IRS Asks for OMB Approval of Orphan Drug Credit Form

To obtain copies of the submission, call Garrick Shear at (202) 622-3869. Address comments, which are due by December 27, 1999, to Garrick Shear, Internal Revenue Service, Room 5571, 1111 Constitution Ave., NW, Washington, DC 20202; and Alexander T. Hunt, Office of Management and Budget, Room 10202, New Executive Office Bldg., Washington, DC 20503.

November 19, 1999.

[1] The Department of Treasury has submitted the following public information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104- 13. Copies of the submission(s) may be obtained by calling the Treasury Bureau Clearance Officer listed. Comments regarding this information collection should be addressed to the OMB reviewer listed and to the Treasury Department Clearance Officer, Department of the Treasury, Room 2110, 1425 New York Avenue, NW., Washington, DC 20220.

[2] Dates: Written comments should be received on or before December 27, 1999 to be assured of consideration.

Internal Revenue Service (IRS)

[3] OMB Number: 1545-1505.

[4] Form Number: IRS Form 8820.

[5] Type of Review: Extension.

[6] Title: Orphan Drug Credit.

[7] Description: Filers use this form to elect to claim the orphan drug credit, which is 50% of the qualified clinical testing expenses paid or incurred with respect to low or unprofitable drugs for rare diseases and conditions, as designated under section 526 of the Federal Food, Drug, and Cosmetic Act.

[8] Respondents: Business or other for-profit.

[9] Estimated Number of Respondents/Recordkeepers: 100.

[10] Estimated Burden Hours Per Respondent/Recordkeeper:

Recordkeeping -- 6 hr., 13 min. Learning about the law or the form -- 1 hr., 0 min. Preparing and sending the form to the IRS -- 1 hr., 8 min.

[11] Frequency of Response: Annually.

[12] Estimated Total Reporting/Recordkeeping Burden: 836 hours.

[13] Clearance Officer: Garrick Shear, Internal Revenue Service, Room 5244, 1111 Constitution Avenue, NW., Washington, DC 20224.

[14] OMB Reviewer: Alexander T. Hunt (202) 395-7860, Office of Management and Budget, Room 10202, New Executive Office Building, Washington, DC 20503.

Mary A. Able,