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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2005-N-0474] (formerly Docket No. 2005N-0210)
 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 October 6, 2008.
 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, or e-mailed to 
                        *baguilar@omb.eop.gov*. All comments should be identified with the OMB control number 0910-0363. Also include the FDA docket number found in brackets in the heading of this document.
 FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of Information Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-796-3793.


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. Veterinary Feed Directive—21 CFR Part 558 (OMB Control Number 0910-0363)—Extension With passage of the Animal Drug Availability Act, Congress enacted legislation establishing a new class of restricted feed use drugs called Veterinary Feed Directive (VFD) drugs. The VFD class of drugs may be distributed without involving State pharmacy laws. Although controls on the distribution and use of VFD drugs are similar to controls for prescription drugs regulated under section 503(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 503(f)), the implementing VFD regulation under section 558.6 (21 CFR 558.6) is tailored to the unique circumstances relating to the distribution of medicated feeds. The content of the VFD is spelled out in the regulation. All distributors of medicated feed containing VFD drugs must notify FDA of their intent to distribute, and the distribution records of all medicated feeds containing VFD must be maintained. The VFD regulation ensures the protection of the public health while enabling animal producers to obtain and use needed drugs as efficiently and cost-effectively as possible. In the 
                    **Federal Register**
                     of June 5, 2008 (73 FR 32029), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. FDA estimates the burden for this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden**1
21 CFR Section
No. of
                             Respondents
Annual Frequency
                             per Response
Total Annual
                             Responses
Hours per
                             Response
Total Hours558.6(a)(3) through (a)(5)
15,000
25
375,000
.25
93,750558.6(d)(1)(i) through (d)(1)(iii)
300
1
300
.25
75558.6(d)(1)(iv)
20
1
20
.25
5558.6(d)(2)
1,000
5
5,000
.25
1,250514..1(b)(9)
1
1
1
3.00
3Total
16,321



95,0831
                         There are no capital costs or operating and maintenance costs associated with this collection of information.
 **Table 2.—Estimated Annual Recordkeeping Burden**1
21 CFR Section
No. of
                             Recordkeepers
Annual Frequency
                             per Recordkeeping
Total Annual
                             Records
Hours per
                             Record
Total Hours558.6(c)(1) through (c)(4)
112,500
10
1,125,000
.0167
18,788558.6(e)(1) through (e)(4)
5,000
75
375,000
.0167
6,263Total
117,500



25,0511
                         There are no capital costs or operating and maintenance costs associated with this collection of information.
 Dated: August 28, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning.


[FR Doc. E8-20579 Filed 9-4-08; 8:45 am] BILLING CODE 4160-01-S