagnostic devices
for detecting microbial pathogens. Enzymatic amplification may or may
not be part of the applied technology.
[[Page 73011]]
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 ``Nucleic
Acid Based In Vitro Diagnostic Devices for Detection of Microbial
Pathogens.'' 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
To receive ``Nucleic Acid Based In Vitro Diagnostic Devices for
Detection of Microbial Pathogens'' by FAX, call the CDRH Facts-On-
Demand system at 800-899-0381 or 301-827-0111 from a touch-tone
telephone. Press 1 to enter the system. At the second voice prompt,
press 1 to order a document. Enter the document number (1560) followed
by the pound sign (). Follow the remaining voice prompts to
complete your request.
Persons interested in obtaining a copy of the draft guidance may
also do so by using the Internet. The Center for Devices and
Radiological Health (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 Division of Dockets
Management Internet site at https://www.fda.gov/ohrms/dockets.
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 USC 3501-3520).
The collections of information addressed in the draft guidance document
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 and premarket approval
applications 21 CFR part 814, OMB control number 0910-0231). The
labeling provisions addressed in the guidance have been approved by OMB
under OMB control number 0910-0485.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), written or electronic comments regarding this
document. Submit one 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. Comments received may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: November 28, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-23746 Filed 12-7-05; 8:45 am]
BILLING CODE 4160-01-S
