# Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Special Protocol Assessment
**AGENCY:**
Food and Drug Administration, HHS.
**ACTION:**
Notice.
**SUMMARY:**
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
**DATES:**
Fax written comments on the collection of information by July 23, 2007.
**ADDRESSES:**
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974. All comments should be identified with the OMB control number 0910-0470. Also include the FDA docket number found in brackets in the heading of this document.
**FOR FURTHER INFORMATION CONTACT:**
Elizabeth Berbakos, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,301-827-1482.
**SUPPLEMENTARY INFORMATION:**
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
**Guidance for Industry on Special Protocol Assessment (OMB Control Number 0910-0470)—Extension**
In the *Federal Register* of July 31, 2006 (71 FR 43199), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received.
| 21 CFR Section | No. of | Annual Frequency per Response | Total Annual | Hours per | Total Hours |
| --- | --- | --- | --- | --- | --- |
| Notification for Carcinogenicity Protocols | 21 | 2.19 | 46 | 8 | 368 |
| Requests for Special Protocol Assessment | 151 | 2.48 | 374 | 15 | 5,610 |
| Total | | | | | 5,978 |
Dated: June 15, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.