Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Studies-Frequently Asked Questions; Availability, 36425-36426 [2010-15417]
Download as PDF
Federal Register / Vol. 75, No. 122 / Friday, June 25, 2010 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0076] (formerly
Docket No. 2007D–0387)
Guidance for Industry and Food and
Drug Administration Staff; In Vitro
Diagnostic Studies—Frequently Asked
Questions; Availability
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSKH9S0YB1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the guidance entitled ‘‘In
Vitro Diagnostic (IVD) Device Studies—
Frequently Asked Questions.’’ FDA is
issuing this guidance to assist
manufacturers in developing and
conducting studies for IVD devices,
particularly those exempt from most of
the Investigational Device Exemption
(IDE) regulations. The guidance explains
data considerations that ultimately will
affect the quality of the premarket
submission. The draft of this guidance
was issued October 25, 2007.
DATES: Submit either electronic or
written comments on this guidance at
any time. General comments on agency
guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for
single copies of the guidance document
entitled ‘‘ In Vitro Diagnostic (IVD)
Device Studies—Frequently Asked
Questions’’ to the Division of Small
Manufacturers, International, and
Consumer Assistance, Center for
Devices and Radiological Health
(CDRH), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
rm. 4613, Silver Spring, MD 20993–
0002, or to the Office of
Communication, Outreach and
Development (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 301–847–
8149. 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 electronic comments on the
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,
VerDate Mar<15>2010
16:23 Jun 24, 2010
Jkt 220001
MD 20852. Identify comments with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Sally Hojvat, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 5524, Silver Spring,
MD 20993–0002, 301–796–5455; or
Stephen Ripley, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
This guidance facilitates the
movement of new IVD technology from
the investigational stage to the
marketing stage by providing
information about the development and
conduct of IVD studies that will be
submitted to the agency to support
premarket notifications and
applications. Because many IVD studies
are exempt from most of the IDE
regulations at part 812 (21 CFR part 812)
(§ 812.2(c)(3)), industry sponsors and
FDA staff often have questions
concerning the relevant requirements
and appropriate methods for such
studies. This guidance provides
information about such studies as well
as general information about the
development, conduct, and
responsibilities associated with all IVD
studies. CDRH and CBER both have
regulatory oversight of IVD devices.
Information in this guidance is relevant
to IVD devices regulated by either center
under chapter I of title 21 of the Code
of Federal Regulations, subchapter H.
In the Federal Register of October 25,
2007 (72 FR 60682), FDA announced the
availability of the draft guidance. FDA
received one comment regarding the use
of investigational IVD devices in clinical
drug trials. The comment addresses
issues outside the scope of this guidance
because this guidance makes
recommendations for studies to support
premarket notifications and approvals of
IVD devices and does not address the
use of investigational devices in clinical
studies designed to evaluate new drug
products.
FDA made several minor wording
changes to the guidance document in
order to improve clarity, however there
are no significant, substantive changes.
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the agency’s
current thinking on ‘‘In Vitro Diagnostic
PO 00000
Frm 00080
Fmt 4703
Sfmt 4703
36425
(IVD) Device Studies—Frequently
Asked Questions.’’ 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 guidance may do so by using the
Internet. To receive ‘‘In Vitro Diagnostic
(IVD) Device Studies—Frequently
Asked Questions,’’ 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 301–
847–8149 to receive a hard copy. Please
use the document number 1587 to
identify the guidance you are
requesting.
A search capability for all CDRH
guidance documents is available at
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov or the
CBER Internet site at https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/default.htm.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information 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
part 807 (21 CFR part 807), subpart E,
including § 807.87, have been approved
under OMB control no. 0910–0120; the
collections of information in 21 CFR
part 860 have been approved under
OMB control no. 0910–0138; the
collections of information in 21 CFR
part 812 have been approved under
OMB control no. 0910–0078; the
collections of information in 21 CFR
parts 50 and 56 have been approved
under OMB control no. 0910–0130; the
collections of information in 21 CFR
part 803 have been approved under
OMB control no. 0910–0437; the
collections of information in 21 CFR
part 810 have been approved under
OMB control no. 0910–0432; the
collections of information in part 814
(21 CFR part 814), subparts B and E,
have been approved under OMB control
no. 0910–0231; the collections of
information in part 814, subpart H, have
been approved under OMB control no.
0910–0332; the collections of
information in 21 CFR part 820 have
E:\FR\FM\25JNN1.SGM
25JNN1
36426
Federal Register / Vol. 75, No. 122 / Friday, June 25, 2010 / Notices
been approved under OMB control no.
0910–0073; the collections of
information in 21 CFR part 610 have
been approved under OMB control nos.
0910–0116 and 0910–0338; and the
collections of information in 21 CFR
809.10 have been approved under OMB
control no. 0910–0485.
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: June 21, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–15417 Filed 6–24–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Legislative Changes to Nursing
Student Loan Program Authorized
Under Title VIII of the Public Health
Service Act
Health Resources and Services
Administration, HHS.
ACTION: Notice.
mstockstill on DSKH9S0YB1PROD with NOTICES
AGENCY:
SUMMARY: On March 23, 2010, President
Obama signed into law the Patient
Protection and Affordable Care Act
(ACA), Public Law (Pub. L.) 111–148.
Section 5202 of the ACA changes the
Nursing Student Loan (NSL) program
by: (1) Increasing the limits of loan
funds to students; (2) revising the date
of enrollment to be considered eligible
to receive NSL funds; and (3) revising
the date of loans eligible for partial loan
cancellation.
SUPPLEMENTARY INFORMATION: The
Nursing Student Loan (NSL) program
was authorized by the Nurse Training
Act of 1964 (Pub. L. 88–581) to alleviate
the shortage of nursing personnel and to
assure that no qualified student was
denied the pursuit of a nursing career
due to lack of financial resources. The
NSL program provides long-term, lowinterest loans to full-time and half-time
students to help meet the cost of
education. Students are eligible to apply
VerDate Mar<15>2010
16:23 Jun 24, 2010
Jkt 220001
for the NSL program if pursuing a
course of study leading to a diploma in
nursing, an associate or bachelor’s
degree in nursing or an equivalent
degree, or a graduate degree in nursing.
Below are details on how the ACA
changes Sections 836(a), 836(b)(1), and
836(b)(3) of the Public Health Service
Act, respectively, regarding the
administration of the NSL program.
Loan Funding Limits
The ACA increases the maximum
amount of NSL funding a student can
receive. Previously, the total amount of
NSL funds for any academic year could
not exceed $2,500 in the case of any
student except that, for the final 2
academic years of the program involved,
such total could not exceed $4,000.
With the legislative change, however,
the new total amount of the loans for
any academic year from NSL funds may
not exceed $3,300 in the case of any
student except that, for the final two
academic years of the program involved,
such total may not exceed $5,200.
Prior to the ACA, the aggregate of the
NSL loans for all years from such funds
was a maximum of $13,000 in the case
of any student. Now, the aggregate of the
loans for all years from such funds may
not exceed $17,000 in the case of any
student during fiscal years 2010 and
2011. After fiscal year 2011, the
amounts shall be adjusted to provide for
a cost-of-attendance increase for the
yearly loan rate and the aggregate of the
loans. (Section 5202(a) of the ACA.)
Date of Enrollment
The ACA changes the date a student
of financial need must be enrolled in a
nursing program in order to be eligible
to receive NSL funds. Previously an
NSL loan could be made to a student of
financial need who was enrolled after
June 30, 1986. Now, an NSL loan can be
made to a student of financial need who
was enrolled after June 30, 2000.
(Section 5202(b)(1) of the ACA.)
To be eligible, students are still also
required to: (1) Pursue a full-time or
half-time course of study at the school
leading to a baccalaureate or associate
degree in nursing or an equivalent
degree, or a diploma in nursing, or a
graduate degree in nursing and (2) be
capable, in the opinion of the school, of
maintaining good standing in such
course of study.
Partial Loan Cancellation Date
Prior to the ACA, students who
received NSL loans before September
29, 1979, could receive partial
cancellation of their loans. Now,
however, partial loan cancellation
applies to loans received by students
PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
before September 29, 1995. (Section
5202(b)(2) of the ACA.)
A student who received such an NSL
before September 29, 1995, can have an
amount up to 85 percent of that nursing
student loan (plus interest thereon)
cancelled for full-time employment as a
professional nurse in any public or nonprofit private agency, institution, or
organization, at the rate of 15 percent of
the amount of such loan (plus interest)
unpaid on the first day of such service
for each of the first, second, and third
complete year of such service, and 20
percent of such amount (plus interest)
for each complete fourth and fifth year
of such service. Employment as a
professional nurse may include teaching
in any of the fields of nurse training and
serving as an administrator, supervisor,
or consultant in any of the fields of
nursing. Nursing experience prior to
March 23, 2010 will not be considered
in determining loan cancellation.
Dated: June 21, 2010.
Mary K. Wakefield,
Administrator.
[FR Doc. 2010–15421 Filed 6–24–10; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel, Host-Pathogen Interactions.
Date: August 2, 2010.
Time: 9 a.m. to 2 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6700B
Rockledge Drive, Bethesda, MD 20817.
Contact Person: Lynn Rust, PhD, Scientific
Review Officer, Scientific Review Program,
Division of Extramural Activities, NIAID/
NIH/DHHS, Room 3120, 6700B Rockledge
E:\FR\FM\25JNN1.SGM
25JNN1
Agencies
[Federal Register Volume 75, Number 122 (Friday, June 25, 2010)]
[Notices]
[Pages 36425-36426]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-15417]
[[Page 36425]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-D-0076] (formerly Docket No. 2007D-0387)
Guidance for Industry and Food and Drug Administration Staff; In
Vitro Diagnostic Studies--Frequently Asked Questions; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``In Vitro Diagnostic (IVD)
Device Studies--Frequently Asked Questions.'' FDA is issuing this
guidance to assist manufacturers in developing and conducting studies
for IVD devices, particularly those exempt from most of the
Investigational Device Exemption (IDE) regulations. The guidance
explains data considerations that ultimately will affect the quality of
the premarket submission. The draft of this guidance was issued October
25, 2007.
DATES: Submit either electronic or written comments on this guidance
at any time. General comments on agency guidance documents are welcome
at any time.
ADDRESSES: Submit written requests for single copies of the guidance
document entitled `` In Vitro Diagnostic (IVD) Device Studies--
Frequently Asked Questions'' to the Division of Small Manufacturers,
International, and Consumer Assistance, Center for Devices and
Radiological Health (CDRH), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002, or to
the Office of Communication, Outreach and Development (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 301-847-8149.
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 electronic comments on the 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: Sally Hojvat, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 5524, Silver Spring, MD 20993-0002, 301-796-5455;
or
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-
17), Food and Drug Administration, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852-1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
This guidance facilitates the movement of new IVD technology from
the investigational stage to the marketing stage by providing
information about the development and conduct of IVD studies that will
be submitted to the agency to support premarket notifications and
applications. Because many IVD studies are exempt from most of the IDE
regulations at part 812 (21 CFR part 812) (Sec. 812.2(c)(3)), industry
sponsors and FDA staff often have questions concerning the relevant
requirements and appropriate methods for such studies. This guidance
provides information about such studies as well as general information
about the development, conduct, and responsibilities associated with
all IVD studies. CDRH and CBER both have regulatory oversight of IVD
devices. Information in this guidance is relevant to IVD devices
regulated by either center under chapter I of title 21 of the Code of
Federal Regulations, subchapter H.
In the Federal Register of October 25, 2007 (72 FR 60682), FDA
announced the availability of the draft guidance. FDA received one
comment regarding the use of investigational IVD devices in clinical
drug trials. The comment addresses issues outside the scope of this
guidance because this guidance makes recommendations for studies to
support premarket notifications and approvals of IVD devices and does
not address the use of investigational devices in clinical studies
designed to evaluate new drug products.
FDA made several minor wording changes to the guidance document in
order to improve clarity, however there are no significant, substantive
changes.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on ``In Vitro Diagnostic (IVD) Device
Studies--Frequently Asked Questions.'' 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 guidance may do so by
using the Internet. To receive ``In Vitro Diagnostic (IVD) Device
Studies--Frequently Asked Questions,'' 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 301-847-8149 to receive a hard copy.
Please use the document number 1587 to identify the guidance you are
requesting.
A search capability for all CDRH guidance documents is available at
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at
https://www.regulations.gov or the CBER Internet site at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
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 part 807 (21 CFR part 807), subpart E,
including Sec. 807.87, have been approved under OMB control no. 0910-
0120; the collections of information in 21 CFR part 860 have been
approved under OMB control no. 0910-0138; the collections of
information in 21 CFR part 812 have been approved under OMB control no.
0910-0078; the collections of information in 21 CFR parts 50 and 56
have been approved under OMB control no. 0910-0130; the collections of
information in 21 CFR part 803 have been approved under OMB control no.
0910-0437; the collections of information in 21 CFR part 810 have been
approved under OMB control no. 0910-0432; the collections of
information in part 814 (21 CFR part 814), subparts B and E, have been
approved under OMB control no. 0910-0231; the collections of
information in part 814, subpart H, have been approved under OMB
control no. 0910-0332; the collections of information in 21 CFR part
820 have
[[Page 36426]]
been approved under OMB control no. 0910-0073; the collections of
information in 21 CFR part 610 have been approved under OMB control
nos. 0910-0116 and 0910-0338; and the collections of information in 21
CFR 809.10 have been approved under OMB control no. 0910-0485.
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: June 21, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-15417 Filed 6-24-10; 8:45 am]
BILLING CODE 4160-01-S