Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Investigational Device Exemptions Reports and Records, 63766-63768 [E6-18200]
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Federal Register / Vol. 71, No. 210 / Tuesday, October 31, 2006 / Notices
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.
MDUFMA Small Business Qualification
Certification (Form FDA 3602)—(OMB
Control Number 0910–0508)—Extension
MDUFMA amends the Federal Food,
Drug, and Cosmetic Act to provide for
user fees for certain medical device
applications. FDA published a Federal
Register notice on August 2, 2006 (71
FR 43784 through 43786), announcing
fees for fiscal year (FY) 2007. To avoid
harming small businesses, MDUFMA
provides for reduced or waived fees for
applicants who qualify as a ‘‘small
business.’’ This means there are two
levels of fees, a standard fee, and a
reduced or waived small business fee.
For FY 2006, you can qualify for a
small business fee discount under
MDUFMA if you reported gross receipts
or sales of no more than $100 million
on your Federal income tax return for
the most recent tax year. If you have any
affiliates, partners, or parent firms, you
must add their gross receipts or sales to
yours, and the total must be no more
than $100 million. If your gross receipts
or sales are no more than $30 million
(including all of your affiliates, partners,
and parent firms), you will also qualify
for a waiver of the fee for your first
(ever) premarket application (premarket
approval (PMA), product development
protocol (PDP), biologic license
application (BLA), or Premarket Report).
An applicant must pay the full standard
fee unless it provides evidence
demonstrating to FDA that it meets the
‘‘small business’’ criteria. The evidence
required by MDUFMA is a copy of the
most recent Federal income tax return of
the applicant, and any affiliate, partner,
or parent firm. FDA will review these
materials and decide whether an
applicant is a ‘‘small business’’ within
the meaning of MDUFMA.
Form FDA 3602 is available in a
guidance document entitled ‘‘Guidance
for Industry and FDA: FY 2006
MDUFMA Small Business Qualification
Worksheet and Certification.’’ This
guidance describes the criteria FDA will
use to decide whether an entity qualifies
as a MDUFMA small business and will
help prospective applicants understand
what they need to do to meet the small
business criteria for FY 2006 and
subsequent fiscal years.
Description of Respondents:
Respondents will be businesses or other
for-profit organizations.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
FDA Form Number
3602
Annual Frequency
per Response
2,000
Total Annual
Responses
1
Hours per
Response
2,000
1
Total
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden is based on the number of
applications received in the last 3 years.
Dated: October 24, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–18198 Filed 10–30–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0184]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Investigational
Device Exemptions Reports and
Records
AGENCY:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance:
Food and Drug Administration,
Notice.
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 review and clearance under
the Paperwork Reduction Act of 1995.
VerDate Aug<31>2005
15:25 Oct 30, 2006
Jkt 211001
Fax written comments on the
collection of information by November
30, 2006.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
DATES:
SUPPLEMENTARY INFORMATION:
HHS.
cprice-sewell on PROD1PC66 with NOTICES
2,000
2,000
1 There
ACTION:
Total Hours
Investigational Device Exemptions
Reports and Records—21 CFR 812
(OMB Control Number 0910–0078)—
Extension
Section 520(g) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 360j(g)) establishes the statutory
authority to collect information
regarding investigational devices, and
establishes rules under which new
PO 00000
Frm 00016
Fmt 4703
Sfmt 4703
medical devices may be tested using
human subjects in a clinical setting. The
Food and Drug Administration
Modernization Act of 1997 added
section 520(g)(6) to the act and
permitted changes to be made to either
the investigational device or to the
clinical protocol without FDA approval
of an investigational device exemption
(IDE) supplement.
An IDE allows a device, which would
otherwise be subject to provisions of the
act, such as premarket notification or
premarket approval, to be used in
investigations involving human subjects
in which the safety and effectiveness of
the device is being studied. The purpose
of part 812 (21 CFR part 812) is to
encourage, to the extent consistent with
the protection of public health and
safety and with ethical standards, the
discovery and development of useful
devices intended for human use. The
IDE regulation is designed to encourage
the development of useful medical
devices, and allow investigators the
maximum freedom possible, without
jeopardizing the health and safety of the
public or violating ethical standards.
To do this, the regulation provides for
different levels of regulatory control
depending on the level of potential risk
the investigational device presents to
E:\FR\FM\31OCN1.SGM
31OCN1
63767
Federal Register / Vol. 71, No. 210 / Tuesday, October 31, 2006 / Notices
human subjects. Investigations of
significant risk devices, ones that
present a potential for serious harm to
the rights, safety, or welfare of human
subjects, are subject to the full
requirements of the IDE regulation.
Nonsignificant risk device
investigations, ones that do not present
a potential for serious harm, are subject
to the reduced burden of the abbreviated
requirements.
The regulation also includes
provisions for treatment IDEs. The
purpose of these provisions is to
facilitate the availability, as early in the
device development process as possible,
of promising new devices to patients
with life-threatening or serious
conditions for which no comparable or
satisfactory alternative therapy is
available.
Section 812.10 allows the sponsor of
the IDE to request a waiver to all of the
requirements of part 812. This
information is needed for FDA to
determine if waiver of the requirements
of part 812 will impact the public’s
health and safety.
Sections 812.20, 812.25, and 812.27
consist of the information necessary to
file an IDE application with FDA. The
submission of an IDE application to
FDA is required only for significant risk
device investigations. Section 812.20
lists the data requirements for the
original IDE application; § 812.25 lists
the contents of the investigational plan;
and § 812.27 lists the data relating to
previous investigations or testing. The
information in this original IDE
application is evaluated by the Center
for Devices and Radiological Health to
determine whether the proposed
investigation will reasonably protect the
public health and safety, and for FDA to
make a determination to approve the
IDE.
Once FDA approves an IDE
application, a sponsor must submit
certain requests and reports. Under
§ 812.35, a sponsor who wishes to make
a change in the investigation which
affects the scientific soundness of the
study or the rights, safety, or welfare of
the subjects is required to submit a
request for the change to FDA. Under
§ 812.150, a sponsor is required to
submit reports to FDA. These requests
and reports are submitted to FDA as
supplemental applications. This
information is needed for FDA to assure
protection of human subjects and to
allow review of the study’s progress.
Section 812.36(c) identifies the
information necessary to file a treatment
IDE application. FDA uses this
information to determine if wider
distribution of the device is in the
interests of the public health. Section
812.36(f) identifies the reports required
to allow FDA to monitor the size and
scope of the treatment IDE, to assess the
sponsor’s due diligence in obtaining
marketing clearance of the device and to
ensure the integrity of the controlled
clinical trials.
Section 812.140 lists the
recordkeeping requirements for
investigators and sponsors. FDA
requires this information for tracking
and oversight purposes. Investigators
are required to maintain records,
including correspondence and reports
concerning the study; records of receipt,
use, or disposition of devices; records of
each subject’s case history and exposure
to the device; informed consent
documentation; study protocol and
documentation of any deviation from
the protocol. Sponsors are required to
maintain records including
correspondence and reports concerning
the study; records of shipment and
disposition; signed investigator
agreements; adverse device effects
information; and, for a nonsignificant
risk device study, an explanation of the
nonsignificant risk determination,
records on device name and intended
use, study objectives, investigator
information, investigational review
board (IRB) information, and statement
on the extent that good manufacturing
practices will be followed.
The most likely respondents to this
information collection will primarily be
medical device manufacturers,
investigators, hospitals, health
maintenance organizations, and
businesses.
In the Federal Register of May 26,
2006 (71 FR 30425), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
812.10
Annual Frequency
per Response
1
Total Annual
Responses
1
Hours per
Response
Total Hours
1
1
1
812.20, 812.25, and 812.27
600
0.5
275
80
22,000
812.35 and 812.150 (reports for significant risk studies)
600
7.8
4,700
6
28,200
812.150 (reports for nonsignificant risk
studies)
600
0.017
10
6
60
812.36(c)
1
1
1
120
120
812.36(f)
1
2
2
20
40
Total
1 There
50,421
are no capital costs or operating and maintenance costs associated with this collection of information.
cprice-sewell on PROD1PC66 with NOTICES
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
21 CFR Section
Annual Frequency
of Recordkeeping
812.140 Original
600
0.5
812.140 Supplemental
600
7
VerDate Aug<31>2005
15:25 Oct 30, 2006
Jkt 211001
PO 00000
Frm 00017
Fmt 4703
Sfmt 4703
Total Annual
Records
Hours per
Recordkeeper
Total Hours
275
10
2,750
4,700
1
4,700
E:\FR\FM\31OCN1.SGM
31OCN1
63768
Federal Register / Vol. 71, No. 210 / Tuesday, October 31, 2006 / Notices
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued
No. of
Recordkeepers
21 CFR Section
812.140 Nonsignificant
Annual Frequency
of Recordkeeping
600
Total Annual
Records
1
Hours per
Recordkeeper
600
6
Total
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 24, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–18200 Filed 10–30–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0239]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Infectious Disease
Issues in Xenotransplantation
AGENCY:
Food and Drug Administration,
HHS.
Notice.
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 review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by November
30, 2006.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
cprice-sewell on PROD1PC66 with NOTICES
3,600
11,050
1 There
ACTION:
Total Hours
Infectious Disease Issues in
Xenotransplantation—(OMB Control
Number 0910–0456)—Extension
The statutory authority to collect this
information is provided under sections
VerDate Aug<31>2005
15:25 Oct 30, 2006
Jkt 211001
351 and 361 of the Public Health
Service (PHS) act (42 U.S.C. 262 and
264) and the provisions of the Federal
Food, Drug, and Cosmetic Act that
apply to drugs (21 U.S.C. 301 et seq.).
The PHS guideline recommends
procedures to diminish the risk of
transmission of infectious agents to the
xenotransplantation product recipient
and the general public. The PHS
guideline is intended to address public
health issues raised by
xenotransplantation, through
identification of general principles of
prevention and control of infectious
diseases associated with
xenotransplantation that may pose a
hazard to the public health. The
collection of information described in
this guideline is intended to provide
general guidance to sponsors in the
following ways: (1) The development of
xenotransplantation clinical protocols,
(2) the preparation of submissions to
FDA, and (3) the conduct of
xenotransplantation clinical trials. Also,
the collection of information will help
ensure that the sponsor maintains
important information in a crossreferenced system that links the relevant
records of the xenotransplantation
product recipient, xenotransplantation
product, source animal(s), animal
procurement center, and significant
nosocomial exposures. The PHS
guideline describes an occupational
health service program for the
protection of health care workers
involved in xenotransplantation
procedures, caring for
xenotransplantation product recipients,
and performing associated laboratory
testing. The guideline also describes a
public health need for a national
xenotransplantation database, which is
currently under development by PHS.
The PHS guideline is intended to
protect the public health and to help
ensure the safety of using
xenotransplantation products in
humans by preventing the introduction,
transmission, and spread of infectious
diseases associated with
xenotransplantation.
The PHS guideline also recommends
that certain specimens and records be
maintained for 50 years beyond the date
of the xenotransplantation. These
PO 00000
Frm 00018
Fmt 4703
Sfmt 4703
include the following information, as
recommended by the specific PHS
guideline sections: (1) Records linking
each xenotransplantation product
recipient with relevant health records of
the source animal, herd, or colony, and
the specific organ, tissue, or cell type
included in or used in the manufacture
of the product (3.2.7.1); (2) aliquots of
serum samples from randomly selected
animal and specific disease
investigations (3.4.3.1); (3) source
animal biological specimens designated
for PHS use (3.7.1); animal health
records (3.7.2), including necropsy
results (3.6.4); and (4) recipients’
biological specimens (4.1.2). The
retention period is intended to assist
health care practitioners and officials in
surveillance and in tracking the source
of an infection, disease, or illness that
might emerge in the recipient, the
source animal, or the animal herd or
colony after a xenotransplantation.
The recommendation for maintaining
records for 50 years is based on clinical
experience with several human viruses
that have presented problems in human
to human transplantation and are
therefore thought to share certain
characteristics with viruses that may
pose potential risks in
xenotransplantation. These
characteristics include long latency
periods and the ability to establish
persistent infections. Several also share
the possibility of transmission among
individuals through intimate contact
with human body fluids. Human
immunodeficiency virus (HIV) and
Human T-lymphotropic virus are
human retroviruses. Retroviruses
contain ribonucleic acid (RNA) that is
reverse-transcribed into
deoxyribonucleic acid (DNA) using an
enzyme provided by the virus and the
human cell machinery. That viral DNA
can then be integrated into the human
cellular DNA. Both viruses establish
persistent infections and have long
latency periods before the onset of
disease, 10 years and 40 to 60 years,
respectively. The human hepatitis
viruses are not retroviruses, but several
share with HIV the characteristic that
they can be transmitted through body
fluids, can establish persistent
infections, and have long latency
E:\FR\FM\31OCN1.SGM
31OCN1
]]>Agencies
[Federal Register Volume 71, Number 210 (Tuesday, October 31, 2006)]
[Notices]
[Pages 63766-63768]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-18200]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0184]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Investigational
Device Exemptions Reports and Records
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
November 30, 2006.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1472.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance:
Investigational Device Exemptions Reports and Records--21 CFR 812 (OMB
Control Number 0910-0078)--Extension
Section 520(g) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 360j(g)) establishes the statutory authority to collect
information regarding investigational devices, and establishes rules
under which new medical devices may be tested using human subjects in a
clinical setting. The Food and Drug Administration Modernization Act of
1997 added section 520(g)(6) to the act and permitted changes to be
made to either the investigational device or to the clinical protocol
without FDA approval of an investigational device exemption (IDE)
supplement.
An IDE allows a device, which would otherwise be subject to
provisions of the act, such as premarket notification or premarket
approval, to be used in investigations involving human subjects in
which the safety and effectiveness of the device is being studied. The
purpose of part 812 (21 CFR part 812) is to encourage, to the extent
consistent with the protection of public health and safety and with
ethical standards, the discovery and development of useful devices
intended for human use. The IDE regulation is designed to encourage the
development of useful medical devices, and allow investigators the
maximum freedom possible, without jeopardizing the health and safety of
the public or violating ethical standards.
To do this, the regulation provides for different levels of
regulatory control depending on the level of potential risk the
investigational device presents to
[[Page 63767]]
human subjects. Investigations of significant risk devices, ones that
present a potential for serious harm to the rights, safety, or welfare
of human subjects, are subject to the full requirements of the IDE
regulation. Nonsignificant risk device investigations, ones that do not
present a potential for serious harm, are subject to the reduced burden
of the abbreviated requirements.
The regulation also includes provisions for treatment IDEs. The
purpose of these provisions is to facilitate the availability, as early
in the device development process as possible, of promising new devices
to patients with life-threatening or serious conditions for which no
comparable or satisfactory alternative therapy is available.
Section 812.10 allows the sponsor of the IDE to request a waiver to
all of the requirements of part 812. This information is needed for FDA
to determine if waiver of the requirements of part 812 will impact the
public's health and safety.
Sections 812.20, 812.25, and 812.27 consist of the information
necessary to file an IDE application with FDA. The submission of an IDE
application to FDA is required only for significant risk device
investigations. Section 812.20 lists the data requirements for the
original IDE application; Sec. 812.25 lists the contents of the
investigational plan; and Sec. 812.27 lists the data relating to
previous investigations or testing. The information in this original
IDE application is evaluated by the Center for Devices and Radiological
Health to determine whether the proposed investigation will reasonably
protect the public health and safety, and for FDA to make a
determination to approve the IDE.
Once FDA approves an IDE application, a sponsor must submit certain
requests and reports. Under Sec. 812.35, a sponsor who wishes to make
a change in the investigation which affects the scientific soundness of
the study or the rights, safety, or welfare of the subjects is required
to submit a request for the change to FDA. Under Sec. 812.150, a
sponsor is required to submit reports to FDA. These requests and
reports are submitted to FDA as supplemental applications. This
information is needed for FDA to assure protection of human subjects
and to allow review of the study's progress.
Section 812.36(c) identifies the information necessary to file a
treatment IDE application. FDA uses this information to determine if
wider distribution of the device is in the interests of the public
health. Section 812.36(f) identifies the reports required to allow FDA
to monitor the size and scope of the treatment IDE, to assess the
sponsor's due diligence in obtaining marketing clearance of the device
and to ensure the integrity of the controlled clinical trials.
Section 812.140 lists the recordkeeping requirements for
investigators and sponsors. FDA requires this information for tracking
and oversight purposes. Investigators are required to maintain records,
including correspondence and reports concerning the study; records of
receipt, use, or disposition of devices; records of each subject's case
history and exposure to the device; informed consent documentation;
study protocol and documentation of any deviation from the protocol.
Sponsors are required to maintain records including correspondence and
reports concerning the study; records of shipment and disposition;
signed investigator agreements; adverse device effects information;
and, for a nonsignificant risk device study, an explanation of the
nonsignificant risk determination, records on device name and intended
use, study objectives, investigator information, investigational review
board (IRB) information, and statement on the extent that good
manufacturing practices will be followed.
The most likely respondents to this information collection will
primarily be medical device manufacturers, investigators, hospitals,
health maintenance organizations, and businesses.
In the Federal Register of May 26, 2006 (71 FR 30425), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
812.10 1 1 1 1 1
----------------------------------------------------------------------------------------------------------------
812.20, 812.25, 600 0.5 275 80 22,000
and 812.27
----------------------------------------------------------------------------------------------------------------
812.35 and 600 7.8 4,700 6 28,200
812.150 (reports
for significant
risk studies)
----------------------------------------------------------------------------------------------------------------
812.150 (reports 600 0.017 10 6 60
for
nonsignificant
risk studies)
----------------------------------------------------------------------------------------------------------------
812.36(c) 1 1 1 120 120
----------------------------------------------------------------------------------------------------------------
812.36(f) 1 2 2 20 40
----------------------------------------------------------------------------------------------------------------
Total 50,421
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Recordkeepers of Recordkeeping Records Recordkeeper Total Hours
----------------------------------------------------------------------------------------------------------------
812.140 Original 600 0.5 275 10 2,750
----------------------------------------------------------------------------------------------------------------
812.140 600 7 4,700 1 4,700
Supplemental
----------------------------------------------------------------------------------------------------------------
[[Page 63768]]
812.140 600 1 600 6 3,600
Nonsignificant
----------------------------------------------------------------------------------------------------------------
Total 11,050
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: October 24, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-18200 Filed 10-30-06; 8:45 am]
BILLING CODE 4160-01-S
