Access to Information Requests Completed - June 2010

This content was archived on June 24, 2013.

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.

For the month of June 2010

Request #	Request text
A-2007-00790	For the Working Group on Aboriginal Health, please provide any records, including but not limited to briefing notes, work plans, minutes of meetings including seating plans, & emails since October 2005 to November 20, 2007. Exclude drafts if the final version is on file. Exclude French translations.
A-2008-00600	Product Monographs (final approved e-versions) for HUMIRA (adalimumab) associated with the following NOC dates: January 23, 2008 November 28, 2007 November 26, 2007 November 23, 2007 July 5, 2007 December 1, 2006 November 20, 2006 October 17, 2006 June 20, 2006 September 24, 2004
A-2008-00617	Enbrel by Immunex Corporation, and distributed by Amgen Canada Inc and Wyeth Canada (for the 2 NOCs dated: May 6, 2005) We would like to obtain a copy of Modules 1 and 2 and all correspondence documents between the sponsor(s) and Health Canada for this submission.
A-2008-00660	Copies of correspondence from Health Canada (TPD or MHPD) to Paladin Labs Inc./Pharmascience Inc.regarding Androderm (DIN 02245972, DIN 02239653) during 2006 or 2007 The correspondence includes a request from Health Canada to Paladin Labs Inc/ Pharmascience Inc. to update their Product Monograph for Androderm, with suggested wording for the updated labeling. We would also like to request any correspondence from Paladin Labs Inc/Pharmascience Inc. in response to this label change request We would consider previously disclosed documentation related to this request.
A-2008-00771	Any and all correspondence and data at the Consumer Product Safety branch related to recall monitoring of the 2007 Mattell toy recalls.
A-2009-00073	Request copies of the following original records for Exetrol Ezetimibe 10 mg Tablets (Merck Frosst-Schering Pharma , GP Manufacturer): Records related to the original ANDS/NDS, supplemental ANDS/NDS, Notifiable Changes: CPID Quality Overall Summary PCERT or CS-BE Reviewer's report Clarifaxes and responses Notice of Compliance Letters of No Objection
A-2009-00255	Request for all correspondence, chemistry and manufacturing, clinical summaries, Quality Overall Summary (QOS), Certified Product Information Document (CPID), Reviewers notes and package labelling for : Estrogel-Schering-Plough Canada Inc.
A-2009-00402	Request for information on a licensed Natural Health Products: 80005825 Triolax Intestins ; Formule I+ ; Triklenz Intestins by Produits Naturels Leblanc Inc. The information requested should include: all regulatory submission related correspondence, all clinical data, all chemistry data, reviewer notes and any other information as it pertains to the approved strengths above.
A-2009-00423	Health Canada signed a Memorandum of Understanding or a data sharing agreement with Brogan INC (a pharmaceutical company) some time between 2005 and 2007. That issue was sharing claim line level data of First Nations and Inuit clients benefit information. This request is for a copy of all paper or electronic correspondence including emails, letters, power points, briefing notes and handwritten notes that demonstrate the events leading to the signing of this MOU/data sharing agreement.
A-2009-00772	NPN submission for Product: Urex-Cap-54 NPN: 80012937 Name of Licensee: CHR Hansen A/S Request that you provide all documentation submitted to support the licensing of this product, including the completed product license application form as well as any documents submitted to establish the safety and efficacy (including species and strain specific identification), quality (including stability testing), chemistry and manufacturing of the product and any associated reviewers notes and reports.
A-2009-00801	Clinical Reviewer's Report regarding approval of Vivaglobin manufactured by CSL Behring Canada Inc Drug Identification Number (DIN) 02282518.
A-2009-00804	All regulatory correspondence relating to the following product: Product Name: Genius Kids and Teens NPN: 80001374 and 80001375 Name of Licensee: Nutripur Inc The request for 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.
A-2009-00809	All regulatory correspondence relating to the following product: Product Name: Mom n' Baby NPN: 80001376 Name of Licensee: Nutripur Inc The request for 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
A-2009-00970	Please provide additional information for the following ADR reports for Revlimid: 000323273; 000317774; 000324228; 000324825; 000323084; 000320538; 000320561
A-2009-01028	All memorandum on consumer products that have been prepared for the Health Minister from Jan. 1, 2009 to Dec. 4, 2009.
A-2009-01122	Obtain the investigation report prepared by Pierre Rousseau, Product Safety Inspector, in relation to an Aromex catalytic diffuser sold by Lembex Import Inc. that was used by the occupant of the premises where the incident occurred on the date cited above. We would like to know whether in his investigation Mr. Rousseau collected debris from the catalytic diffuser or clothing worn by the occupant of the residence and, if so, where we can find the debris if we would like to examine it. We would also like a copy of the photos (on CD) taken or collected by Mr. Rousseau as part of his investigation and any written accounts or handwritten notes that are part of the investigation file..
A-2009-01181	To obtain reviewer's notes of original submission for approved therapies to treat severe allergic reactions. Brand name: Twinject (0.3 mg Auto-Injector / Twinject 0.15 mg Auto-Injector Active Ingredient: Epinephrine solution Schedule: Ethical Single-use auto-injection device Please provide the reviewer's notes for the original submission reviewed by the non-prescription Drugs Evaluation Division.
A-2009-01185	Request for Ropivacaine Re: Naropin Injection Product Monograph and approved labels with NOC dated December 24, 1996 issued to Astra Pharma Inc Product Monograph and approved labels with NOC dated February 15, 2000 issued to Astrazeneca Canada Inc
A-2009-01217	Regarding Health Canada tests on compact fluorescent lamps: Request all results, recommendations and records pertaining to the testing of CFL Light bulbs and their impact on human health.
A-2009-01251	QP notes for : September 22, 2009 H1N1 Flu Vaccine Liability H1N1 (International Aid) H1N1 (Need for Flu Czar) September 24, 2009: PHAC Communications Contracts During H1N1 Outbreak PHAC H1N1 Communications September 28, 2009: Asbestos-chrysotile Marihuana Medical Access - Renewal of the Regulations and Program September 29, 2009: Blood Donor Deferral For Men Who Have Had Sex With Another Man (MSM) Conference Board of Canada, Report Card on Canada
A-2009-01253	QP notes for : October 2, 2009: Contraband Tobacco Products Marihuana Medical Access - Accounts in Arrears Public Service Commission of Canada Audit of Health Canada Hiring Practices Transmission of H1N1 Flu October 5, 2009: Canada's Access to Medicines Regime H1N1 (International Aid) NHP Product Licensing Backlog and Questionable Evidence Push to Prescribe
A-2009-01254	QP notes for : October 6 2009: H1N1 - Lack of Communication October 7, 2009: National Monitoring of Radiologists Across the Country October 8, 2009: National Pharmaceutical Strategy Pandemic Planning and Resources Supply of Medical Isotopes
A-2009-01260	All records related to enclosed recall of mood rings, from November 1, 2008 to May 30, 2009.
A-2009-01262	For the ANDS pertaining to Novo-Methylphenidate ER-C: All correspondence between Health Canada and the sponsor Clinical Study Reports for all bioequivalence studies, including attachments and appendices Comprehensive Summary; Bioequivalence (CS-BE)
A-2009-01267	Request for information regarding the following product: NPN 80012937 Product Name - Urex-Cap-5 Company - CHR, Hansen A/S Please provide all regulatory submissions related correspondence, all clinical data, all safety data, all chemistry data, reviewer's notes and other related information as it pertains to the product listed above.
A-2009-01283	Access to general information submitted to the Medical Devices Bureau by or on behalf of the manufacturer Polymedco Inc, in connection with the Application for New Medical Device Licence for the medical device BTA Stat Test (Device Identifier No. 661010), for which was issued on February 28, 2003. This request includes all information submitted by or on behalf of Polymedco Inc and any and all follow-up correspondence and submissions related to the application
A-2009-01304	Please provide all information that was submitted to Health Canada that led to the approval of the product PMS Cholestyramine Regular PWD 4 G/9 G (DIN 02210320 by Pharmascience Inc.) including modules 1 and 2., and all correspondence to and from Health Canada in regards to the submission
A-2009-01323	For a list and copy (electronic) of all consulting and research contracts awarded since January 1, 2008 dealing with tobacco packaging and warning labels required on tobacco products as mandated by the Tobacco Act. For greater certainty, interested in a copy of any consulting contracts and research contracts that deal specifically with increasing the size of the current health warnings on tobacco products as required by the regulations promulgated under the Tobacco Act. For a copy of all work product completed as a result of the awarding of any contracts covered above - awarded after January 1, 2008. This work product will include studies that contribute to any policy rationale for increasing the size of health warnings and/or the percentage of the packaging covered by said warnings.
A-2009-01328	Request copies of all correspondence and regulatory submissions (ANDS) pertaining to Novopharm's generic lansoprazole drug submission including all correspondence between Novopharm and the Minister of Health, safety requirements, bioequivalence submissions and draft product monograph.
A-2009-01342	Any document detailing the pieces of children's jewellery found to contain cadmium for the period of 2009 to present (March 2, 2010).
A-2009-01390	For the period from 2007 to 2010. Per Quarter, would want the sales of: Cigar (In Sticks), Snuff (in Kilo), Chewing Tobacco (in Kilo). For the same products would also need the importations in Canada and exportations from Canada per quarter.
A-2009-01396	Request includes both GEN-nifedipine and/or MYLAN-nifedipine. A check of the drug product and NOC database indicated that the DIN is the same for both. (i) Our client is most concerned with regard to post-marketing adverse events. As this is an update of our prior request, we assume that this can be done fairly quickly. (ii) With regard to information regarding submission -related information, our client would also like this information, to the extent that such information was not provided in our prior ATI requests - Health Canada File Nos.A-2009-00745; A-2009-00746; and A-2009-00747. However, we do not want this to delay the delivery of information under (i) above. So to the extent including this information may delay delivery of information under (i) above, please attend to (i) first and then (ii) A-2009-00745 reads as follow: This request relates to a once daily nifedipine product for which Mylan Pharmaceuticals ULC holds DIN 02321149 and Genpharm ULC holds Notices of Compliance (hereafter Gen-nifedipine). Specifically we request all information under Health Canada's control relating to any reports of adverse events in any person taking Gen-nifedipine. This request includes any and all such information whether submitted to Health Canada, collected by Health Canada, or generated at Health Canada including internal information, communications, correspondence, documents, records and reports. A-2009-00746 reads as follow: This request relates to a once daily nifedipine product for which Mylan Pharmaceuticals ULC holds DIN 02321149 and Genpharm ULC holds Notices of Compliance (hereafter Gen-nifedipine). Specifically we request all information under Health Canada's control relating to Gen-nifedipine or to any submission for a notice of compliance for Gen-nifedipine. This request includes any and all such information submitted to Health Canada or collected by Health Canada as well as internal information, communications, correspondence, documents, records and reports whether comprising or relating to the drug submission for the above-noted product, its review and approval or not and any amendments to any such submission or information. A-2009-00747 reads as follow: This request relates to a once daily nifedipine product for which Mylan Pharmaceuticals ULC holds DIN 02321149 and Genpharm ULC holds Notices of Compliance (hereafter Gen-nifedipine). Specifically we request: 1) all information under Health Canada's control relating to any comparison (including bioequivalence between) Gen-nifedipine and Bayer's ADALAT XL. 2) all information under Health Canada's control relating to measurement of serum levels of nifedipine in humans given Gen-nifedpine and any measured or calculated pharmacokentic parameters for Gen-nefidipine including but not limited to Cmax, Cmin, Tmax, AUC (by any method) whether absolute or relative, including all statistical analysis and results; and 3) all information under Health Canada's control relating to any dissolution testing of nifedipine. This request includes any and all such information submitted to Health Canada or collected by Health Canada, or generated at Health Canada including internal information, communications, correspondence, documents, records and reports.
A-2009-01436	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: Licence Number - Product Name - Licence Holder 80003090 - Solaray Dong Quai 500 mg - Au Naturel Inc.
A-2009-01437	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: Licence Number - Product Name - Licence Holder 80013802 - Dong Quai - Regime Industries Ltd
A-2009-01449	Copy of all documents and correspondence between Health Canada and Norgil Canada for: Licence Number - Product Name - Licence Holder 80013396 - Alpharequl - Norgil Canada
A-2009-01456	Health Canada - HPFBI Inspection Reports issued to Apotex, 150 Signet Drive, Weston Ontario, M9L 1T9 during 2008 and 2009.
A-2010-00006	Novo-methylphenidate ER-C and all strengths of the product. Request copies of all records originating from Health Canada and sent to a third party that relate to whether Health Canada should approve, or should have approved
A-2010-00007	Novo-methylphenidate ER-C and all strengths of the product. Request copies of all records originating from Health Canada and sent by a third party that relate to whether Health Canada should approve, or should have approved.
A-2010-00036	Pegalax DIN: 02308232, by Medical Futures Inc, Health Canada approved labelling and prescribing information.
A-2010-00054	Copies of any emails from the Director General's Office of TPD on March 26, 2010 pertaining to the issuance of HPFB awards.
A-2010-00057	Request the following information in relation to the First Nations and Inuit Health (FNIH) - Health Canada - Pacific Region (British Columbia), under the Access to Information Act. Provide the following information as it relates to EX bonuses paid within the FNIH - Health Canada - Pacific region. All EX performance bonuses paid to employees within First nations and Inuit Health - Health Canada - Pacific Region (British Columbia), in relation to the following years. 2000, 2001, 2002, 2003, 2004, 2005, 2006, 2007, 2008, 2009, 2010 Specifically the bonuses paid to the following positions: Regional Director General - FNIH - Health Canada - Pacific Region (British Columbia) Assistant Regional Director General - FNIH - Health Canada - Pacific Region (British Columbia) Regional Director - FNIH - Health Canada - Pacific Region - (British Columbia) Director - Health Transfer & Tripartie Health plan - FNIH - Health Canada - Pacific Region British Columbia) during the above requested time period. Any other employee bonuses paid within FNIH - Health Canada - Pacific Region (British Columbia) during the above requested time period Please include the classification title, amount of performance bonus received including which year, for each position that received bonus pay during the above requested time period..
A-2010-00091	Seeking access to two reports created by Health Canada's Health Surveillance and Data Analysis Unit, First Nations and Inuit Health Branch, Alberta Region: The first document is not dated, but we believe it was created in or around October of 2006. It is entitled "Physician Profile Report, Prepared for Mr. Tyler White, Siksika First Nation". The second document is dated October 31, 2006 and is titled "Confidential Summary for Tyler White, Health Director, Siksika Nation".
A-2010-00105	Documents pertaining to vaccine identified as Haemophilus influenzas type b (Hib) lyophilised (freeze dried) version that was distributed under the band name Act-HIB (Pasteur-Mérieux, distributed in Canada by Connaught Laboratories Ltd) The information requested: the Product monograph, the license or Din number of this vaccine in its monovalent version and year of introduction, Secondly authorisation document or licensing permits for this Act-Hib lyophilised version to be used with Penta (1994-1998) and Pentacell (1998-2002) vaccine.
A-2010-00142	Previously disclosed records under A-2005-01602 A-2005-01602 reads as follows: Copy of hardcopy or electronic documents related to clinical trial inspections (preparations thereof, actual conduct, and reporting thereof) such as checklists, templates, forms, standard letters, procedures, work practices, guidance's or equivalent documents, created since 2002 to present. Mostly interested in documents or internal processes that have not been made publicly available for consultation.
A-2010-00157	All reviewer reports for all stages of review for the NDS for Flovent HFA (DINs 02244291, 02244292 & 02244293)
A-2010-00159	A listing of the ATI requests submitted to Health Canada for the period of April 1, 2010 to April 30, 2010 The information requested should include the Health Canada number for the request, the name and type of agency that requested the information, the date of the request, and a description of the request.
A-2010-00178	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: April 2010.
A-2010-00180	Information regarding Health Canada vehicles and vehicle repairs from the Regina Region only. Please provide invoices, estimates or/and working orders pertaining to windshield repairs on Health Canada vehicles. The timeframe is from January 1. 2008 to present(May 12, 2010)
A-2010-00190	The original DIN application for Squire Laboratories' Stress-Dex (DIN# 00548901)
A-2010-00193	Provide the number of Special Authorization Program (SAP) authorizations for the following: Dacogen (decitabine) ESAI; Reporting Period: 8 May to 14 May 2010
A-2010-00205	Callup documents for January, February, March 2010 for SO + SA temp help
A-2010-00208	Provide the number of Special Authorization Program (SAP) authorizations for Dacogen (decitabine) ESAI from 15 May to 21 May 2010
A-2010-00209	Provide the number of Special Authorization Program (SAP) authorizations for Dacogen (decitabine) ESAI from 22 May to 28 May 2010
A-2010-00217	Request any document detailing the pieces of children's jewellery found to contain cadmium for the period of 2009 to March 2010
A-2010-00221	Listing of all term appointments (casual appointment) in the National Capital Region in 2010. Please include employee name (last name, initial of first), job title, employee class, start date, appointment effective date and end date
A-2010-00223	A listing of any documents made under the Access to Information Act between June 16, 2006 and the present date, for documents o information of, about, submitted by or in relation to any drug submissions to any drug submissions filed by Bristol-Myers Squibb Canada for entecavir or BARACLUDE, including the date of the request and the wording of the request, but not including the identity of the requester
A-2010-00245	Hardware and Software inventories for equipment placed with the FN Epicentre or IICHI
A-2010-00254	Provide the number of Special Authorization Program (SAP) authorizations for Dacogen (decitabine) ESAI from 29 May - 4 June 2010
A-2010-00323	What requests have been made in the past and what requests are pending, relating in any way to the March, 2010 decision by Health Canada to lift the ban on synthetic caffeine in non-cola soft-drinks. This should include any requests dating back to June 1st 1994 that relate to allowing caffeine in non cola soft-drinks