0363 Veterinary Feed Directive SS for 2015 final rule

Veterinary Feed Directive
OMB Control No. 0910-0363
Supporting Statement

A. Justification
1. Circumstances Making the Collection of Information Necessary
In 1996, the Animal Drug Availability Act (ADAA) (Public Law 104–250) was enacted to
facilitate the approval and marketing of new animal drugs and medicated feeds. Among other
things, the ADAA created a new regulatory category for certain new animal drugs called
veterinary feed directive drugs (or VFD drugs). VFD drugs are new animal drugs intended for
use in or on animal feed which are limited to use under the professional supervision of a licensed
veterinarian in the course of the veterinarian’s professional practice. The VFD regulation was
tailored to the unique circumstances relating to the use of certain medicated feeds. All
distributors of medicated feed containing VFD drugs must notify FDA of their intent to distribute
such feed, and records must be maintained of the distribution and feeding (under the professional
supervision of a licensed veterinarian) of all medicated feeds containing VFD drugs. 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.
On December 12, 2013, FDA published a proposed rule in the Federal Register (78 FR 75515)
intended to improve the efficiency of FDA’s VFD program. The provisions included in the
proposed rule were based on stakeholder input received in response to solicitations for public
comment, including an advanced notice of proposed rulemaking on March 29, 2010 (75 FR
15387), and draft text of proposed amendments to the current VFD regulations on April 13, 2012
(77 FR 22247). FDA is now finalizing the rule and thereby revising the information collection
provisions by lowering the recordkeeping burden without compromising human or animal safety,
by providing greater deference and flexibility to the veterinary profession for licensing and
veterinary practice requirements, and by ensuring continued access to Category I Type A
medicated articles by unlicensed feed mills.
We are specifically requesting approval for the following provisions, noting that there has been
some renumbering of the codified regulations:
Reporting
21 CFR 558.6(c)(4); requires notification to the FDA by the distributor upon first engaging in
distribution of VFD feeds.
Reporting
21 CFR 558.6(c)(6); requires a change of address notification by a distributor when applicable.

Recordkeeping
21 CFR 558.6(c); requires maintenance of VFD records for two years after the date of issuance
by all parties (i.e., veterinarians, distributors, and producers).
Recordkeeping
21 CFR 558.6(e); requires the distributor to keep records of receipt and distribution of all
medicated animal feeds containing VFD drugs.
3rd Party Disclosure
21 CFR 558.6(b)(7); issuance of a VFD by veterinarian with specific information.
3rd Party Disclosure
21 CFR 558.6(c)(8); generation of acknowledgement letter.
This information collection is not related to the American Recovery and Reinvestment Act of
2009.
2. Purpose and Use of the Information
A VFD drug is limited to use under the professional supervision of a licensed veterinarian,
wherein the veterinarian assumes the responsibility for safe and effective use of a VFD drug and
the client has agreed to follow the instructions of the veterinarian. Control of certain
antimicrobials is critical to reducing unnecessary use of such drugs in animals and to slowing or
preventing the development of bacteria resistance to antimicrobial drugs. Safety concerns
relating to difficulty of diagnosis of disease conditions, high toxicity, or other reasons, may also
require that the use of an animal drug in animal feed be limited to use by order and under the
supervision of a licensed veterinarian. The implementing VFD regulations are tailored to the
unique circumstances relating to the distribution and use of animal feeds containing a VFD drug.
The information collected by FDA staff will help assure compliance with the VFD regulation
and provide assurance that the medicated feeds will be safe and effective for their labeled
conditions of use and that edible products from treated animals will be free of unsafe drug
residues.
Entities affected are from the private sector: veterinarians, distributors, and animal food
producers, who are private businesses, will be affected by this information collection.
3. Use of Information Technology and Burden Reduction
The industry is increasingly turning to the use of automated production facilities. The use of
information technology is acceptable for the purposes of recordkeeping for FDA inspections.
Currently about 50% (half) of submissions are electronic, however, we expect this number to
increase.

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4. Efforts to Identify Duplication and Use of Similar Information
Each veterinarian, client, and manufacturer/distributor of VFD feed is responsible for his/her
own recordkeeping. Further, there are no other regulations that would require the submission or
retention of this material. Therefore, duplication would not occur.

5. Impact on Small Business or Other Small Entities
The proposed collection of information carries the same burden, per VFD, for small or large
firms. The regulation should not have a significant effect on small business, as the cost of the
additional veterinary service and paperwork burden is minimal and constitutes an insignificant
percentage of revenue of the affected firms.
The agency estimates that 100% of respondents are private sector businesses.

6. Consequences of Collecting the Information Less Frequently
All reporting and recordkeeping are one-time events associated with the issuance of a VFD.

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
All of the reporting requirements are consistent with 5 CFR 1320.5.

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
A proposed rule revising the VFD regulations was published in the Federal Register on
December 12, 2013 (78 FR 75515). FDA received some feedback suggesting that the current
VFD process was overly burdensome. In response to this concern, FDA began exploring ways
to improve the VFD program’s efficiency including the ability of respondents to retain and
submit VFD forms electronically without the requirement to also send the original paper form.
Other comments to the rulemaking fell outside the scope of the PRA, but are addressed in the
agency’s preamble to the final rule.

9. Explanation of Any Payment or Gift to Respondent
There are no payments or gifts to respondents.

10. Assurance of Confidentiality Provided to Respondent
Information is kept confidential in accordance with 18 USC 1905 and 21 USC 3310.
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11. Justification for Sensitive Questions
This information collection does not contain questions pertaining to sexual behavior, attitude,
religious beliefs, or any other matter commonly considered private or of a sensitive nature.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
The table below presents what the agency believes is a one-time burden resulting from the final
rule. We believe that this burden reflects what the respective respondents may expend in order
to determine which actions are necessary to comply with the regulations. We believe the total
burden reflected in this table will be realized upon implementation of the final rule.
One-time Burden to Review Rule
Applicable Burden; Respondent
Reporting; VFD Feed Distributers
Recordkeeping; Food Animal
Veterinarian
Recordkeeping; Clients
(Producers)
3rd Party Disclosure; VFD Drug
Sponsors (General and Operations
Managers)
Total

Estimated No. of
Respondents
1,376
3,050

Estimated Time for
Review
4
1

Total One-time
Burden
5,504
3,050

10,000

0.5

5,000

3

6

18

14,429

13,572

The following tables are included in the Paperwork Analysis section of the final rule. The
analysis explains in detail how the revisions to the burden hours and costs were calculated.
Burden hours and costs were derived from the agency’s Final Regulatory Impact Analysis
(FRIA) supporting the final rule.
Table 1 – Estimated Annual Reporting Burden1
21 CFR Section; Activity

558.6(c)(4); a distributor must
notify FDA prior to the first
time it distributes a VFD
drug.
558.6(c)(6); a distributor must
notify FDA within 30 days of
any change in ownership,
business name, or business
address.
Total
1

No. of
Respondents

No. of Responses
per Respondent

Total Annual
Responses

Avg. Burden
per Response

Total
Hours

1

300

.125

37.5

1

20

.125

2.5

300

20

40

There are no operating and maintenance costs associated with this collection of information.

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Table 2 – Estimated Annual Recordkeeping Burden1
21 CFR Section;
Activity

No. of
Recordkeepers

No. of Records
Total Annual
Avg. Burden
Total
per
Records
per
Hours
Recordkeeper
Recordkeeping
13,050
114.9
1,500,000
.0167 25,050

558.6(c)(1) through
(c)(4); filing of
VFD copies by
veterinarians and
producers.
558.6(e)(1) through
(e)(4); filing of
VFD copies by
distributors only.
Total
1

1,376

545.1

750,000

14,426

.0167

2,250,000

12,525

37,575

There are no operating and maintenance costs associated with this collection of information.

Table 3.—Estimated Annual 3rd Party Disclosure1
21 CFR Section;
Activity

558.6(b)(7);veterinarian
issues VFD
558.6(c)(8);
acknowledgement letter
generation3
TOTAL

Total Annual
No. of
Disclosures
Disclosures
per
Respondent
3,050
246
750,000

No. of
Disclosures per
Respondent

1,000

5

5,000

Total
Avg.
Hours
Burden
per
Disclosure
0.125
93,750
0.125

625

94,375

1

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

12b. Annualized Cost Burden Estimate
Type of Respondent

VFD Feed Distributors
Clients (Producers)
Drug Sponsors
Veterinarian
TOTAL

Total Burden Hours

13,230
12,525
3
106,275
132,033

Hourly Wage Rate

$71.00
$31.00
$83.00
$84.00

Total Respondent
Costs

$939,330
$388,275
$249
$8,927,100
$10,254,954

13. Estimate of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
The following cost table is based on the agency’s FRIA for the final rule.

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Table 4 – Annualized Cost Burden Estimate
Type of Respondent

Total Burden Hours

Hourly Wage Rate

Total Respondent Cost

One-Time Cost Burden
VFD Feed Distributors –
Review of Final Rule
Veterinarians –Review of Final
Rule
Clients – Review of Final Rule
Sponsors – Review of Final
Rule
Total One-time Cost Burden

5,504

$96.00

$529,000

3,050

$84.00

$255,000

5,000

$49.00

$244,000

18

$140.00

$2,500

13,572

$1,030,500

Annual Cost Burden
VFD Feed Distributors
(Reporting)
VFD Feed Distributors
(Recordkeeping, Third-party
Disclosure)
Veterinarians (Recordkeeping,
Third-Party Disclosure)
Clients (Recordkeeping)

40

$96.00

$384

13,150

$77.00

$1,012,550

106,275

$84.00

$8,927,100

12,525

$49.00

$613,725

Total Annual Cost Burden

131,990

$10,553,759

TOTAL

145,562

$11,584,259

For Feed Distributors, FDA estimates review of the final rule and notifications to FDA to be
completed by personnel at the general and operations manager level. The NAICS code 311100-Animal Food Manufacturing, reports the hourly compensation (including the 100% increase for
total overhead costs) at about $96 per hour. FDA estimates other information collection tasks
(recordkeeping and issuance of acknowledgement letters) to be completed by personnel at the
industrial production manager level, at a total compensation rate (including all overhead costs) of
about $77 per hour.
FDA estimates that there are about 3,050 veterinarians that exclusively treat food-producing
animals. We use the AVMA 2010 median veterinarian hourly compensation rate of about $39,
and adjust it to include the additional 100% for total overhead costs, as well as adjust it to 2013
dollars. The result is an estimated compensation rate of about $84 per hour.
For sponsors of the VFD drugs that FDA has approved, FDA estimates information collection
tasks to be completed by personnel at the general and operations manager level. The hourly pay
for general and operations managers at firms in the North American Industrial Classification
System (NAICS) code 325400--Pharmaceutical and Medicine Manufacturing, is about $70.
When adjusted for total overhead costs at 100 percent, the resulting total compensation is about
$140 per hour.

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For animal food producers (clients), FDA uses the Bureau of Labor Statistics’ Occupation
Employment and Wage data that reports the median wage of a first-line supervisor of farming,
fishery, and forestry workers (adjusted for total overhead costs at 100% of labor costs)) of about
$49 per hour.
We estimate that the capital costs for recordkeeping as a result of the final rule will be reduced
from $180,000 (storing paper copies of all VFDs in file cabinets for 2 years) to $90,000 (one-half
of VFDs stored as paper copies in 150 file cabinets for 2 years), and an annual cost savings of
$19,600 for one-half of the industry filing VFDs electronically for 2 years.
14. Annualized Cost to the Federal Government
FDA estimates that the review and other administrative costs associated with a labeling
supplement submitted by a VFD drug sponsor would require 3 hours. Based on the Fiscal Year
2010 appropriation for the Center for Veterinary Medicine at FDA, the average annual cost of
one of these employees is $213,000, including the cost of all overhead support of that full time
employee. This equates to an hourly wage of about $102. We have adjusted this wage to about
$108 per hour in 2013 dollars. The total review and filing effort for FDA employees for the 6
VFD drug labeling supplements that are expected to be submitted would be 18 hours, with a total
cost of about $1,900.
15. Explanation of Program Changes and Adjustments
The estimated burden for this information collection has been revised to reflect the agency’s
finalization of its rulemaking for the VFD program, including the one-time burden imposed upon
implementation of the rule as well as the recurring burden associated with ongoing regulatory
compliance. This results in an immediate increase in the number of annual responses by 769,428
and an increase in burden hours of 13,530; however, the agency believes that, upon
implementation of the final rule and realization of the one-time burden, this final rule will result
in an overall decrease in annual burden.
Also, upon reexamining this collection, we removed the reporting burden found in 21 CFR
514.1(b)(9) (requiring submission of a VFD form by drug sponsors as a part of the new animal
drug application) because this is accounted for under OMB Control No. 0910-0032 (New Animal
Drug Applications).
16. Plans for tabulation and Publication and Project Time Schedule
Information is not to be published for statistical use.
17. Reason Display of OMB Expiration Date Is Inappropriate
There is no reason not to display the OMB expiration date.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.
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