E7-15939. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals

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 September 14, 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: [phone], or e-mailed to [e-mail]. All comments should be identified with the OMB control number 0910-0519. Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.

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.

Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals (OMB Control Number 0910-0519)—Extension

Under 21 CFR 1240.63(a)(2)(ii), an individual must submit a written request to seek permission to capture, offer to capture, transport, offer to transport, sell, barter, or exchange, offer to sell, barter, or exchange, distribute, offer to distribute, and/or release into the environment any of the following animals:

• Prairie dogs (Cynomys sp.),
• African Tree squirrels (Heliosciurus sp.),
• Rope squirrels (Funisciurus sp.)
• African Dormice (Graphiurus sp.),
• Gambian giant pouched rats (Cricetomys sp.),
• Brush-tailed porcupines (Atherurus sp.),
• Striped mice (Hybomys sp.), or

Any other animal so prohibited by order of the Commissioner of Food and Drugs (the Commissioner) because of that animal's potential to transmit the monkeypox virus.

The request cannot seek written permission to sell, barter, or exchange, or offer to sell, barter, or exchange, as a pet, the animals listed previously or any animal covered by an order by the Commissioner.

The request must state the reasons why an exemption is needed, describe the animals involved, and explain why an exemption will not result in the spread of monkeypox within the United States.

Our estimates are based on our current experience with the interim final rule. To estimate the number of respondents, we examined the number of requests we have received in fiscal year 2006. There were 122 requests, submitted by 65 individuals, in that time, and this figure represents a minor increase over the previous estimate of 120 annual responses (See 69 FR 7752, February 19, 2004). As we cannot determine whether the latest data indicates a trend towards more requests or is an anomaly, we have elected to increase our estimate to 122 requests. We also have revised the estimated number of respondents to 65 (compared to 120 in our previous estimate) and, as a result, adjusted the annual frequency per response to 1.88 (which represents 122 responses/65 respondents; the actual result is 1.8769, which we have rounded up to 1.88).

Furthermore, consistent with our earlier Paperwork Reduction Act submission, we will estimate that each respondent will need 4 hours to complete its request for an exemption. Therefore, the total reporting burden under 21 CFR 1240.63(a)(2)(ii)(A) and (B) will be 488 hours (122 responses × 4 hours per response = 488 hours).

In the Federal Register of March 13, 2007 (72 FR 11368), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received.

Table 1.—Estimated Annual Reporting Burden¹

21 CFR Section	No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Response	Total Hours
1240.63(a)(2)(ii)(A) and (B)	65	1.88	122	4	488
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: August 8, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.