Agency Information Collection Activities; Proposed Collection; Comment Request; Antimicrobial Animal Drug Distribution Reports Under Section 105 of the Animal Drug User Fee Amendments of 2008

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 and including each proposed extension of a collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on reporting and recordkeeping requirements for antimicrobial animal drug distribution as required by Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA).

DATES:

Submit written or electronic comments on the collection of information by December 28, 2009.

ADDRESSES:

Submit electronic comments on the collection of information to http://www.regulations.gov . 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:

Denver Presley, Jr., Office of Information Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-796-3793.

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 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.

Antimicrobial Animal Drug Distribution Reports Under Section 105 of the Animal Drug User Fee Amendments of 2008—Federal Food, Drug, and Cosmetic Act, Section 512(1)(3) (OMB Control Number 0910-NEW)

Section 105 of ADUFA amended section 512 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b) to require that the sponsor of each new animal drug that contains an antimicrobial agent submit an annual report to FDA on the amount of each antimicrobial active ingredient in the drug that is sold or distributed for use in food-producing animals, including information on any distributor-labeled product. The legislation was enacted to address the problem of antimicrobial resistance and to help ensure that FDA has the necessary information to examine safety concerns related to the use of antibiotics in food-producing animals (154 Congressional Record H7534).

Each report must specify: (1) The amount of each antimicrobial active ingredient by container size, strength, and dosage form, (2) quantities distributed domestically and quantities exported and (3) a listing of the target animals, indications, and production classes that are specified on the approved label of the product.

The first report must be submitted not later than March 31, 2010. The report must cover the period of the preceding calendar year and include separate information for each month of the calendar year. The reports required under section 105 of ADUFA are required to be separate from periodic drug experience reports that are required under 21 CFR 514.80(b)(4) (OMB Control No. 0910-0284).

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

The reporting burden estimates, including the total number of annual responses, are based on the number of sponsors and approved applications for antimicrobial drug products in food-producing animals. The annual frequency of responses was calculated as the total annual responses divided by the number of respondents.

The agency arrived at the estimates for reporting as follows: There are 34 sponsors with approved applications for antimicrobial drugs for food-producing animals. There are 29 animal drug manufacturers with 194 approved applications for antimicrobial drugs for food-producing animals for which the drugs are being actively marketed (active applications). Additionally, there are 93 approved applications for antimicrobial drugs for food-producing animals for which the drugs are not being marketed (inactive applications), owned by 23 animal drug manufacturers.

Regarding the reporting burden associated with the collection of information, FDA believes that the large majority of the burden will be incurred by industry in the first year in which reporting is required to design a report that meets the requirements of section 512(l)(3) of the act. The agency has estimated this burden at 80 hours per applicant with active applications. The agency has factored into this estimate the time it will take industry to identify and locate the necessary information within existing records, and to develop a report that complies with section 512(l)(3) of the act. Once this has been accomplished, FDA believes that the process for producing reports in subsequent years will essentially be automated, and that it will take approximately 3 hours to run a report that satisfies the act's requirements. For sponsors of approved applications that are inactive (i.e., the approved drug is not being marketed), the sponsor would only have to submit a report stating that the drug is not being marketed, which FDA estimates will take approximately 1 hour.

FDA has developed a form to report the information required by section 512(l)(3) of the act. FDA plans to make the form available to animal drug manufacturers through FDA's website however, use of the form would be entirely voluntary. The form contains various fields for information, including the drug manufacturer's name, new animal drug approval number, active ingredient name, National Drug Code number, container size, potency, and the number of units sold by month.

The animal drug manufacturers can meet the statutory requirements by submitting their information in paper format using the FDA-provided form, one of their own designs, or by designing their own electronic form whose results could be submitted to the agency on a compact disc or on paper. The cost to animal drug sponsors for gathering the necessary information for report design and preparation or for completing FDA's form in the first year of reporting is $107,880 (29 active sponsors times 80 hours times $46.50 per hour = $107,880). This is a one-time cost for a computer or mathematic employees to design and prepare a report that satisfies the statutory requirements of section 512(l)(3) of the act. For subsequent years, the preparation of the report should take approximately 3 hours. Thus, the total cost in subsequent years would be $139.50.

Regarding the recordkeeping burden associated with this collection of information, FDA believes that most of the necessary information for the annual report required to be submitted under section 512(l)(3) of the act is already collected and maintained by animal drug manufacturers under existing requirements.

Animal drug manufacturers are already required to maintain distribution records for their drug products to comply with FDA's current good manufacturing practice regulations under § 211.196 (21 CFR § 211.96) (OMB Control No. 0910-0139), and to comply with regulations for periodic drug experience reports under § 514.80(b)(4)(i) (21 CFR § 514.80(b)(4)(i)) (OMB Control No. 0910-0284) of FDA regulations. Therefore, FDA believes that manufacturers of animal drugs already possess the computers, software, and additional equipment necessary to collect and maintain the necessary records, and to make reports.

Section 512(l)(3) of the act differs from § 514.80(b)(4)(i) in that it requires that records include separate information for each month of the calendar year. Under § 211.196 (OMB Control No. 0910-0139), manufacturers currently are required to maintain distribution records that include the dosage form and date the drug is distributed. Additionally, FDA believes that manufacturers already keep detailed records of the dates when antimicrobial drugs are distributed for marketing and recall purposes from which monthly reports can be prepared as part of their usual and customary practice. However, FDA estimates additional hourly burden required by section 512(l)(3) of the Act as shown in table 2 of this document.