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Federal Register / Vol. 71, No.

164 / Thursday, August 24, 2006 / Notices 50067

Dated: August 14, 2006. ADDRESSES: Submit electronic of FDA’s functions, including whether
Sally D. Atwater, comments on the collection of the information will have practical
Executive Director, President’s Committee for information to: http://www.fda.gov/ utility; (2) the accuracy of FDA’s
People with Intellectual Disabilities. dockets/ecomments. Submit written estimate of the burden of the proposed
[FR Doc. E6–13996 Filed 8–23–06; 8:45 am] comments on the collection of collection of information, including the
BILLING CODE 4184–01–P information to the Division of Dockets validity of the methodology and
Management (HFA–305), Food and Drug assumptions used; (3) ways to enhance
Administration, 5630 Fishers Lane, rm. the quality, utility, and clarity of the
DEPARTMENT OF HEALTH AND 1061, Rockville, MD 20852. All information to be collected; and (4)
HUMAN SERVICES comments should be identified with the ways to minimize the burden of the
docket number found in brackets in the collection of information on
Food and Drug Administration heading of this document. respondents, including through the use
FOR FURTHER INFORMATION CONTACT: of automated collection techniques,
[Docket No. 2006N–0326]
Denver Presley, Jr., Office of when appropriate, and other forms of
Agency Information Collection Management Programs (HFA–250), Food information technology.
Activities; Proposed Collection; and Drug Administration, 5600 Fishers
Medical Devices: Inspection by
Comment Request; Inspection by Lane, Rockville, MD 20857, 301–827–
Accredited Persons Program Under
Accredited Persons Program Under 1472.
MDUFMA (OMB Control Number 0910–
the Medical Device User Fee and SUPPLEMENTARY INFORMATION: Under the 0510)—Extension
Modernization Act of 2002 PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the The Medical Device User Fee and
AGENCY: Food and Drug Administration, Office of Management and Budget Modernization Act of 2002 (MDUFMA)
HHS. (OMB) for each collection of (Public Law 107–250) was signed into
ACTION: Notice. information they conduct or sponsor. law on October 26, 2002. Section 201 of
‘‘Collection of information’’ is defined MDUFMA adds a new paragraph ‘‘g’’ to
SUMMARY: The Food and Drug
in 44 U.S.C. 3502(3) and 5 CFR section 704 of the Federal, Food, Drug,
Administration (FDA) is announcing an 1320.3(c) and includes agency requests and Cosmetic Act (the act) (21 U.S.C.
opportunity for public comment on the or requirements that members of the 374), directing FDA to accredit third
proposed collection of certain public submit reports, keep records, or parties (accredited persons or APs) to
information by the agency. Under the provide information to a third party. conduct inspections of eligible
Paperwork Reduction Act of 1995 (the Section 3506(c)(2)(A) of the PRA (44 manufacturers of class II or class III
PRA), Federal agencies are required to U.S.C. 3506(c)(2)(A)) requires Federal devices. This is a voluntary program.
publish notice in the Federal Register agencies to provide a 60-day notice in
concerning each proposed collection of FDA has a guidance document that
the Federal Register concerning each provides information for those
information, including each proposed proposed collection of information,
extension of an existing collection of interested in participating in this
including each proposed extension of an program. The guidance is entitled
information, and to allow 60 days for existing collection of information,
public comment in response to the ‘‘Implementation of the Inspection by
before submitting the collection to OMB Accredited Persons Program Under the
notice. This notice solicits comments on for approval. To comply with this
the publication of the criteria FDA Medical Device User Fee and
requirement, FDA is publishing notice Modernization Act of 2002;
intends to use to accredit third parties of the proposed collection of
to conduct inspections of eligible Accreditation Criteria.’’
information set forth in this document.
manufacturers of class II or class III With respect to the following Description of Respondents:
medical devices. collection of information, FDA invites Businesses or other for profit
DATES: Submit written or electronic comments on these topics: (1) Whether organizations.
comments on the collection of the proposed collection of information FDA estimates the burden of this
information by October 23, 2006. is necessary for the proper performance collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1


No. of Annual Frequency Total Annual Hours per
Information Collection: Total Hours
Respondents per Response Responses Response

Request for Accreditation 3 1 3 80 240

Total Hours 240


1There are no capital costs or operating and maintenance costs associated with this collection of information.
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50068 Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Notices

FDA based these estimates on method enhancement activities to radiological screening and analysis
conversations with industry, trade extend analysis capability, and analysis methodologies that are used to evaluate
association representatives, and internal of surveillance samples. In the event of foods and food products in such
FDA estimates. Once an organization is a large-scale radiological terrorism event situations. However, in the event of a
accredited, it will not be required to affecting foods or food products, the large-scale emergent incident, analytical
reapply. recipient may be required to perform sample capacity in ORA field
Dated: August 18, 2006. selected radiological analyses of laboratories has a finite limit.
domestic and imported food samples Information from ongoing relationships
Jeffrey Shuren,
collected and supplied to the laboratory with state partners indicates limited
Assistant Commissioner for Policy.
by FDA or other Federal agencies redundancy in state food testing
[FR Doc. E6–14056 Filed 8–23–06; 8:45 am] through FDA. These samples may laboratories, both in terms of analytical
BILLING CODE 4160–01–S consist of, but are not limited to, the capabilities and analytical sample
following: vegetables and fruits (fresh capacity. Several state food testing
and packaged); juices (concentrate and laboratories lack the specialized
DEPARTMENT OF HEALTH AND diluted); grains and grain products; equipment to perform the analyses and/
HUMAN SERVICES seafood and other fish products; milk or the specific methodological expertise
and other dairy products; infant in the types of analyses performed for
Food and Drug Administration
formula; baby foods; bottled water; screening foods and food products
Food Safety and Security Monitoring condiments; and alcoholic beverage involving radiological terrorism events.
Project—Radiological Health; products. Subtitle A of Title III of the
Announcement Type: Cooperative All grant application projects that are Bioterrorism Act, Protection of Food
Agreements Under a Limited developed at State, local, and tribal Supply, section 312-Surveillance and
Competition; Funding Opportunity governmental levels must have national Information Grants and Authorities,
Number: Request for Applications: application that can enhance Federal amends part B of Title III of the Public
RFA–FDA–ORA–2006–4; Catalog of food safety and security programs. At Health Service Act to authorize the
Federal Domestic Assistance Number: the discretion of the FDA, successful Secretary of Health and Human Services
93.448 project formats will be made available to (the Secretary) to award grants to States
interested Federal, State, local and tribal and Indian tribes to expand
AGENCY: Food and Drug Administration, government FERN laboratories. participation in networks to enhance
HHS. There are two key project areas
Federal, State, and local food safety
ACTION: Notice. identified for this effort:
(1) The use of Gamma Spectrometry efforts. This may include meeting the
analysis for the screening and costs of establishing and maintaining
I. Funding Opportunity Description the food safety surveillance, technical,
identification of gamma emitting
The Food and Drug Administration radionuclides in foods; and and laboratory capacity needed for such
(FDA), Office of Regulatory Affairs (2) The use of Beta Spectrometry participation.
(ORA), Division of Federal-State analysis for the screening and 2. Program Research Goals
Relations (DFSR), is announcing the identification of beta emitting
availability of cooperative agreements radionuclides in foods. The goal of ORA’s cooperative
for equipment, supplies, personnel, FDA will support the projects covered agreement program is to complement
training, and facility upgrades to Food by this notice under the authority of and improve State, local and Indian
Emergency Response Laboratory section 312 of the Public Health tribal food safety and security testing
Network (FERN) radiological Security and Bioterrorism Preparedness programs. This will be accomplished
laboratories of State, local, and tribal and Response Act of 2002 (the through the provision of equipment,
governments. The cooperative Bioterrorism Act) (Public Law 107–188). supplies, personnel, facility upgrades,
agreements are to enable the analyses of This program is described in the Catalog training in current food testing
foods and food products in the event of Federal Domestic Assistance under methodologies, participation in
that redundancy and/or additional 93.448. proficiency testing to establish
laboratory surge capacity is needed by additional reliable laboratory sample
FERN for analyses related to 1. Background analysis capacity, analysis of
radiological terrorism or other ORA is the primary inspection and surveillance samples, and in
emergency situation. These cooperative analysis component of FDA/ORA has cooperation with FDA, participation in
agreements are also intended to expand approximately 1,600 investigators, method enhancement activities
participation in networks to enhance inspectors, and analysts who cover the designed to extend analytical
Federal, State, local, and tribal country’s approximately 95,000 FDA capabilities. In the event of a large-scale
governmental food safety and security regulated businesses. These radiological terrorism event affecting
efforts. investigators inspect more that 15,000 foods or food products, the recipient
The goal of ORA’s cooperative facilities a year; and ORA laboratories may be required to perform selected
agreement program is to complement analyze several thousand samples per radiological analyses of domestic and
and improve State, local and Indian year. ORA conducts special imported food samples collected and
tribal governmental food safety and investigations, food inspection recall supplied to the laboratory by FDA or
security testing programs. This will be audits, performs consumer complaint other Federal agencies through FDA.
accomplished through the provision of inspections, and collects samples of These samples may consist of, but are
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supplies, personnel, facility upgrades, regulated products. Increasingly, ORA not limited to, the following: vegetables
training in current food testing has been called upon to expand the and fruits (fresh and packaged); juices
methodologies, participation in testing program to address the (concentrate and diluted); grains and
proficiency testing to establish increasing threat to food safety and grain products; seafood and other fish
additional reliable laboratory sample security through intentional radiological products; milk and other dairy products;
analysis capacity, participation in terrorism events. ORA developed infant formula; baby foods; bottled

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