Agency Information Collection Activities; Proposed Collection; Comment Request; Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002, 50067-50068 [E6-14056]
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50067
Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Notices
Dated: August 14, 2006.
Sally D. Atwater,
Executive Director, President’s Committee for
People with Intellectual Disabilities.
[FR Doc. E6–13996 Filed 8–23–06; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0326]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Inspection by
Accredited Persons Program Under
the Medical Device User Fee and
Modernization Act of 2002
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the publication of the criteria FDA
intends to use to accredit third parties
to conduct inspections of eligible
manufacturers of class II or class III
medical devices.
DATES: Submit written or electronic
comments on the collection of
information by October 23, 2006.
Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of
Management Programs (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
ADDRESSES:
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
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.
Medical Devices: Inspection by
Accredited Persons Program Under
MDUFMA (OMB Control Number 0910–
0510)—Extension
The Medical Device User Fee and
Modernization Act of 2002 (MDUFMA)
(Public Law 107–250) was signed into
law on October 26, 2002. Section 201 of
MDUFMA adds a new paragraph ‘‘g’’ to
section 704 of the Federal, Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
374), directing FDA to accredit third
parties (accredited persons or APs) to
conduct inspections of eligible
manufacturers of class II or class III
devices. This is a voluntary program.
FDA has a guidance document that
provides information for those
interested in participating in this
program. The guidance is entitled
‘‘Implementation of the Inspection by
Accredited Persons Program Under the
Medical Device User Fee and
Modernization Act of 2002;
Accreditation Criteria.’’
Description of Respondents:
Businesses or other for profit
organizations.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Information Collection:
No. of
Respondents
Request for Accreditation
Annual Frequency
per Response
3
Total Annual
Responses
1
Hours per
Response
3
80
Total Hours
rmajette on PROD1PC67 with NOTICES1
1There
240
240
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Aug<31>2005
Total Hours
15:15 Aug 23, 2006
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50068
Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Notices
FDA based these estimates on
conversations with industry, trade
association representatives, and internal
FDA estimates. Once an organization is
accredited, it will not be required to
reapply.
Dated: August 18, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–14056 Filed 8–23–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food Safety and Security Monitoring
Project—Radiological Health;
Announcement Type: Cooperative
Agreements Under a Limited
Competition; Funding Opportunity
Number: Request for Applications:
RFA–FDA–ORA–2006–4; Catalog of
Federal Domestic Assistance Number:
93.448
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
rmajette on PROD1PC67 with NOTICES1
I. Funding Opportunity Description
The Food and Drug Administration
(FDA), Office of Regulatory Affairs
(ORA), Division of Federal-State
Relations (DFSR), is announcing the
availability of cooperative agreements
for equipment, supplies, personnel,
training, and facility upgrades to Food
Emergency Response Laboratory
Network (FERN) radiological
laboratories of State, local, and tribal
governments. The cooperative
agreements are to enable the analyses of
foods and food products in the event
that redundancy and/or additional
laboratory surge capacity is needed by
FERN for analyses related to
radiological terrorism or other
emergency situation. These cooperative
agreements are also intended to expand
participation in networks to enhance
Federal, State, local, and tribal
governmental food safety and security
efforts.
The goal of ORA’s cooperative
agreement program is to complement
and improve State, local and Indian
tribal governmental food safety and
security testing programs. This will be
accomplished through the provision of
supplies, personnel, facility upgrades,
training in current food testing
methodologies, participation in
proficiency testing to establish
additional reliable laboratory sample
analysis capacity, participation in
VerDate Aug<31>2005
15:15 Aug 23, 2006
Jkt 208001
method enhancement activities to
extend analysis capability, and analysis
of surveillance samples. In the event of
a large-scale radiological terrorism event
affecting foods or food products, the
recipient may be required to perform
selected radiological analyses of
domestic and imported food samples
collected and supplied to the laboratory
by FDA or other Federal agencies
through FDA. These samples may
consist of, but are not limited to, the
following: vegetables and fruits (fresh
and packaged); juices (concentrate and
diluted); grains and grain products;
seafood and other fish products; milk
and other dairy products; infant
formula; baby foods; bottled water;
condiments; and alcoholic beverage
products.
All grant application projects that are
developed at State, local, and tribal
governmental levels must have national
application that can enhance Federal
food safety and security programs. At
the discretion of the FDA, successful
project formats will be made available to
interested Federal, State, local and tribal
government FERN laboratories.
There are two key project areas
identified for this effort:
(1) The use of Gamma Spectrometry
analysis for the screening and
identification of gamma emitting
radionuclides in foods; and
(2) The use of Beta Spectrometry
analysis for the screening and
identification of beta emitting
radionuclides in foods.
FDA will support the projects covered
by this notice under the authority of
section 312 of the Public Health
Security and Bioterrorism Preparedness
and Response Act of 2002 (the
Bioterrorism Act) (Public Law 107–188).
This program is described in the Catalog
of Federal Domestic Assistance under
93.448.
1. Background
ORA is the primary inspection and
analysis component of FDA/ORA has
approximately 1,600 investigators,
inspectors, and analysts who cover the
country’s approximately 95,000 FDA
regulated businesses. These
investigators inspect more that 15,000
facilities a year; and ORA laboratories
analyze several thousand samples per
year. ORA conducts special
investigations, food inspection recall
audits, performs consumer complaint
inspections, and collects samples of
regulated products. Increasingly, ORA
has been called upon to expand the
testing program to address the
increasing threat to food safety and
security through intentional radiological
terrorism events. ORA developed
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Frm 00043
Fmt 4703
Sfmt 4703
radiological screening and analysis
methodologies that are used to evaluate
foods and food products in such
situations. However, in the event of a
large-scale emergent incident, analytical
sample capacity in ORA field
laboratories has a finite limit.
Information from ongoing relationships
with state partners indicates limited
redundancy in state food testing
laboratories, both in terms of analytical
capabilities and analytical sample
capacity. Several state food testing
laboratories lack the specialized
equipment to perform the analyses and/
or the specific methodological expertise
in the types of analyses performed for
screening foods and food products
involving radiological terrorism events.
Subtitle A of Title III of the
Bioterrorism Act, Protection of Food
Supply, section 312-Surveillance and
Information Grants and Authorities,
amends part B of Title III of the Public
Health Service Act to authorize the
Secretary of Health and Human Services
(the Secretary) to award grants to States
and Indian tribes to expand
participation in networks to enhance
Federal, State, and local food safety
efforts. This may include meeting the
costs of establishing and maintaining
the food safety surveillance, technical,
and laboratory capacity needed for such
participation.
2. Program Research Goals
The goal of ORA’s cooperative
agreement program is to complement
and improve State, local and Indian
tribal food safety and security testing
programs. This will be accomplished
through the provision of equipment,
supplies, personnel, facility upgrades,
training in current food testing
methodologies, participation in
proficiency testing to establish
additional reliable laboratory sample
analysis capacity, analysis of
surveillance samples, and in
cooperation with FDA, participation in
method enhancement activities
designed to extend analytical
capabilities. In the event of a large-scale
radiological terrorism event affecting
foods or food products, the recipient
may be required to perform selected
radiological analyses of domestic and
imported food samples collected and
supplied to the laboratory by FDA or
other Federal agencies through FDA.
These samples may consist of, but are
not limited to, the following: vegetables
and fruits (fresh and packaged); juices
(concentrate and diluted); grains and
grain products; seafood and other fish
products; milk and other dairy products;
infant formula; baby foods; bottled
E:\FR\FM\24AUN1.SGM
24AUN1
]]>Agencies
[Federal Register Volume 71, Number 164 (Thursday, August 24, 2006)]
[Notices]
[Pages 50067-50068]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-14056]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0326]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Inspection by Accredited Persons Program Under the
Medical Device User Fee and Modernization Act of 2002
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the publication of the
criteria FDA intends to use to accredit third parties to conduct
inspections of eligible manufacturers of class II or class III medical
devices.
DATES: Submit written or electronic comments on the collection of
information by October 23, 2006.
ADDRESSES: Submit electronic comments on the collection of information
to: https://www.fda.gov/dockets/ecomments. Submit written comments on
the collection of information to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Management Programs (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1472.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance 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.
Medical Devices: Inspection by Accredited Persons Program Under MDUFMA
(OMB Control Number 0910-0510)--Extension
The Medical Device User Fee and Modernization Act of 2002 (MDUFMA)
(Public Law 107-250) was signed into law on October 26, 2002. Section
201 of MDUFMA adds a new paragraph ``g'' to section 704 of the Federal,
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 374), directing FDA
to accredit third parties (accredited persons or APs) to conduct
inspections of eligible manufacturers of class II or class III devices.
This is a voluntary program.
FDA has a guidance document that provides information for those
interested in participating in this program. The guidance is entitled
``Implementation of the Inspection by Accredited Persons Program Under
the Medical Device User Fee and Modernization Act of 2002;
Accreditation Criteria.''
Description of Respondents: Businesses or other for profit
organizations.
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
Information Collection: Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Request for Accreditation 3 1 3 80 240
---------------------------------------------------------------------------------------------------------------------------------------
Total Hours ................. .................... ................. ................. 240
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 50068]]
FDA based these estimates on conversations with industry, trade
association representatives, and internal FDA estimates. Once an
organization is accredited, it will not be required to reapply.
Dated: August 18, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-14056 Filed 8-23-06; 8:45 am]
BILLING CODE 4160-01-S
