80 FR 46027 - Joint Food and Drug Administration/Health Canada Quantitative Assessment of the Risk of Listeriosis From Soft-Ripened Cheese Consumption in the United States and Canada
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 148 (August 3, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 148 (August 3, 2015)
| Page Range | 46027-46028 | |
| FR Document | 2015-18960 |
[Federal Register Volume 80, Number 148 (Monday, August 3, 2015)] [Notices] [Pages 46027-46028] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-18960] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1182] Joint Food and Drug Administration/Health Canada Quantitative Assessment of the Risk of Listeriosis From Soft-Ripened Cheese Consumption in the United States and Canada AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of the ``Joint Food and Drug Administration/Health Canada--Sant[eacute] Canada Quantitative Assessment of the Risk of Listeriosis From Soft-Ripened Cheese Consumption in the United States and Canada.'' We are making available an interpretative summary, a technical Quantitative Risk Assessment (QRA) report with appendices, a risk-assessment model, and a document responding to public comments that we received regarding the 2013 ``Draft Joint Food and Drug Administration/Health Canada--Sant[eacute] Canada Quantitative Assessment of the Risk of Listeriosis From Soft-Ripened Cheese Consumption in the United States and Canada.'' The purpose of the QRA is to evaluate the effect of factors such as the microbiological status of milk, cheese-manufacturing steps, and conditions during distribution and storage on the overall risk of invasive listeriosis to the consumer of soft-ripened cheese in the United States or Canada. The QRA [[Page 46028]] makes it possible to evaluate the effectiveness of some process changes and intervention strategies in reducing the risk of listeriosis. ADDRESSES: See the SUPPLEMENTARY INFORMATION section for electronic access to the QRA and related documents. FOR FURTHER INFORMATION CONTACT: Sherri Dennis, Center for Food Safety and Applied Nutrition (HFS-005), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1914. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of February 11, 2013 (78 FR 9701), we made available a document entitled ``Draft Joint Food and Drug Administration/Health Canada--Sant[eacute] Canada Quantitative Assessment of the Risk of Listeriosis From Soft-Ripened Cheese Consumption in the United States and Canada.'' We gave interested parties an opportunity to submit comments by April 29, 2013, for us to consider on the approach used, the assumptions made, the modeling techniques, the data used, and the clarity and the transparency of the QRA documentation. We received nearly 100 comments on the draft QRA and have revised the QRA where appropriate (See Refs. 1 to 5). Elsewhere in this issue of the Federal Register, we are issuing a notice requesting comments and scientific data and information that would assist us in understanding potential intervention measures to reduce the risk of foodborne illness from consumption of cheeses manufactured from unpasteurized milk. II. Electronic Access The QRA and related documents are available electronically on the FDA Web site at http://www.fda.gov/Food/FoodScienceResearch/RiskSafetyAssessment/default.htm, http://www.fda.gov/ScienceResearch/SpecialTopics/PeerReviewofScientificInformationandAssessments/ucm079120.htm, and http://www.regulations.gov. III. References The following references have been placed on display in the Division of Dockets Management (see ADDRESSES) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and are available electronically at http://www.regulations.gov. (FDA has verified the Web site addresses in this reference section, but we are not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) 1. FDA and Health Canada, ``Joint Food and Drug Administration/ Health Canada--Sant[eacute] Canada Quantitative Assessment of the Risk of Listeriosis from Soft-Ripened Cheese Consumption in the United States and Canada: Interpretative Summary,'' 2015. Accessible at http://www.fda.gov/Food/FoodScienceResearch/RiskSafetyAssessment/default.htm and http://www.fda.gov/ScienceResearch/SpecialTopics/PeerReviewofScientificInformationandAssessments/ucm079120.htm. 2. FDA and Health Canada, ``Joint Food and Drug Administration/ Health Canada--Sant[eacute] Canada Quantitative Assessment of the Risk of Listeriosis from Soft-Ripened Cheese Consumption in the United States and Canada: Technical Report,'' 2015. Accessible at http://www.fda.gov/Food/FoodScienceResearch/RiskSafetyAssessment/default.htm and http://www.fda.gov/ScienceResearch/SpecialTopics/PeerReviewofScientificInformationandAssessments/ucm079120.htm. 3. FDA and Health Canada, ``Joint Food and Drug Administration/ Health Canada--Sant[eacute] Canada Quantitative Assessment of the Risk of Listeriosis from Soft-Ripened Cheese Consumption in the United States and Canada: Technical Report Appendices,'' 2015. Accessible at http://www.fda.gov/Food/FoodScienceResearch/RiskSafetyAssessment/default.htm and http://www.fda.gov/ScienceResearch/SpecialTopics/PeerReviewofScientificInformationandAssessments/ucm079120.htm. 4. FDA and Health Canada, ``Joint Food and Drug Administration/ Health Canada--Sant[eacute] Canada Quantitative Assessment of the Risk of Listeriosis from Soft-Ripened Cheese Consumption in the United States and Canada: Risk Assessment Model,'' 2015. Accessible at http://www.fda.gov/Food/FoodScienceResearch/RiskSafetyAssessment/default.htm and http://www.fda.gov/ScienceResearch/SpecialTopics/PeerReviewofScientificInformationandAssessments/ucm079120.htm. 5. Joint FDA/Health Canada Quantitative Assessment of the Risk of Listeriosis from Soft-Ripened Cheese Consumption in the United States and Canada: Replies to Public Comments, 2015. Accessible at http://www.fda.gov/Food/FoodScienceResearch/RiskSafetyAssessment/default.htm and http://www.fda.gov/ScienceResearch/SpecialTopics/PeerReviewofScientificInformationandAssessments/ucm079120.htm. Dated: July 29, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-18960 Filed 7-31-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices 46027
Topic 1: Disease Symptoms and Daily would you look for in an ideal treatment pertaining to topics 1 and 2 to the
Impacts That Matter Most to Patients for your condition? Division of Dockets Management (see
In the afternoon, discussion will be ADDRESSES) by December 15, 2015. It is
1. Of all the symptoms that you
related to scientific topics, with the goal only necessary to send one set of
experience because of your condition,
of understanding issues that may affect comments. Identify comments with the
which 1–3 symptoms have the most
the development of drugs for the docket number found in brackets in the
significant impact on your life?
treatment of NTM lung infections and heading of this document. Received
(Examples may include cough,
identifying topics for future discussion. comments may be seen in the Division
increased sputum production, shortness
Discussion topics for the afternoon will of Dockets Management between 9 a.m.
of breath, difficulty breathing, chest include the following: Epidemiology and 4 p.m., Monday through Friday, and
pain) and natural history of NTM lung will be posted to the docket at http://
2. Are there specific activities that are
infections, current treatment www.regulations.gov.
important to you but that you cannot do
considerations, clinical trial designs,
at all or as fully as you would like V. Transcripts
and clinical trial endpoints.
because of your condition? (Examples of As soon as a transcript is available,
activities may include sleeping through III. Attendance and Registration FDA will post it at http://www.fda.gov/
the night, daily hygiene, driving, If you wish to attend this meeting, Drugs/NewsEvents/ucm453877.htm.
walking/running, exercising, etc.) visit http://ntmpfdd.eventbrite.com. Dated: July 28, 2015.
• How do your symptoms and their Please register by October 7, 2015. If you
negative impacts affect your daily life Leslie Kux,
are unable to attend the meeting in
on the best days? On the worst days? Associate Commissioner for Policy.
person, you can register to view a live
(Examples may include limitations on [FR Doc. 2015–18919 Filed 7–31–15; 8:45 am]
Webcast of the meeting. You will be
the ability to undertake physically asked to indicate in your registration if BILLING CODE 4164–01–P
strenuous activities, restrictions on the you plan to attend in person or via the
ability to travel, inability to sleep, lack Webcast. Seating will be limited, so
of appetite, fatigue, etc.) DEPARTMENT OF HEALTH AND
early registration is recommended.
3. How has your condition and its HUMAN SERVICES
Registration is free and will be on a first-
symptoms changed over time? come, first-served basis. However, FDA Food and Drug Administration
• Do your symptoms come and go? If may limit the number of participants
so, do you know of anything that makes from each organization based on space [Docket No. FDA–2012–N–1182]
your symptoms better? Worse? limitations. Registrants will receive
4. What worries you most about your Joint Food and Drug Administration/
confirmation once they have been Health Canada Quantitative
condition? accepted. Onsite registration on the day Assessment of the Risk of Listeriosis
Topic 2: Patients’ Perspectives on of the meeting will be based on space From Soft-Ripened Cheese
Current Approaches To Treating NTM availability. Consumption in the United States and
Lung Infections If you need special accommodations
Canada
because of a disability, please contact
1. What are you currently doing to Graham Thompson at least 7 days before AGENCY: Food and Drug Administration,
help treat your condition or its the meeting. HHS.
symptoms? (Examples may include ACTION: Notice.
prescription medicines, over-the- IV. Comments
counter products, nebulizers, and other Patients who are interested in SUMMARY: The Food and Drug
therapies including non-drug therapies) presenting comments as part of the Administration (FDA or we) is
• What specific symptoms do your initial panel discussions will be asked announcing the availability of the ‘‘Joint
treatments address? to indicate in their registration which Food and Drug Administration/Health
• How has your treatment regimen topic(s) they wish to address. These Canada—Santé Canada Quantitative
changed over time, and why? patients also must send to Assessment of the Risk of Listeriosis
2. How well does your current PatientFocused@fda.hhs.gov a brief From Soft-Ripened Cheese
treatment regimen treat the most summary of responses to the topic Consumption in the United States and
significant symptoms of your disease? questions by September 28, 2015. Canada.’’ We are making available an
• How well do these treatments stop Panelists will be notified of their interpretative summary, a technical
or slow the progression of your disease? selection approximately 7 days before Quantitative Risk Assessment (QRA)
• How well do these therapies the public meeting. We will try to report with appendices, a risk-
improve your ability to do specific accommodate all patients and patient assessment model, and a document
activities that are important to you in stakeholders who wish to speak, either responding to public comments that we
your daily life? through the panel discussion or received regarding the 2013 ‘‘Draft Joint
• How well have these treatments audience participation; however, the Food and Drug Administration/Health
worked for you as your condition has duration of comments may be limited by Canada—Santé Canada Quantitative
changed over time? time constraints. Assessment of the Risk of Listeriosis
3. What are the most significant FDA will hold an open public From Soft-Ripened Cheese
downsides to your current treatments, comment period to give the public an Consumption in the United States and
mstockstill on DSK4VPTVN1PROD with NOTICES
and how do they affect your daily life? opportunity to comment. Registration Canada.’’ The purpose of the QRA is to
(Examples of downsides may include for open public comment will occur at evaluate the effect of factors such as the
bothersome side effects, need for the registration desk on the day of the microbiological status of milk, cheese-
multiple medications, need for meeting and workshop on a first-come, manufacturing steps, and conditions
injections, going to the hospital for first-served basis. during distribution and storage on the
treatment, etc.) Regardless of attendance at the public overall risk of invasive listeriosis to the
4. Assuming there is no complete cure meeting, you can submit electronic or consumer of soft-ripened cheese in the
for your condition, what specific things written responses to the questions United States or Canada. The QRA
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![46028 Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices
makes it possible to evaluate the after this document publishes in the DEPARTMENT OF HEALTH AND
effectiveness of some process changes Federal Register.) HUMAN SERVICES
and intervention strategies in reducing 1. FDA and Health Canada, ‘‘Joint Food and
the risk of listeriosis. Drug Administration/Health Canada— Food and Drug Administration
ADDRESSES: See the SUPPLEMENTARY Santé Canada Quantitative Assessment [Docket No. FDA–2015–N–0007]
INFORMATION section for electronic of the Risk of Listeriosis from Soft-
access to the QRA and related Ripened Cheese Consumption in the Prescription Drug User Fee Rates for
documents. United States and Canada: Interpretative Fiscal Year 2016
Summary,’’ 2015. Accessible at http://
FOR FURTHER INFORMATION CONTACT: www.fda.gov/Food/FoodScience AGENCY: Food and Drug Administration,
Sherri Dennis, Center for Food Safety Research/RiskSafetyAssessment/ HHS.
and Applied Nutrition (HFS–005), Food default.htm and http://www.fda.gov/ ACTION: Notice.
and Drug Administration, 5100 Paint ScienceResearch/SpecialTopics/Peer
Branch Pkwy., College Park, MD 20740, ReviewofScientificInformationand SUMMARY: The Food and Drug
240–402–1914. Assessments/ucm079120.htm. Administration (FDA) is announcing the
SUPPLEMENTARY INFORMATION: 2. FDA and Health Canada, ‘‘Joint Food and rates for prescription drug user fees for
Drug Administration/Health Canada— fiscal year (FY) 2016. The Federal Food,
I. Background Santé Canada Quantitative Assessment Drug, and Cosmetic Act (the FD&C Act),
In the Federal Register of February of the Risk of Listeriosis from Soft- as amended by the Prescription Drug
11, 2013 (78 FR 9701), we made Ripened Cheese Consumption in the User Fee Amendments of 2012 (PDUFA
United States and Canada: Technical V), authorizes FDA to collect user fees
available a document entitled ‘‘Draft
Report,’’ 2015. Accessible at http:// for certain applications for the review of
Joint Food and Drug Administration/ www.fda.gov/Food/FoodScience
Health Canada—Santé Canada human drug and biological products, on
Research/RiskSafetyAssessment/ establishments where the products are
Quantitative Assessment of the Risk of default.htm and http://www.fda.gov/
Listeriosis From Soft-Ripened Cheese made, and on such products. This
ScienceResearch/SpecialTopics/Peer
Consumption in the United States and ReviewofScientificInformationand
notice establishes the fee rates for FY
Canada.’’ We gave interested parties an Assessments/ucm079120.htm. 2016.
opportunity to submit comments by 3. FDA and Health Canada, ‘‘Joint Food and FOR FURTHER INFORMATION CONTACT:
April 29, 2013, for us to consider on the Drug Administration/Health Canada— Robert J. Marcarelli, Office of Financial
approach used, the assumptions made, Santé Canada Quantitative Assessment Management, Food and Drug
the modeling techniques, the data used, of the Risk of Listeriosis from Soft- Administration, 8455 Colesville Rd.,
and the clarity and the transparency of Ripened Cheese Consumption in the COLE–14202F, Silver Spring, MD
United States and Canada: Technical
the QRA documentation. We received 20993–0002, 301–796–7223.
Report Appendices,’’ 2015. Accessible at
nearly 100 comments on the draft QRA http://www.fda.gov/Food/FoodScience SUPPLEMENTARY INFORMATION:
and have revised the QRA where Research/RiskSafetyAssessment/
appropriate (See Refs. 1 to 5). I. Background
default.htm and http://www.fda.gov/
Elsewhere in this issue of the Federal ScienceResearch/SpecialTopics/Peer Sections 735 and 736 of the FD&C Act
Register, we are issuing a notice ReviewofScientificInformationand (21 U.S.C. 379g and 379h, respectively)
requesting comments and scientific data Assessments/ucm079120.htm. establish three different kinds of user
and information that would assist us in 4. FDA and Health Canada, ‘‘Joint Food and fees. Fees are assessed on the following:
understanding potential intervention Drug Administration/Health Canada— (1) Certain types of applications and
measures to reduce the risk of foodborne Santé Canada Quantitative Assessment supplements for the review of human
illness from consumption of cheeses of the Risk of Listeriosis from Soft- drug and biological products; (2) certain
manufactured from unpasteurized milk. Ripened Cheese Consumption in the establishments where such products are
United States and Canada: Risk made; and (3) certain products (section
II. Electronic Access Assessment Model,’’ 2015. Accessible at
736(a) of the FD&C Act). When certain
http://www.fda.gov/Food/
The QRA and related documents are conditions are met, FDA may waive or
FoodScienceResearch/
available electronically on the FDA Web RiskSafetyAssessment/default.htm and reduce fees (section 736(d) of the FD&C
site at http://www.fda.gov/Food/Food http://www.fda.gov/ScienceResearch/ Act).
ScienceResearch/RiskSafety SpecialTopics/PeerReviewofScientific For FY 2013 through FY 2017, the
Assessment/default.htm, http:// InformationandAssessments/ base revenue amounts for the total
www.fda.gov/ScienceResearch/Special ucm079120.htm. revenues from all PDUFA fees are
Topics/PeerReviewofScientific 5. Joint FDA/Health Canada Quantitative established by PDUFA V. The base
InformationandAssessments/ Assessment of the Risk of Listeriosis revenue amount for FY 2013, which
ucm079120.htm, and http:// from Soft-Ripened Cheese Consumption became the base amount for the
www.regulations.gov. in the United States and Canada: Replies remaining 4 FYs of PDUFA V, is
to Public Comments, 2015. Accessible at $718,669,000, as published in the
III. References http://www.fda.gov/Food/ Federal Register of August 1, 2012 (77
The following references have been FoodScienceResearch/
FR 45639). The FY 2013 base revenue
RiskSafetyAssessment/default.htm and
placed on display in the Division of amount is further adjusted each year
http://www.fda.gov/ScienceResearch/
Dockets Management (see ADDRESSES) SpecialTopics/PeerReviewofScientific after FY 2013 for inflation and
mstockstill on DSK4VPTVN1PROD with NOTICES
and may be seen by interested persons InformationandAssessments/ workload. Fees for applications,
between 9 a.m. and 4 p.m., Monday ucm079120.htm. establishments, and products are to be
through Friday, and are available established each year by FDA so that
Dated: July 29, 2015.
electronically at http:// revenues from each category will
www.regulations.gov. (FDA has verified Leslie Kux,
provide one-third of the total revenue to
the Web site addresses in this reference Associate Commissioner for Policy. be collected each year.
section, but we are not responsible for [FR Doc. 2015–18960 Filed 7–31–15; 8:45 am] This document provides fee rates for
any subsequent changes to the Web sites BILLING CODE 4164–01–P FY 2016 for an application requiring
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Document Created: 2018-02-23 10:51:43
Document Modified: 2018-02-23 10:51:43
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Contact | Sherri Dennis, Center for Food Safety and Applied Nutrition (HFS-005), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1914. | |
| FR Citation | 80 FR 46027 |
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