ASIP DRAFT response to the NPRM Common Rule

November 18, 2015
Dear Colleagues,
The ASIP Research and Science Policy Committee has prepared its response to the Notice of Proposed Rule Making for the Common Rule.  It is currently in DRAFT form, since it has not been formally approved by the ASIP Council.  However, since comments are due December 7, we wanted to give you sufficient time to review our comments.  We urge you to submit your own comments by December 7.  Feel free to excerpt sections of this letter in your own response.  We also encourage you to  forward our letter to other interested parties.  If you agree with it in its entirety, you may attach our response to a cover letter of your own.
Please note the following:  The NPRM posed 88 questions.  We chose to answer only those most directly related to biospecimens and just a few others.  Since each question is read by a different group of reviewers at DHHS, we repeated ourselves many times and started each question with our full name, etc.  Therefore the letter is very long and repetitious on purpose.
The letter is in 3 parts:
1.Pages 1-4:  the cover letter
2.Pages 5-15: answers to specific questions posed in the NPRM
3.Pages 16-17: Appendix A – Problematic Cost Assumptions – this may indeed be the most important section, since we are challenging the cost assumptions of the NPRM and the Office of Management and Budget must rule on cost assumptions of all proposed rules.
In addition to our DRAFT LETTER, attached is Appendix B (referred to in our response), ASIP’s letter to SACHRP concerning return of research results and lack of harmony between HIPAA and CLIA.
We expect that the ASIP Council will formally endorse this letter on November 23.  We will keep you informed when the letter is formally accepted by ASIP Council.  PLEASE LET ME KNOW IF YOU WOULD LIKE US TO PROVIDE YOU WITH A CLEAN COPY OF THE FINAL LETTER to facilitate your own response.    
HOT TO SUBMIT COMMENTS: 
1.Identify your comments by Docket ID number HHS-OPHS-2015-0008
2.Electronic submission:  Federal eRulemaking Portal:  http://www.regulations.gov.  Enter the docket ID in the “Enter Keyword or ID” field and clickon Search.  On the next webpage, click on “Submit a Comment” action and follow the instrucitons.
3.Mail or Hand delivery/Courier: to Jerry Menikoff, MD, JD, OHRP, 1101 Wootton Parkway, Suite 200, Rockville MD 20852
4.Comments will be posted on http://www.regulations.gov
If you have any questions, please contact me.
Mark
Mark E. Sobel, MD, PhD
Executive Officer, ASIP
9650 Rockville Pike
Bethesda, MD 20814
Tel: 301-634-7130301-634-7130
Fax: 301-634-7990
email: mesobel@asip.org

ASIP final letter to SACHRP on CLIA-HIPAA 6_23_15
ASIP draft Common Rule NPRM letter 11_10_15