Blood Donor Letter to Dr. Schwab

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Centers for Disease Control and Prevention

National Center for Health Statistics

3311 Toledo Road

Hyattsville, Maryland 20782

July 31, 2012

Margo Schwab, Ph.D.

Office of Management and Budget

725 17th Street, N.W.

Washington, DC 20503

Dear Dr. Schwab:

The staff of the NCHS Questionnaire Design Research Laboratory (QDRL) (OMB No. 0920-0222, exp. 06/30/2015) plans to continue to conduct research to evaluate the Blood Donor History Questionnaire for the Office of the Assistant Secretary for Health (OASH) in three additional geographic locations (Austin, Texas; Salt Lake City, UT; Mobile, AL/Biloxi, MS). The QDRL received OMB approval to conduct 100 initial interviews in the greater Washington, DC and Baltimore areas and another geographic location outside of the Washington, DC and Baltimore area as described in our letter to you of October 25, 2011 (Attachment 1) for which we received approval to conduct the research on December 8, 2011.

The QDRL is proposing to conduct up to an additional 100 interviews in Austin, Salt Lake City, Mobile/Biloxi using the same recruitment criteria that has been successful in recruiting the first 100 respondents, i.e., adults aged 18 years and over who have ever thought about giving blood, have been deferred from giving blood for any reason, or who have successfully given blood in the past, and men aged 18 years and over who have had sexual contact with another man at least once in their life. In addition, we hope to recruit respondents with demographic variety (particularly in terms of education, race/ethnicity, and income).

All eligibility screening, informed consent, and cognitive interviewing procedures will conform to the procedures outlined in our letter to you on October 25, 2011 and approved on December 8, 2011.

No changes have been made to the instrument, medication deferral list, or the information sheet (Attachment 2) since their approval on December 8, 2011.

No changes have been made to the advertisements or flyers (Attachment 3) since their approval on December 8, 2011.

We propose to continue to pay respondents $50 for their participation, which is $10 over our standard payment. This amount has proved to be successful in recruiting the first 100 respondents by increasing participation, reducing the number of cancelations, and maximizing time and travel in particular geographic locations.

In total, for this additional testing, the maximum respondent burden will be 100 hours of interviewing in addition to travel time. The burden is already accounted for in the generic clearance. An updated burden table for this genIC project is shown below:

Projects	Number of Participants	Number of Responses/ Participant	Average hours per response	Response burden
QDRL Interviews
2) Other questionnaire testing	100	1	1	100

Attachments (3)

cc:

M. Moien

T. Richardson

DHHS RCO

2