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Access to Information Requests Completed - July 2010

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The following is a list of Access to Information requests processed by Health Canada. The list is not all-inclusive. Requests such as those that did not result in the release of any records or that contain primarily personal information are not posted.

If you wish to obtain a copy of the records released in response to these requests informally, you may contact the Access to Information and Privacy Division.

ACAN
Advance Contract Award Notice
AER
Adverse Reaction Report (Adverse Event)
ANDS
Abbreviated New Drug Submission
ATI
Access to Information
CFL
Compact fluorescent lamp / light
DIN
Drug Identification Number
EMF
Electric and Magnetic Fields
HPFB-I
Health Products and Food Branch Inspectorate
ID
Identification
MG / Mg / mg
Milligram(s)
MHPD
Marketed Health Products Directorate
NDS
New Drug Submission
NHP
Natural Health Product(s)
NHPD
Natural Health Products Directorate
NOC
Notice of Compliance
NPN
Natural Product Number
preNDS / pre-NDS
Pre-NDS (New Drug Submission) Meeting
QP
Question Period
SNDS
Supplement to a New Drug Submission
SOS
Standing Offer Solicitation
TPD
Therapeutic Products Directorate
UV
Ultraviolet

Completed Requests

For the month of July 2010
Request # Request text
A-2007-00641 All documentation pertaining to correspondence between Health Canada and non-governmental organizations and any anti-smoking groups or advocates for more stringent controls over the tobacco industry, for the period of 2000 to present (Oct 5, 2007). Include only those documents which contain an advocacy position, or a direct reference to an advocacy position.
A-2008-00022 Briefing book prepared for the appearance of the Minister of Health at the Standing Committee on Health on June 6, 2006. Briefing books presented for each appearance on that date.  Request limited to specific QP notes
A-2008-00040 Internal analyses, reports prepared by consultants between Health Canada and Environment Canada between January 1, 2001 and December 31, 2007 on the pollution actually and potentially caused by ethanol production and use.
A-2008-00105 All documentation pertaining to an exploratory study prepared by, or on behalf of, Health Canada, regarding discount cigarette smokers in Ontario and Québec. This study included consumers of discount brands as well as contraband and smuggled tobacco.  The study included the involvement of Murray Kaiserman, and was to have been completed by the end of the 2006-2007 fiscal year.
A-2008-00125 Any records of Health Canada that refers to the names of any Health Canada staff working on the BC Supreme court case of PHS Community Society vs Attorney General of Canada from April 21, 2008 to present

Any document or collection of documents of Health Canada that refer to the PHS Community Services Society (PHS) and the Vancouver Area Network of Drug Users (VANDU) being used as a brief, backgrounder, information file, resource document, collection, etc for any Health Canada staff working on the PHS Community Services Society vs Attorney General of Canada BC Supreme Court Case.

Include published material and news articles that you have on file.
A-2008-00212 A list of all ministerial correspondence, briefing notes, 48 hours turn around, QP notes, prepared for the Minister for the period of March 1, 2008 to June 2, 2008.
A-2008-00503 All records given to Health Minister Tony Clement & between Health Canada and Industry (including but not limited to, product associations, and individual companies, or interested individuals - including but not limited to Consumer Groups regarding the implementation of the new product safety legislation announced by the Federal Government on April 8, 2008. Include records dating from January 1, 2007 to April 8, 2008, inclusively.
A-2008-01024 Complete documentation for the Risk Management program, which is briefly outlined on page 5 of the current approved Product Monograph (dated June 27, 2008) for TRAMACET. Provide the "progress reports" that have been sent to Health Canada from the ongoing drug abuse surveillance program, as required by the Product Monograph.
A-2009-00108 All documents relating of referring to requests for exemptions pursuant to section 56 of the Controlled Drugs and Substances Act. I seek only materials related to exemption requests made on the basis of religious and/or spiritual use of controlled substances (whatever the formal basis of the requests: i.e., if a request is made on the basis of scientific, medical or public interest grounds but the genesis of the request is related to religious or spiritual practice or use of the substance, it falls into the parameters of my request).
A-2009-00116 All regulatory submission related correspondence, all clinical data, all chemistry data, reviewer's notes and any other related information for CO ETIDROCAL, DIN 02263866, Manufactured by Cobalt Pharmaceuticals Inc.
A-2009-00251 All minutes of Toy Committee, from September 1, 2008 to May 22, 2009.
A-2009-00339 Information regarding the drug product, Twinject 0.3mg auto-Injector (DIN: 02247310) and 0.15mg auto-Injector (by Paladin Laboratories Inc. Regarding the approval process: Internal Health Canada reviewer notes, external communication between Health Canada officers or reviewers and the DIN owner.
A-2009-00527 Copy of TPD Reviewer's Report for:  Seroquel 25mg (DIN 02236951) Quetiapine fumarate NOC Dated 1997-12-02.
A-2009-00539 The lab report relating to the investigation into the following Shoe Information:
Name: Finroin - 24
Description: Two Tone Brown Leather
Product Code:11-5-2 72813529
Company: ALDO
Lab Technician: Pierre Maurice Damas
Health Canada Rep: Rosa Parks
A-2009-00686 All documents and test results, corrective action related to a study currently underway at Health Canada on "UV radiation and EMF emission levels from CFLs" Study to be completed in early fall.

Three reports :
Ultraviolet Radiation Emissions from Compact Fluorescent Lights, Hazard Evaluation Report.
Report on Health Canada Survey of Electric and Magnetic Fields from Compact Fluorescent Lamps.
Report on Health Canada Survey of Ultraviolet Radiation and Electric and Magnetic Fields from Compact Fluorescent Lamps.
A-2009-00784 Copies of the following records for Bexxar (tositumomab and iodine | 131 tositumomab) manufactured by GlaxoSmithKline for the period January 1, 2003 to December 31, 2008:

Reviewer's Notes and other information related to the clinical, non clinical and quality (chemistry and manufacturing) review of the original NDS and any subsequent sNDSs.

Information Requests/Clarifaxes issued to the sponsor and the respective responses during the review of the NDS and any subsequent sNdSs.

Copies of preNDS meeting briefing package(s), slides and meeting minutes.
A-2009-00805 All regulatory correspondence includes product licence application, safety and efficacy information, quality information, information request notices and responses, processing deficiency notices and responses, record of decision, reviewer's notes for:

Product Name: Centrum Materna
NPN: 80001842
Name of Licensee: Wyeth Consumer Healthcare Inc.
A-2009-00959 Reviewer's comments (Notes and Report), and correspondence with Health Canada regarding PROCYTOX, submission Control # 080233.
A-2009-01079 Requesting a copy of all reviewer reports (e.g. Pharmaceutical Safety and Efficacy Assessment Template (PSEAT), bioequivalence studies etc) for all stages of review for the NDS or SNDS that supported the approval of Oxycontin. The relevant approval dates (NOC issued) are January 4, 1996 (DIN: 02202441, 02202468, 02202476, 02202484), December 16, 2002 (DIN: 02246902), September 23, 2004 (DIN: 02258129) and March 4, 2009 (DIN: 02323192, 02323206, 02323214, 02323222).
A-2009-01288 ACAN / Solicitation #1000100722 please provide the sole source documentation more specifically, a copy of the contract (including rates) and briefing notes.
A-2009-01290 All information regarding these offers including total points scores for each successful supplier, rates offered by each supplier for the term of the standing offer, and annual spent per supplier on the following SOS's and ACAN:

Standing Offer Solicitation # 1000092541 (Issued through Health Canada-ON).
A-2009-01303 All information that was submitted to Health Canada that led to the approval of the ANDS for the product PMS Cholestyramine Light PWD 4 G/5 G (DIN 00890960) by Pharmascience Inc., including modules 1 and 2.
A-2009-01425 Product Licence submission in its entirety including the product licence application form, label text, evidence summary report, references, safety summary report, animal tissue form(s), quality summary report and all the associated information request notices and response of:

Product Name: Now Silica Complex 500 mg
Licence Number: 80006601
Licence Holder: Now Foods
A-2009-01431 Product Licence submission in its entirety including the product licence application form, label text, evidence summary report, references, safety summary report, animal tissue form(s), quality summary report and all the associated information request notices and response of:

Product Name: Greens+ (Natural mixed Berry, Natural Tangerine)
Licence Number: 80010538
Licence Holder: Genuine Health
A-2009-01440 Product Licence submission in its entirety including the product licence application form, label text, evidence summary report, references, safety summary report, animal tissue form(s), quality summary report and all the associated information request notices and response of:

Product Name: Dioscorea Villosa, Wild Yam Root
Licence Number: 80004371
Licence Holder: Natures Formulae Health Products Ltd
A-2009-01441 Product Licence submission in its entirety including the product licence application form, label text, evidence summary report, references, safety summary report, animal tissue form(s), quality summary report and all the associated information request notices and response of:

Product Name: Wild Yam Tincture
Licence Number: 80010961
Licence Holder: St. Francis Herb Farm Incorporated
A-2009-01448 Copy of all documents and correspondence between company below and Health Canada regarding product NPN requests et related NPNs:

Product Name: Ongles & Cheveux (Nails & Hair)
NPN: 80003089
Licence Holder: Vitaminol Inc.
A-2009-01476 Information (original submission documentation, correspondence and reviewer's comments) for the following product:

Product Names: Iscador M Serie Liquid, Iscador P Serie Liquid and Iscador Q Serie Liquid
Licence number: NPN 02232606
Licence holder : Weleda

The licence was issued by NHPD (Health Canada on June 30, 2009).
A-2010-00035 Approved labelling and prescribing information for Restoralax DIN: 02318164, by Schering-Plough Canada Inc.
A-2010-00053 Please provide copies of all documents held by your Department showing the list(s) of all contracts over $10,000 granted by your organization for various types of services and computer equipment from January 1, 2000 to date, April 8, 2010. The documents must show the name of each firm, the value of each contract, the type of contract for services and computer equipment, the date and the year of each contract.
A-2010-00072 Copies of all reports, analyses, and other correspondence (including marginal notations & attached "post-it notes") regarding all inspections and investigations carried out under the new HPFB-I Clinical Trial Inspection Framework.
A-2010-00079 Copies of all complaints and /or subsequent reports or documents concerning an incident at SFBC Anapharm.  Date range September 2005 to present (April 20, 2010).
A-2010-00097 All memoranda prepared for the Minister dealing with Quebec's proposed Health Deductible, contained in the provincial budget of 2010-11. Period of March 20, 2010 to present (April 23, 2010).
A-2010-00218 Please provide any document from Health Canada or its agencies stating the concentration of cadmium in children's jewellery following the Health Canada evaluation completed in March 2010.
A-2010-00231 Original adverse reaction reports by a health professional /layperson received by MHPD for: YASMIN - AER No: 000336652
A-2010-00232 Original adverse reaction reports by a health professional /layperson received by MHPD for:
MIRENA - AER No: 000335909
A-2010-00233 Original adverse reaction reports by a health professional /layperson received by MHPD for:
MAGNEVIST - AER No: 000336594
A-2010-00234 Original adverse reaction reports by a health professional /layperson received by MHPD for:
LEVITRA - AER No: 000336906
A-2010-00235 Original adverse reaction reports by a health professional /layperson received by MHPD for:
CIPRO - AER No: 000336890
A-2010-00256 All call-ups processed by this institution in the National Capital Region under the terms of any standing offer and/or supply arrangement for Temporary Help Services during the period of May 2010.
A-2010-00260 Original adverse reaction reports by a health professional /layperson received by MHPD for:
Yasmin - AER No: 000337961
A-2010-00261 Original adverse reaction reports by a health professional /layperson received by MHPD for:
AVELOX & AVELOX IV - AER No: 000337490, 000337581, 000337977, 000338301, 000338440
A-2010-00262 Original adverse reaction reports by a health professional /layperson received by MHPD for:
CIPRO - AER No: 000338608
A-2010-00263 Original adverse reaction reports by a health professional /layperson received by MHPD for:
DIANE-35 - AER No: 000338528, 000338641
A-2010-00264 Original adverse reaction reports by a health professional /layperson received by MHPD for:
MAGNEVIST - AER No: 000338317
A-2010-00265 Original adverse reaction reports by a health professional /layperson received by MHPD for:
MIRENA - AER No: 000337717, 000337855, 000338843
A-2010-00280 Serious adverse reactions reported with CIPRALEX - AER No: 000331185
A-2010-00281 Serious adverse reactions reported with CIPRALEX - AER No: 000331914
A-2010-00282 Serious adverse reactions reported with CIPRALEX - AER No: 000332526
A-2010-00283 Serious adverse reactions reported with CIPRALEX - AER No: 000332899
A-2010-00284 Serious adverse reactions reported with CIPRALEX - AER No: 000334722
A-2010-00285 Serious adverse reactions reported with CIPRALEX - AER No: 000335455
A-2010-00286 Serious adverse reactions reported with CELEXA - AER No: 000331359
A-2010-00287 Serious adverse reactions reported with CELEXA - AER No: 000331732
A-2010-00289 Serious adverse reactions reported with CELEXA - AER No: 000334019
A-2010-00290 Serious adverse reactions reported with CLOPIXOL - AER No: 000332360
A-2010-00302 All documents such as business impact studies showing actual and/or estimated costs to practitioners and businesses subject to the NHP Regulations.
A-2010-00337 Adverse Drug Reaction reports for suspected drug PANTOLOC (pantoprazole sodium) Report ID: 000336390
A-2010-00338 Adverse Drug Reaction reports for suspected drug Alvesco and Omnaris (ciclesonide). Reports ID: 000335936, 00038915, 000338073
A-2010-00339 Adverse Drug Reaction reports for suspected drug Tecta (pantoprazole magnesium) Report ID: 000335970, 000337178, 000337201, 000338000, 000340056
A-2010-00352 Expense accounts and travel expenses reimbursed to Germain Tremblay by your organization. For 2009-2010 fiscal year..
A-2010-00358 Original adverse reaction reports by a health professional /layperson received by MHPD for:
AVELOX - AER No: 000338835, 000338879, 000339277, 000340165, 000340169, 000340271, 000340283, 000340336, 000340337, 000340446, 000340561, 000340601
A-2010-00359 Original adverse reaction reports by a health professional /layperson received by MHPD for:
YASMIN - AER No: 000339479, 000339595, 000340659
A-2010-00360 Original adverse reaction reports by a health professional /layperson received by MHPD for:
ADALAT XL - AER No: 000340531
A-2010-00361 Original adverse reaction reports by a health professional /layperson received by MHPD for:
CIPRO - AER No: 000339600
A-2010-00362 Original adverse reaction reports by a health professional /layperson received by MHPD for:
CIPRO - AER No: 000338826, 000338853
A-2010-00363 Original adverse reaction reports by a health professional /layperson received by MHPD for:
CLIMARA - AER No: 000338831
A-2010-00364 Original adverse reaction reports by a health professional /layperson received by MHPD for:
DIANE-35 - AER No: 000338953
A-2010-00365 Original adverse reaction reports by a health professional /layperson received by MHPD for:
FLUDARA - AER No: 000339607
A-2010-00366 Original adverse reaction reports by a health professional /layperson received by MHPD for:
MAGNEVIST - AER No: 000339254, 000339834
A-2010-00367 Original adverse reaction reports by a health professional /layperson received by MHPD for:
MIRENA - AER No: 000340473
A-2010-00368 Provide the number of Special Authorization Program (SAP) authorizations for:
Dacogen (decitabine) ESAI from June 5-11, 2010
A-2010-00378 Provide copies of original submission forms used in reporting the following Adverse Reaction Reports to MHPD:
Product: Vidaza
MHPD Reference# 000336201
A-2010-00381 Provide the number of Special Authorization Program (SAP) authorizations for:
Dacogen (decitabine) ESAI from June 12-18, 2010
A-2010-00401 A listing of the ATI requests submitted to Health Canada for the period of May 1-31, 2010.
A-2010-00409 Provide the number of Special Authorization Program (SAP) authorizations for:
Dacogen (decitabine) ESAI from June 19-25, 2010
A-2010-00411 Copies of the approved labelling (outer carton label, inner label and package insert) for LYPRININ (NPN 80012063)
A-2010-00413 A detailed copy of adverse drug reaction for:
DICETEL (pinaverium bromide) tablets. Case # 000326353, 000332047, 000330421
A-2010-00417 A detailed copy of adverse drug reaction for:
LIPIDIL (fenofibrate). Case # 000326486, 000331690
A-2010-00423 Provide the number of Special Authorization Program (SAP) authorizations for:
Dacogen (decitabine) ESAI from June 26 - July 2, 2010
A-2010-00426 Adverse Drug Reaction Report received by the Canada Vigilance Program with the corresponding Canada Vigilance On-line Database AER Number: 000321359
A-2010-00427 Adverse Drug Reaction Report received by the Canada Vigilance Program with the corresponding Canada Vigilance On-line Database AER Number: 000321656
A-2010-00428 Adverse Drug Reaction Report received by the Canada Vigilance Program with the corresponding Canada Vigilance On-line Database AER Number: 000324393
A-2010-00429 Adverse Drug Reaction Report received by the Canada Vigilance Program with the corresponding Canada Vigilance On-line Database AER Number: 000327672
A-2010-00430 Adverse Drug Reaction Report received by the Canada Vigilance Program with the corresponding Canada Vigilance On-line Database AER Number: 000328909
A-2010-00454 All Callups processed by this institution in the National Capital Region under the terms of any standing offer and/or supply arrangement for Temporary Help Services during the period: June 2010.
A-2010-00457 Provide the number of Special Authorization Program (SAP) authorizations for:
Dacogen (decitabine) ESAI from July 3-9, 2010
A-2010-00484 Provide the number of Special Authorization Program (SAP) authorizations for:
Dacogen (decitabine) ESAI from July 10-16, 2010