June 06, 2008
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
RE Docket 2008-D-0224, April 18, 2008, Draft Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff: Certifications to Accompany Drug, Biological Product, and Device Applications/ Submissions: Compliance With Section 402(j) of the Public Health Service Act, Added by Title VIII of the Food and Drug Administration Amendments Act of 2007
Dear FDA Dockets Manager:
AABB is an international association dedicated to advancing transfusion and cellular therapies worldwide. Our members include more than 1,800 hospital and community blood centers and transfusion and transplantation services as well as approximately 8,000 individuals involved in activities related to transfusion, cellular therapies and transplantation medicine. For over 50 years, AABB has established voluntary standards for, and accredited institutions involved in, these activities. AABB is focused on improving health through the advancement of science and the practice of transfusion medicine and related biological therapies, and developing and delivering programs and services to optimize patient and donor care and safety.
AABB is responding on behalf of the Coalition for Blood Safety Task Force on Licensing, staffed with industry experts on the submission of Biological License Applications. The Task Force, consisting of representatives from AABB, American Red Cross, America’s Blood Centers, Department of Defense, and Plasma Protein Therapeutics Association appreciates the opportunity to comment on the draft “Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff: Certifications to Accompany Drug, Biological Product, and Device Applications/ Submissions: Compliance With Section 402(j) of the Public Health Service Act, Added by Title VIII of the Food and Drug Administration Amendments Act of 2007”.
We applaud the FDA for recognizing and acting expeditiously in publishing a guidance clarifying that not all drug, biological product, and device applications/submissions require accompanying certifications as stated in the new provision of the Public Health Services Act. The proposed list of the types of submissions of information or documents that do not typically require the submission of a certification will provide much needed clarification for establishments and FDA staff alike. Even though the draft guidance document states that the list is not all inclusive and will be modified over time, we recommend that this initial list be expanded to include the following types of submissions:
AABB strongly supports initiatives that improve the safety of patients and donors and stand ready to interact with FDA as necessary.
Please direct all questions regarding these comments or requests for additional information, to myself at 301-215-6515 or firstname.lastname@example.org
- Establishment’s Annual Report
- All submissions types related to a BLA, since these products are not part of a clinical trail and would not be required to submit data to the clinical trials data bank
- Comparability Protocols
- 21 CFR 640.120 variance requests, in particular donor reentry requests
- Submissions for the approval of product labels
In several paragraphs of the draft guidance, Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) was referenced with regard to information concerning certain clinical trails that should be submitted to the clinical trails data bank, thus requiring a certification to be submitted. In order for establishments to review the reference and determine if a submission is subject to this provision, it would be beneficial to provide a link in the guidance document to the specific information.
Joseph L. Giglio, MS, MT(ASCP)SBB, CSQE(ASQ)CQA
Deputy Director Regulatory Affairs, AABB