Posts Tagged 'participate'

Bits and pieces

Many thanks to all those who have written to Tell Dr. Collins to Stop P2P

If you have not already done so, fax or email Dr. Francis Collins today and request that he cancel the P2P Workshop.

Details here http://www.occupycfs.com/2014/06/02/tell-dr-collins-to-stop-p2p/

Additional information about P2P:

http://www.occupycfs.com/?s=P2P

A parallel action to contact Congressional officials about P2P will be released shortly.

WEGO Health Twitter chat about advocating for oneself while living with a stigmatized chronic disease. Hosted by Jennie Spotila

Date: Tuesday, June 10th

Time 3-4pm (Eastern time).

Details http://www.occupycfs.com/2014/06/08/twitter-chat/

The next meeting of the Chronic Fatigue Syndrome Advisory Committee (CFSAC)

Monday afternoon (12-5pm Eastern time) June 16th and Tuesday June17th (9am-5pm Eastern time).

The meeting will be live-video streamed at http://www.hhs.gov/live . (Registration to attend in person ends June 12th. Details https://www.federalregister.gov/articles/2014/05/29/2014-12371/meeting-of-the-chronic-fatigue-syndrome-advisory-committee )

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ME(cfs) International Awareness Day

 

Make time today to honor of all patients who suffer daily with this wretched illness.

 

Most patients are too impaired to advocate.

So our plea is to those with better health,

PLEASE make more time regularly to help patients.

IOM Meeting Monday May 5th

The 3rd meeting for the IOM Diagnostic Criteria for ME/CFS project is Monday May 5th.

Location: National Academies of Science Building 2101 Constitution Ave NW, Washington, DC 20418 (This is a different location than the January meeting.)

Time: 1pm- 5:30pm (the agenda lists the meeting as lasting until 5:30 though the FAQs lists it as ending earlier).

Webcast link: http://www.iom.edu/Activities/Disease/DiagnosisMyalgicEncephalomyelitisChronicFatigueSyndrome/2014-MAY-05.aspx

Agenda link: http://www.iom.edu/~/media/Files/Activity%20Files/Disease/MECFS/Open%20Session%20Agenda_04%2017%2014.pdf

Additional FAQs: http://www.iom.edu/Activities/Disease/DiagnosisMyalgicEncephalomyelitisChronicFatigueSyndrome/2014-MAY-05.aspx

Remember – at any time during the project you can submit comments to the committee. Send comments to: mecfs@nas.edu

It might be worth referencing IOM MECFS Study in the subject line. All comments become part of the Public Access File.

Reminder – FDA webinar Wednesday (23 April) 1pm eastern time

This webinar is about the Draft Guidance to Industry on Drug Development for ME/CFS (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM388568.pdf)

The webinar will have some Q&A time – so make submit your questions.

Guidance Webinar Online-Access Instructions:

To access this webinar, follow the link provided below. Audio will broadcast from your computer speakers.

After following the link, enter as a guest and provide your FULL NAME and organization (i.e. “John Smith – FDA/CBER”). The host will then allow you to enter. If you experience technical difficulties email Jeffery.Rexrode@fda.hhs.gov for assistance. Closed captioning will be provided. Questions/Comments can be submitted live via a Q/A chat window.”

http://www.fda.gov/Training/GuidanceWebinars/ucm392577.htm

In your public comment on the Draft Guidance (due 12 May 2014), consider including the positives in the guidance as well as concerns you may have.

Submit your written comments to the docket (Docket No. FDA-2014-D-0264 ) http://www.regulations.gov/#!searchResults;rpp=25;po=0;s=FDA-2014-D-0264;fp=true;ns=true

FDA Webinar, chance for Q&A and comments April 23, 2014

FDA is hosting a webinar about the draft guidance document “Guidance for Industry Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis: Developing Drug Products for Treatment”.

Note: the webinar will be close-captioned and there questions/comments can be submitted in real-time using a chat window. (It is safe to assume that personal information should not be submitted as this would then be available for all to see onscreen.)

Public comment on the draft guidance should also be submitted to the docket DOCKET NUMBER: FDA–2014–D–0264 http://www.regulations.gov/#!docketDetail;D=FDA-2014-D-0264 – as it then becomes part of the public record.

FDA’s Guidance Webinar series aims to foster collaboration and transparency in the development of guidance documents through direct outreach to affected stakeholders.” (http://www.fda.gov/Training/GuidanceWebinars/default.htm)

FDA Webinar: Guidance for Industry Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis: Developing Drug Products for Treatment – April 23, 2014

The Office of Medical Policy (OMP) in CDER presents another in a series of webinars on 60-day guidances for industry on Wednesday, April 23, 2014 from 1PM – 2PM EDT. The topic is “CHRONIC FATIGUE SYNDROME”.

Guidance for Industry Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis: Developing Drug Products for Treatment

FR NOTICE

PUBLICATION DATE:  03/11/2014

COMMENTS [DUE] DATE:  05/12/2014

DOCKET NUMBER: FDA–2014–D–0264 http://www.regulations.gov/#!docketDetail;D=FDA-2014-D-0264

SPEAKERS:

Janet Maynard, MD and others

Medical Officer

Division of Pulmonary, Allergy, and Rheumatology Products

Office of New Drugs

CDER/FDA

SUMMARY: This guidance is intended to assist sponsors in the development of drug products for the treatment of chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). This guidance focuses on specific drug development and trial design issues that are unique to the study of CFS/ME and on the FDA’s current thinking on how effective treatments can be developed for CFS/ME. The points discussed in this guidance may not be applicable to all drug products. The FDA encourages sponsors to design clinical programs that fit their particular needs and to discuss their planned approach with the Division of Pulmonary, Allergy, and Rheumatology Products (DPARP).

For questions concerning the webinar, please contact Marsha Holloman (301-796-0731)

Webinar information on FDA’s Web site: http://www.fda.gov/Training/GuidanceWebinars/default.htm

______________________________________________________________

Guidance Webinar Online-Access Instructions:

To access this webinar, follow the link provided below. Audio will broadcast from your computer speakers.

After following the link, enter as a guest and provide your FULL NAME and organization (i.e. “John Smith – FDA/CBER”). The host will then allow you to enter. If you experience technical difficulties email Jeffery.Rexrode@fda.hhs.gov for assistance. Closed captioning will be provided. Questions/Comments can be submitted live via a Q/A chat window.

Access link: https://collaboration.fda.gov/gfiwebinar

http://www.fda.gov/Training/GuidanceWebinars/ucm392577.htm

Contacting Congressional Representatives – Call to Action

There is an action to push for $7 to $10 million for an RFA (see below for definition) — This would be NIH money specifically to fund ME(cfs) research. (Yes, we need more than that but this request is in line with CFSAC recommendations and the effort is already underway. We can continue to work on getting more.)

1) This link is to a “Dear Colleague” letter and asks Congressional Members to join Reps. Lofgren (San Jose) and Anna Eshoo (Mountain View, Palo Alto) in raising awareness about ME/CFS among Congress. This is important because such letters signal to other politicians what interests some politicians have and are used for “trading favors” when it comes to voting/ supporting certain things. https://dl.dropboxusercontent.com/u/57025850/Dear%20Colleague%202%20-%20letter%20-%20March%202014.pdf

2) This link is to a letter, signed by 11 Congressional Members, that asks Dr. Collins for $7-$10 million to be earmarked for ME/CFS research. (Currently no funds are specifically set aside for ME/CFS research each year.) https://dl.dropboxusercontent.com/u/57025850/Congressional%20letter%20-%20Dr.%20Collins%20-%20March%202014.pdf

What can you do? 

Start by reading the letters.

1) If your Congressional Rep. has signed the letter, contact them and THANK them for their support. Something as simple as “Thank your for your attention to and support of research into the medical condition myalgic encephalomyelitis/ chronic fatigue syndrome (ME/CFS).” They get little positive feedback so everything helps. Please thank Dr. Gutman for starting this at ben.gutman@mail.house.gov. It’s extra good if you’re Rep. Lofgren’s constituent but even if you’re not, that counts too.

 

2) If your Congressional Rep. has NOT signed, contact them and ask them to do so. Remember that peer pressure works on them as it does for other people. Seeing their colleagues sign helps. If your relatives or friends who live outside your area can send it to their Congressional members, that helps as well. More signatures = more power.

Congressional contact info can be found via this link http://www.contactingthecongress.org/).

Before you do call or write, plan out what you want to say.

Tell them (write) you are a constituent (i.e. you vote in their district), tell a bit of your story (perhaps 5 minutes), why research is important to you, and ask the Congress person to read and considering signing both letters. Do not be put off by speaking to staff only and not the Congress person; staff are influential. Remember also, they work for you so don’t be shy!

Online forms for many Congressional offices do not provide for attaching documents . Since you need to attach the Dear Colleague letter and the letter to Dr. Collins it probably is best to call and ask for an email address (unless you already have one).

Let them know that you will follow-up in 2-3 weeks to find out if the Congress(wo)man has signed or not.

Ask them to forward a paper copy of the signed letter to you if possible and report to speakupaboutme AT gmail DOT com who signed – name, state, Congressional district. If they did not sign, remember to politely ask why and post the reason along with the Rep.’s name.

Make a note on your calendar to follow-up in 2-3 weeks.

If they sign please be sure to thank them for doing so.

FYI (and in case they ask)
Congressional Reps who have already signed:
Anna Eshoo (Mountain View, Palo Alto, Saratoga, along the coast)
Zoe Lofgren   (most of San Jose)
Mike Honda (
Sunnyvale, Cupertino, Santa Clara, Fremont, Newark, North San Jose, and Milpitas)
John Garamendi (Sacramento, Fairfield)
Sheila Jackson Lee (Texas, Houston)
Suzan Delbene (King County, Washington)
Eric Swalwell (Los Gatos, Cupertino, San Jose parts)
Scott Peters (San Diego, Poway)
Daniel Lipinski (Chicago suburbs, Illinois)
John Lewis (this is *the* John Lewis, the Civil Rights leader, from Atlanta, GA)
Eleanor Holmes Norton (Washington, DC)

Request for Application (RFA)

An RFA is a formal statement that solicits grant or cooperative agreement applications in a well-defined scientific area to accomplish specific program objectives. An RFA indicates the estimated amount of funds set aside for the competition, the estimated number of awards to be made, whether cost sharing is required, and the application submission date(s). For cooperative agreements, the RFA will describe the responsibilities and obligations of NIH and awardees as well as joint responsibilities and obligations. Applications submitted in response to an RFA are usually reviewed by a Scientific Review Group (SRG) specially convened by the awarding component that issued the RFA.

http://grants.nih.gov/grants/glossary.htm#R11

To contact your member of Congress: http://www.contactingthecongress.org/

https://dl.dropboxusercontent.com/u/57025850/Dear%20Colleague%202%20-%20letter%20-%20March%202014.pdf

https://dl.dropboxusercontent.com/u/57025850/Congressional%20letter%20-%20Dr.%20Collins%20-%20March%202014.pdf

You might consider attaching this for your Congress(wo)man and staff to read:

http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM368806.p

May 5th 2014 Public Meeting of the Institute of Medicine committee on Diagnostic Criteria for ME/CFS

FROM THE IOM LISTSERV

The third meeting of the Institute of Medicine committee on Diagnostic Criteria for ME/CFS will be held May 5-6, 2014 in Washington, D.C. On the afternoon of May 5, the committee will hold an information-gathering session that will be open to the public. Interested individuals will be able to attend the open session in person at the National Academies of Science building or virtually via webcast.

This open session is one of the many processes that the committee will use to gather information and assemble evidence that it will examine and discuss in the course of making its findings, conclusions, and recommendations. The objectives for the committee during this open session are to learn more about the cognitive, sleep, and diagnostic issues related to ME/CFS; and to seek input from patients and caregivers regarding their interaction with health care professionals.

If you would like to provide written comments to the committee for this meeting, please focus your comments on responses to the following questions:

1) In your opinion, what are the most important issues that healthcare providers should be educated about when it comes to diagnosis of ME/CFS?
2) What are your thoughts on the current terminology used to describe this disease: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome? If you could suggest new terminology, what would you suggest and why?

Please use the email mecfsopensession@nas.edu to submit your written comments. Written comments received by April 23, 2014, will be distributed to the committee before the meeting on May 5. After April 23, written comments should be sent to the project email address (mecfs@nas.edu). All comments will be considered by the committee, but those received after the April 23 deadline may be distributed after the meeting is adjourned. As with any information sent to inform the committee, all written comments will be placed in a Public Access File in compliance with Section 15 of the Federal Advisory Committee Act.

Registration for the open meeting will open shortly and more information, including a tentative agenda, will be posted on this website as it is available.”

PLEASE NOTE THAT THIS MEETING IS BEING HELD IN A DIFFERENT LOCATION (NOT WHERE THE JANUARY MEETING WAS HELD)

The National Academy of Sciences Building

Room 120  NAS Floor Plan

2101 Constitution Ave, NW
Washington, DC

 

DIRECTIONS CAN BE FOUND HERE: http://www.iom.edu/About-IOM/Visit-IOM/Directions-NAS.aspx

FAQs http://www.iom.edu/Activities/Disease/DiagnosisMyalgicEncephalomyelitisChronicFatigueSyndrome/2014-MAY-05.aspx

OTHER INFO http://www.iom.edu/Activities/Disease/DiagnosisMyalgicEncephalomyelitisChronicFatigueSyndrome.aspx