From: McBride, Richard, LtCol, USAF/SGXW [Richard.McBride@pentagon.af.mil] Sent: Friday, June 21, 2002 3:50 PM To: 'fdadockets@oc.fda.gov' Subject: comments on streamlining the donor interview process FDA: The Air Force Blood Program Office submits the follwing comments in reference to draft guidance for industry entitled "Streamlining the Donor interview Process: Recommendations for Self-Administered Questionnaires MEMORANDUM FOR DOCKETS MANAGEMENT BRANCH (HFA-305) FOOD AND DRUG ADMINISTRATION 5630 Fishers Lane, RM 1061 ROCKVILLE MD 20852 FROM: HQUSAF/SGXW SUBJECT: Comments on Draft Guidane for Industry Streamlining the Donor Interview Process: Recommendations for Self-Administered Questionnaires (Federal Register: 22 Jun 02, Volume 67, Number 77, Docket Number 02D0080) We have reviewed the draft guidance concerning streamlining the donor interview process with recommendations for self-administered questionnaires and provide the following comments for your consideration. Overall, we concur with the intent of the draft guidance and applaud the agency's commitment to improving the efficiency and effectiveness of the donation process. It is our belief that self-administered high-risk behavior questions will be just as effective as orally delivered and relieving our donor centers of that burden will in fact improve the overall safety of the blood supply by reducing demands on our limited blood collection staff resources. We are concerned, however, with a specific recommendation for manual procedures listed in paragraph III.A.4 that states "You should not allow new donors to self-administer the donor questionnaire." Such a broad statement would now apply to the health history as well as the high risk questions and stands to completely change the way donor screening is accomplished. It has been a long-standing, common practice in military and civilian donor centers to instruct donors on the proper completion of the health history, after which the donor read and answers the questionnaires. We believe this practice to be safe and effective as evidenced by our low number of post-donation information reports. Due to the mobile nature of the military population, the majority of our donors may donate only once or a few times at each donor center. Enactment of such restrictive requirements as proposed would have a serious negative impact on the efficiency of our donor screening personnel and processes, and hence the safety and availability of the blood supply with little, if any, benefit gained. Request this statement either be removed or modified to apply only to high risk screening process. Respectfully, Richard H. McBride Jr, Lt Col, USAF, BSC Chief, Air Force Blood Program/SGXW Expeditionary Operations, Science & Technology Office of the Air Force Surgeon General 110 Luke Ave, Room 408 Bolling AFB Washington DC 20332-7050 DSN: 297-5596/0020 Comm: 202-767-5596/FAX: x4841 Home: 301-934-0795