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Federal Register / Vol. 72, No.

129 / Friday, July 6, 2007 / Notices 37025

Marketing (NCHM), Centers for Disease events, which may have multi- assist with the decision-making process.
Control and Prevention (CDC). jurisdictional involvement and cause Presently, the necessity of this
disease and death within a short time- evaluation process is timely because of
Background and Brief Description
frame. ongoing terrorism threats and acts
A central component of the CDC’s The purpose of the information perpetrated worldwide.
mission is to strengthen the nation’s gathered during this notification The survey information will be
public health infrastructure by proficiency testing exercise is to gathered through an online
coordinating public health surveillance evaluate the extent to which new questionnaire format, and help evaluate
at CDC and providing domestic and registrants and currently authorized user comprehension and facility solely
international support through scientific users of the Epidemic Information with the targeted notification and rapid
communications and terrorism Exchange (Epi-X) are able to utilize alert alerting functionalities of Epi-X. The
preparedness and emergency response. notification functionality to minimize or questionnaire will consist of both
The Epidemic Information Exchange prevent unnecessary injury or disease- closed- and open-ended items, and will
(Epi-X) provides CDC and its state and related morbidity and mortality through be administered through Zoomerang, an
local partners and collaborators with a the use of secure communications and online questionnaire program, or as a
secure public health communications rapid notification systems. In this case, last resort, by telephone. Approximately
network intended for routine and notification alerts would be sent to 1,000 Epi-X users from every state of the
emergent information exchange in a targeted public health professionals union will be asked to volunteer input
secure environment. through a ‘‘barrage’’ of office cell phone, (in a 5–10 question format) about their
Great attention has been focused on home telephone, and pager calls to experiences using the alert notification
improving secure public health rapidly inform key health authorities functionalities of the Epi-X
communications networks for the from multidisciplinary backgrounds and communications system. There will be
dissemination of critical disease multiple jurisdictions of evolving and no cost to respondents, whose
outbreak and/or bioterrorism-related critical public health information, and participation will be strictly voluntary.

ESTIMATED ANNUALIZED BURDEN HOURS


Average
Number of
Number of burden per Total burden
Respondents responses per
respondents response (in hours)
respondent (in hours)

Public Health Professionals ............................................................................. 1,000 1 10/60 167

Dated: June 29, 2007. DATES: Applications are due within 30 improving food safety and nutrition as
Maryam I. Daneshvar, days after the publication of the funding well as other program areas that impact
Acting Reports Clearance Officer, Centers for opportunity in the Federal Register. on public health policy.
Disease Control and Prevention. FOR FURTHER INFORMATION CONTACT: II. Eligibility Information
[FR Doc. E7–13086 Filed 7–5–07; 8:45 am] Gladys M. Bohler, Office of Acquisition
BILLING CODE 4163–18–P and Grants Services, Food and Drug FDA believes UMCP is uniquely
Administration, 5630 Fishers Lane, rm. qualified to fulfill the objectives of the
2105, Rockville, MD 20857, 301–827– proposed cooperative agreement. UMCP
DEPARTMENT OF HEALTH AND 7168, or e-mail: gladys.melendez- is in close proximity to the FDA’s
HUMAN SERVICES bohler@fda.hhs.gov. Center for Food Safety and Applied
Nutrition (CFSAN) and the Center for
Food and Drug Administration SUPPLEMENTARY INFORMATION:
Veterinary Medicine offices and
I. Funding Opportunity Description laboratories in Prince Georges County,
Cooperative Agreement to Support the MD. UMCP has vast resources which
Joint Institute for Food Safety and Funding Opportunity Number; Notice of complement and greatly expand FDA’s
Applied Nutrition Intent to Renew a Cooperative research, scientific, education and
Agreement; RFA–FD–07–001 CFSAN outreach resources. As the UMCP and
AGENCY: Food and Drug Administration,
Catalog of Federal Domestic Assistance FDA are both located within the greater
HHS.
Number: 93.103 Washington, DC area increased
ACTION: Notice.
An estimated amount of support in interactions with the USDA Beltsville
SUMMARY: The Food and Drug FY07 will be for up to $2.0 million Agricultural Research Center and other
Administration (FDA) is announcing its (direct plus indirect cost) the total world class research and medical
intention to receive and consider a amount being subject to annual budget institutions are possible. UMCP is the
single source application for the award appropriations, with an additional 4 Washington region’s most
of a cooperative agreement in fiscal year years of support. JIFSAN is located on comprehensive research institution,
2007 (FY) to the University of Maryland, the University of Maryland Campus in with numerous academic programs
College Park (UMCP) to support the College Park, MD. Competition is relevant to FDA’s mission and the
Joint Institute for Food Safety and limited to UMCP because of the unique resources to support CFSAN’s areas of
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Applied Nutrition (JIFSAN). This award partnership between FDA and UMCP. interest, including: microbiology,
will strengthen existing programs and The cooperative agreement will chemistry, food science, animal health
allow expansion of JIFSAN’s education, continue to allow for a more efficient sciences, agriculture, public policy, risk
outreach and applied research programs use of research, scientific, education, assessment, computational science,
and external partnerships that have and outreach resources which enhance economics, and survey methodology.
already been established. overall public health by expanding and UMCP serves as a primary center for

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37026 Federal Register / Vol. 72, No. 129 / Friday, July 6, 2007 / Notices

graduate study and research and Risk Analysis. These agreements enable apply for a grant or cooperative
provides undergraduate and graduate UMCP and JIFSAN to: (1) Further agreement from the Federal government.
instruction across a broad spectrum of promote international scientific, The DUNS number is a 9–digit
academic disciplines. The University education, outreach and cooperative identification number, which uniquely
extends its intellectual resources to the research activities; and (2) deepen the identifies business entities. Obtaining a
community through innovative projects understanding of the scientific, DUNS number is easy and there is no
designed to serve individuals, economic and social issues/needs charge. To obtain a DUNS number, call
governments and the private sector within the respective countries. 1–866–705–5711. Be certain that you
throughout the State of Maryland, the Acknowledging the importance of an identify yourself as a Federal grant
nation, and the international interdisciplinary approach to applicant when you contact Dun and
community. knowledge, the University maintains Bradstreet.
The University has developed core organized research units outside the
facilities to provide effective use of usual academic department structures. III. Application and Submission
state-of-the-art scientific Through collaborative projects, FDA has FDA will accept the application for
instrumentation with high acquisition, access to additional University this program electronically via http://
installation, and maintenance costs to resources that include: (1) The Center www.grants.gov. The applicant is
conduct research at the forefront of for Risk Communication Research encouraged to apply electronically by
science. An electron microscopy facility where cooperative projects related to visiting the Web site http://
jointly supported by FDA and the risk communication studies have been www.grants.gov and following
University opened in 2000. CFSAN has and will continue to be developed; (2) instructions under ‘‘Apply for Grants.’’
moved its nuclear magnetic resonance The Center for Food Systems Security The required application, SF 424
(NMR) instrumentation and personnel and Safety, within the College of (Research & Related) (also referred to as
to the University’s NMR facility in the Agriculture and Natural Resources, the ‘‘SF424 (R&R)’’), can be completed
Chemistry building. These providing opportunities for the and submitted online. The package
instrumentation centers complement development of multidisciplinary food should be labeled ‘‘Response to RFA-
CFSAN’s resources and expertise.The safety research using an integrated food FD-07 001’’. If you experience technical
University has developed http:// systems approach; and (3) The difficulties with your online submission
www.FoodRisk.org (formerly the Risk Maryland NanoCenter established as a you should contact Gladys M. Bohler by
Analysis Clearinghouse) which is the partnership among the A. James Clark telephone 301–827–7168 or by e-mail:
only web-based information resource School of Engineering, the College of gladys.melendez-bohler@fda.hhs.gov.
specializing in food safety risk analysis, Computer, Math, and Physical Sciences Information about submitting an
including risk assessment, risk (CMPS), and the College of Chemical application electronically can be found
management, and risk communication. and Life Sciences provides access to on the http://www.grants.gov Web site.
Users include government officials from major nano-research, equipment and In order to apply electronically, the
around the world seeking the latest risk informational seminars that could foster applicant must have a DUNS number
assessment, or training and workshop trans-disciplinary collaboration among a and register in the central contractor
opportunities. The Web site for critical mass of researchers spanning the registration (CCR) database.
FoodRisk.org contains: (1) Data and sciences and engineering.
As UMCP is part of the University A. Dun and Bradstreet Number (DUNS)
tools for researchers seeking to fill data
gaps, build models, and develop System of Maryland (comprised of As of October 1, 2003, applicants are
expertise; (2) specialized data, peer eleven universities, two research required to have a DUNS number to
networks, and access to modeling tools institutions and two regional higher apply for a grant or cooperative
for risk assessors and project managers; education centers) additional education, agreement from the Federal government.
and (3) the latest risk assessments, and research and outreach expertise through The DUNS number is a 9-digit
information on workshops and training affiliated campuses/faculty may be identification number, which uniquely
opportunities for interested individuals accessed to build additional identifies business entities. Obtaining a
from around the world. The Web site for relationships that advance our mutual DUNS number is easy and there is no
FoodRisk.org also operates the Food and goals. Collaboration between the public charge. To obtain a DUNS number, call
Agricultural Organization/World Health and the private sectors has proven to be 1–866–705–5711. Be certain that you
Organization (FAO/WHO) Acrylamide an efficient means for both FDA and the identify yourself as a Federal grant
in Food Network, the internationally University to remain current with applicant when you contact Dun and
sanctioned repository for information scientific and technical advances Bradstreet.
about the safety and prevention of associated with FDA regulated products
B. Central Contractor Registration
acrylamide in food. (i.e., foods, cosmetics and animal drugs
The University through JIFSAN has and feed additives). The degree to Applicants must register with the CCR
developed a broad range of international which we nurture, develop and build on database. This database is a government-
agreements with: (1) The Ministry of these collaborations directly impacts wide warehouse of commercial and
Science and Technology Thailand; (2) our ability to enhance public health. financial information for all
the Korea Food and Drug The information and expertise obtained organizations conducting business with
Administration (KFDA); (3) the Central through this partnership between FDA the Federal Government. The preferred
Science Laboratory, Department for and UMCP can be leveraged by all method for completing a registration is
Environment Food and Rural Affairs in segments of the food safety and through the World Wide Web at http://
York, UK; and (4) the Department of nutrition community, as well as by www.ccr.gov. This Web site provides a
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Natural Resources and Environment in public health organizations, other CCR handbook with detailed
Victoria Australia. Additionally JIFSAN Federal agencies, and academic information on data you will need prior
has been designated a Pan American institutions in the performance of their to beginning the online pre-registration,
Health Organization/World Health roles. as well as steps to walk you through the
Organization (PAHO/WHO) As of October 1, 2003, applicants are registration process. You must have a
Collaborating Center for Food Safety required to have a DUNS number to DUNS number to begin your

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Federal Register / Vol. 72, No. 129 / Friday, July 6, 2007 / Notices 37027

registration. For foreign entities the Web mammography remains available to authorized by Congress. FDA needs to
site is http://www.grants.gov/ women. This document explains which be able to collect the full cost of
RequestaDUNS.gov.In order to access facilities are subject to payment of mammography inspections to ensure it
grants.gov an applicant will be required inspection fees, provides information on has the resources to ensure high quality
to register with the Credential Provider. the costs included in developing mammography remains available to
Information about this is available at inspection fees, and provides women. Accordingly, the fees have been
https://apply.grants.gov/OrcRegister. information on the inspection billing recalculated so that the aggregate
A copy of the complete RFA can also and collection processes. amount of fees collected will equal the
be viewed on FDA’s Center for Food DATES: Effective October 1, 2007, for all aggregate recoverable costs of the
Safety and Applied Nutrition Web site inspections conducted under section inspections conducted, as mandated by
at http://www.cfsan.fda.gov/list.html. 354(g) of the Public Health Service Act the MQSA. Therefore, FDA is providing
(FDA has verified the Web site and its (PHS Act) (42 U.S.C. 263b(g)). Submit notice of the increased fees to be
address but we are not responsible for written or electronic comments by assessed starting on October 1, 2007,
changes subsequent to the Web site or October 1, 2007. and additional information relating to
its address after this document ADDRESSES: Submit written comments
those fees.
publishes in the Federal Register).
to the Division of Dockets Management II. Inspections Under the
IV. Agency Contacts (HFA–305), Food and Drug Mammography Quality Standards Act
For issues regarding the programmatic Administration, 5630 Fishers Lane, rm. of 1992
aspects of this document, contact 1061, Rockville, MD 20852. Submit Section 354(g)(1) of the PHS Act
Christine L. Hileman, Center for Food electronic comments to http:// requires FDA, States as Certifier (SAC)
Safety and Applied Nutrition (HFS-006), www.fda.gov/dockets/ecomments. States, or a State or local agency acting
Food and Drug Administration, 5100 Identify comments with the docket on behalf of the FDA, to conduct an
Paint Branch Pkwy., College Park, MD number found in brackets in the annual inspection of each
20740, 301–436–1674, or e-mail: heading of this document. mammography facility. The purpose of
christine.hileman@fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: the annual inspection is to determine
For issues regarding the Helen J. Barr, Center for Devices and facility compliance with quality
administrative and financial Radiological Health (HFZ–240), Food standards established under the MQSA.
management aspects of this document and Drug Administration, 1350 Piccard Inspectors who have met Federal
contact, Gladys Melendez-Bohler at Dr., Rockville, MD 20850, 240–276– training requirements and who are
301–827–7168 or by e-mail: 3332, FAX: 240–276–3272. qualified by FDA will conduct
gladys.melendez-bohler@fda.hhs.gov. SUPPLEMENTARY INFORMATION: inspections.
Dated: June 26, 2007. Under ordinary circumstances,
I. Background
Jeffrey Shuren,
inspections will be conducted during
The MQSA requires all the regular business hours of the facility
Assistant Commissioner for Policy. mammography facilities, other than or at a mutually agreed time. FDA
[FR Doc. E7–13046 Filed 7–5–07; 8:45 am] facilities of the Department of Veterans normally will provide 5 working days
BILLING CODE 4160–01–S Affairs, to be accredited by an approved advance notice of each annual
accreditation body and certified by the inspection. If a significant deficiency is
Secretary of Health and Human identified during an inspection, FDA
DEPARTMENT OF HEALTH AND Services, as meeting quality standards will provide information on necessary
HUMAN SERVICES (section 354(b) and (d) of the PHS Act). corrective action and, in appropriate
Food and Drug Administration The MQSA requires FDA to establish cases, will schedule a followup
and operate the following: (1) A Federal inspection after the facility has had a
[Docket No. 2007N–0238] certification and inspection program for reasonable time to correct the
mammography facilities, (2) regulations deficiency. FDA normally will provide
Medical Devices: The Mammography and standards for accreditation bodies, 5 working days advance notice of each
Quality Standards Act of 1992 and and (3) standards for equipment, followup inspection. FDA may make
Subsequent Mammography Quality personnel, quality assurance, and unannounced inspections or may
Standards Reauthorization Act and recordkeeping and reporting by provide shorter notice if prompt action
Amendments; Inspection Fees mammography facilities (section 354(c), is necessary to protect the public health
AGENCY: Food and Drug Administration, (e), (f), and (g) of the PHS Act). The (see section 354(g)(4) of the PHS Act).
HHS. MQSA requires annual facility
inspections to determine compliance III. Costs Included in the Fees to Be
ACTION: Notice. Assessed Beginning on October 1, 2007
with the quality standards (section
SUMMARY: The Food and Drug 354(g) of the PHS Act). Section 354(r) of Section 354(r) of the PHS Act requires
Administration (FDA) is announcing the the PHS Act requires FDA to assess and FDA to assess and collect fees from
increased fees the agency will assess for collect fees for inspections of persons who own or lease
inspections of mammography facilities mammography facilities, other than mammography facilities, or their agents,
starting October 1, 2007. The governmental entities as determined by to cover the costs of inspections
Mammography Quality Standards Act of FDA, to cover the costs of inspections. conducted by FDA, SAC States, or a
1992 (the MQSA) requires FDA to assess An updated resource review has State or local agency acting on behalf of
and collect fees from mammography demonstrated that the recoverable costs FDA. Section 354(r) of the PHS Act
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facilities to cover the costs of annual of the MQSA inspection program have limits FDA’s discretion in setting
inspections required by the MQSA. increased since the last notice on fees in inspection fees in three ways: (1) Fees
Because these costs have increased, 2003 (68 FR 5289, September 4, 2003). must be set so that, for a given fiscal
FDA is raising the fees to ensure the In addition, the annual amount of fees year (FY), the aggregate amount of fees
program is able to meet its objective of collected under the current fee schedule collected will equal the aggregate costs
ensuring that high quality has been well below the level of inspections conducted; (2) a facility’s

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