Agency Information Collection Activities; Proposals, Submissions, and Approvals:

 
CONTENT

Federal Register Volume 76, Number 211 (Tuesday, November 1, 2011)

Notices

Pages 67460-67461

From the Federal Register Online via the Government Printing Office [www.gpo.gov]

FR Doc No: 2011-28240

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Docket No. FDA-2011-N-0554

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Veterinary Feed

Directive

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

December 1, 2011.

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) 395-7285, or emailed to oira_submission@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: Juanmanuel Vilela, Office of

Information Management, Food and Drug Administration, 1350 Piccard Dr.,

PI50-400B, Rockville, MD 20850, (301) 796-7651, juanmanuel.vilela@fda.hhs.gov.

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 the passage of the Animal Drug Availability Act of 1996 (ADAA)

(Pub. L. 104-250), the Congress enacted legislation establishing a new class of restricted feed use drugs, veterinary feed directive (VFD) drugs, which may be distributed without involving State pharmacy laws.

Although controls on the distribution and use of VFD drugs are similar to those for prescription drugs regulated under section 503(f) of the

Federal Food, Drug and Cosmetic Act (21 U.S.C. 353(f)), the implementing VFD regulation (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 records must be maintained of the distribution of all medicated feeds containing VFD drugs. The VFD regulation ensures the protection of public health while enabling animal producers to obtain and use needed drugs as efficiently and cost-effectively as possible.

In the Federal Register of August 3, 2011(76 FR 46818), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received no comments that pertained to the information collection burden estimates.

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

Table 1--Estimated Annual Reporting Burden \1\

Number of 21 CFR section

Number of

responses per Total annual

Average burden

Total hours respondents

respondent

responses

per response

558.6(a)(3) through (a)(5)...

15,000

25

375,000

.25

93,750 558.6(d)(1)(i) through

300

1

300

.25

75

(d)(1)(iii)................. 558.6(d)(1)(iv)..............

20

1

20

.25

5 558.6(d)(2)..................

1,000

5

5,000

.25

1,250 514.1(b)(9)..................

1

1

1

3

3

Page 67461

Total.................... .............. .............. .............. .................

95,083

\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 2--Estimated Annual Recordkeeping Burden \1\

Number of 21 CFR section

Number of

records per

Total annual

Average burden per

Total hours

Recordkeepers recordkeeper

records

recordkeeping

558.6(c)(1) through (c)(4).........................................

112,500

10

1,125,000

.0167

18,788 558.6(e)(1) through (e)(4).........................................

5,000

75

375,000

.0167

6,263

Total.......................................................... .............. .............. .............. ...................

25,051

\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

The estimate of the times required for record preparation and maintenance is based on Agency communication with industry and Agency records and experience.

Dated: October 27, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.

FR Doc. 2011-28240 Filed 10-31-11; 8:45 am

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