National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting, 50977 [E8-19916]
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Federal Register / Vol. 73, No. 169 / Friday, August 29, 2008 / Notices
Requests for Inspection Under the
Inspection by Accredited Persons
Program--21 U.S.C. 374(g) (OMB
Control Number 0910–0569)—Extension
Section 201 of the Medical Device
User Fee and Modernization Act of
2002, (Public Law 107–250), amended
section 704 of the Federal Food, Drug,
and Cosmetic Act by adding subsection
(g) (21 U.S.C. 374 (g)). This amendment
authorized FDA to establish a voluntary
third party inspection program
applicable to manufacturers of class II or
class III medical devices who meet
certain eligibility criteria. On September
15, 2005, FDA issued a guidance
entitled, ‘‘Requests for Inspection by an
Accredited Person Under the Inspection
by Accredited Persons Program
Authorized by Section 201 of the
Medical Device User Fee and
Modernization Act 2002,’’ https://
www.fda.gov/cdrh/comp/guidance/
1532.html. This guidance describes the
eligibility criteria and the process for
establishments to follow when
requesting FDA’s approval to have an
accredited person (AP), conduct a
quality system regulation inspection of
their establishment under the new
inspection by the Accredited Persons
Program (AP program), instead of FDA.
The AP program applies to
manufacturers who currently market
their medical devices in the United
States and who also market or plan to
market their devices in foreign
countries. Such manufacturers may
need current inspections of their
establishments to operate in global
commerce.
In order to meet the eligibility criteria
for requesting FDA approval to have an
AP conduct a quality system regulations
inspection of their establishment
instead of FDA, applicants must submit
a request with certain information. The
following information must be
submitted which shows that the
applicant:
(1) ‘‘Manufactures, prepares,
propagates, compounds, or processes’’
class II or class III medical devices,
(2) Markets at least one of the devices
in the United States,
(3) Markets or intends to market at
least one of the devices in one or more
50977
foreign countries when one or both of
the following two conditions are met:
(a) One of the foreign countries
certifies, accredits, or otherwise
recognizes the selected AP applicant as
a person authorized to conduct
inspections of device establishments, or
(b) A statement that the law of a
country where the applicant markets or
intends to market the device recognizes
an inspection conducted by the FDA or
an AP.
(4) Provided the most recent
inspection performed by FDA, or by an
AP under the AP program and
inspection was classified by FDA as
either ‘‘No Action Indicated’’ or
‘‘Voluntary Action Indicated, ‘‘and,
(5) Provided notice advising FDA of
their intent to use an AP, and
identifying the AP applicant selected.
In the Federal Register of June 3, 2008
(73 FR 31692), FDA published a 60-day
notice requesting public comment on
the information collection provisions.
No comments were received.
FDA estimates the burden for this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 U.S.C. Section
374(g)
1 There
Annual Frequency per
Response
No. of Respondents
100
1
Hours per
Response
100
Total Hours
15
1,500
are no capital costs or operating and maintenance costs associated with this collection of information.
There are approximately 8,000 foreign
and 10,000 domestic manufacturers of
medical devices. Approximately 5,000
of these firms only manufacture class I
devices and are, therefore, not eligible
for the AP program. In addition, 40
percent of the domestic firms do not
export devices and therefore are not
eligible to participate in the AP
program. Further, 10 to 15 percent of the
firms are not eligible due to the results
of their previous inspection. FDA
estimates there are 4,000 domestic
manufacturers and 4,000 foreign
manufacturers that are eligible for
inclusion under the AP program. Based
on communications with industry, FDA
estimates that on an annual basis
approximately 100 of these
manufacturers may submit a request to
use an AP in any given year.
mstockstill on PROD1PC66 with NOTICES
Total Annual
Responses
Dated: August 25, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–20113 Filed 8–28–08; 8:45 am]
17:32 Aug 28, 2008
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. Appendix 2), 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.
Emphasis Panel; Category A and B
Pathogens.
Date: September 18, 2008.
Time: 12 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6700B
Rockledge Drive, Bethesda, MD 20817,
(Telephone Conference Call).
Contact Person: Lucy A. Ward, DVM, PhD,
Scientific Review Officer, Scientific Review
Program, Division of Extramual Activities,
NIAID/NIH/DHHS, 6700B Rockledge Drive,
MSC 7616, Bethesda, MD 20892, 301–594–
6635, lward@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: August 21, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–19916 Filed 8–28–08; 8:45 am]
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Name of Committee: National Institute of
Allergy and Infectious Diseases Special
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[Federal Register Volume 73, Number 169 (Friday, August 29, 2008)]
[Notices]
[Page 50977]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-19916]
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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. Appendix 2), 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; Category A and B Pathogens.
Date: September 18, 2008.
Time: 12 p.m. to 3 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6700B Rockledge Drive,
Bethesda, MD 20817, (Telephone Conference Call).
Contact Person: Lucy A. Ward, DVM, PhD, Scientific Review
Officer, Scientific Review Program, Division of Extramual
Activities, NIAID/NIH/DHHS, 6700B Rockledge Drive, MSC 7616,
Bethesda, MD 20892, 301-594-6635, lward@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.855,
Allergy, Immunology, and Transplantation Research; 93.856,
Microbiology and Infectious Diseases Research, National Institutes
of Health, HHS)
Dated: August 21, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E8-19916 Filed 8-28-08; 8:45 am]
BILLING CODE 4140-01-M
