Under mounting criticism from patients, physicians and industry, the Centers for Disease Control and Prevention (CDC) announced it has opened a second period for public comment on its Guidelines for Prescribing Opioids for Chronic Pain, the agency made public in a notice in the Federal Register.

CDC’s draft guidelines will be available on Monday, December 14, 2015, at http://www.Regulations.gov for review and comment. The public comment period opens December 14, 2015 and closes January 13, 2016.

When the CDC first presented its draft guidelines in a webinar, but not through publication on its website or through other communications vehicles, the agency allowed only two days for public comment. That drew a lot of scrutiny.

The CDC was widely criticized for developing the guidelines in secrecy, prompting the Washington Legal Foundation to threaten a law suit, charging that “state governments and the medical community are unlikely to accept any guidelines tainted by charges that they were prepared in secret without meaningful stakeholder input and with the assistance of individuals who have serious conflicts of interest,” the group wrote in a letter to Dr. Tom Frieden, Director for CDC and Dr. Debra Houry, Director of the National Center for Injury Prevention and Control.

Reaction from pain patients and industry has been deafening, with many arguing that the guidelines will further push pain practitioners out of practice, while simultaneously limiting access to opioids for people who need them.

“The fact of the matter is that state & federal law should not decide how my pain is treated. A licensed medical professional who specializes in pain should have the say in my pain management,” commented one reader of National Pain Report.

“All of us are working to establish a new standard of chronic pain care – one that allows healthcare professionals and those living with chronic pain access to the full menu of treatment options, including opioids for those who benefit from them,” said Myra J. Christopher in an email from PAINS Project.

Here are instructions on how to comment, according to the Federal Register:

You may submit comments, identified by Docket No. CDC-2015-0112, by any of the following methods:

Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

Mail:

National Center for Injury Prevention and Control, Centers for Disease Control and Prevention

Attn: Docket CDC-2015-0112

4770 Buford Highway N.E., Mailstop F-63,

Atlanta, GA, 30341

All submissions received must include the agency name and Docket Number. All relevant comments received will be posted without change to http://regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to

http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Arlene I. Greenspan, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention,

4770 Buford Highway

N.E., Mailstop F-63, Atlanta, GA, 30341;

Telephone: 770-488-4696.

CDC will also convene the National Center for Injury Prevention and Control’s Board of Scientific Counselors to review the draft guidelines.

A public conference will be held January 7, 2016, at 9:00 am on a conference call (Dial-In Number: 1-888-395-7561, Participant Code: 3954121).

The conference call will focus on the background for development of the CDC Guideline for Prescribing Opioids for Chronic Pain (Guideline) and the formation of the Prescribing Opioids for Chronic Pain Workgroup (Opioid Guideline Workgroup).

Public comments will be accepted, but only related to the formation of the Opioid Guideline Workgroup. There will be 30 minutes allotted for public comments at the end of the session. All public comments will be limited to two-minutes per speaker.

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