E7-4450. Agency Information Collection Activities; Proposed Collection; 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 an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements establishing restrictions on the import, capture, transport, sale, barter, exchange, distribution, and release of African rodents, prairie dogs, and certain other animals.

DATES:

Submit written or electronic comments on the collection of information by May 14, 2007.

ADDRESSES:

Submit electronic comments on the collection of information to: http://www.fda.gov/​dockets/​ecomments. Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the 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:

Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Control of Communicable Diseases; African Rodents and Other Animals That May Carry the Monkeypox Virus—21 CFR 1240.63 (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 x 4 hours per response = 488 hours).

FDA estimates the burden of this collection of information as follows:

Estimated Annual Reporting Burden¹

21 CFR Section	No. of Respondents	Annual Frequency per Response	Total No. of 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: March 6, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.