2302 Federal Register / Vol. 77, No. 10 / Tuesday, January 17, 2012 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0032] 

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, 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 

paperwork requirements for an 

electronic form (e-form), to collect 

distribution reports for antimicrobials in 

food producing animals. 

DATES: Submit either electronic or 

written comments on the collection of 

information by March 19, 2012. 

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 II, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, (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(l)(3) (OMB Control Number 0910– 

0659)—Revision 

Section 105 of the Animal Drug User 

Fee Amendments of 2008 (ADUFA II) 

(Public Law 316) amended section 512 

of the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) (21 U.S.C. 360b) by, 

among other things, creating section 

512(l)(3) 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 under the statute was to be 

submitted not later than March 31, 

2010. The report covered the period of 

the preceding calendar year and 

included separate information for each 

month of the calendar year. 

We are now seeking to further 

implement the statutory requirements of 

ADUFA II and enhance its public health 

and safety mission as envisioned by 

Congress by introducing an electronic 

form for the submission of the required 

annual reports under ADUFA II. The eform FDA 3744a will enable sponsors to 

submit electronically and capture all 

information as mandated by Section 105 

of ADUFA II. Form FDA 3744 will 

continue to be designated for paper 

submissions. 

List of information required on form 

FDA 3744 and e-form FDA 3744a: 

• Application Type 

• Application Number 

• Firm Name 

• Dosage Form(s) 

• Production Class(es) 

• Animal Species—Food Animal or 

Food and Non-Food Animal 

• Indications 

• Active Ingredient(s) 

• Domestic Quantities 

Æ Unit of Measure for All Active 

Ingredients 

Æ Calendar Year 

Æ Quantity Sold by Month for All 

Active Ingredients 

Æ Annual Total Sold for All Active 

Ingredients 

• Export Quantities 

Æ Unit of Measure for All Active 

Ingredients 

Æ Calendar Year 

Æ Quantity Sold by Month for All 

Active Ingredients 

Æ Annual Total Sold for All Active 

Ingredients 

• Individual Product Information for 

All Active Ingredients 

Æ Dosage Form 

Æ Container Size 

Æ Container Units 

Æ Active Ingredient Strength 

• Quantities of Individual Products 

Sold or Distributed (Domestic and 

Export) 

Æ Unit of Measure for All Active 

Ingredients 

Æ Quantity Sold by Month for All 

Active Ingredients 

Æ Annual Total Sold for All Active 

Ingredients 

FDA estimates the burden of this 

collection of information as follows: 


srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 10 / Tuesday, January 17, 2012 / Notices 2303 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

FD&C Act section 

512(l)(3) Form FDA No. Number of respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours Capital costs 

Annual Reports for 

Sponsors With Active Applications— 

Paper Submission.

3744 ................. 14 5.9 83 60 4,980 $6,975 

Annual Reports for 

Sponsors With Active Applications— 

Electronic Submission.

e-Form 3744a ... 12 6.7 80 50 4,000 ........................

Annual Reports for 

Sponsors With Inactive Applications—Paper Submission.

3744 ................. 13 6.2 81 2 162 ........................

Annual Reports for 

Sponsors With Inactive Applications—Electronic 

Submission.

e-Form 3744a ... 11 7.3 80 2 160 ........................

Total ................... ........................... ........................ ........................ ........................ ........................ 9,302 ........................

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

The total annual responses were 

calculated by multiplying the number of 

respondents times the number of 

responses per respondent. Total burden 

hours were calculated by multiplying 

total annual responses times the average 

burden per response. 

As explained in the supporting 

statement for the subject collection of 

information (OMB control number 

0910–0659), the initial one-time capital 

costs are for the design of the report. 

Here, e-form FDA 3744a and reporting 

via the Electronic Submission Gateway 

are provided by FDA. Thus, the 

remaining cost, as described in 

approved OMB control number 0910– 

0659 is $6,975 per year (3 hours × 

$46.50 wage rate × 50 sponsors) = 

$6,975. FDA believes that the sponsors 

already possess the computer 

equipment needed to prepare the report 

so that additional capital expenditures 

will not be necessary. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Revised 21 CFR 514.80(b)(5) Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

All Applicants ....................................................................... 34 1 34 2 68 

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

Total annual records were calculated 

by multiplying the number of 

recordkeepers times the number of 

records per recordkeeper. Total hours 

were calculated by multiplying total 

annual records times the average burden 

per recordkeeping. 

Dated: January 10, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–639 Filed 1–13–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Member 

Conflict: Diabetes and Obesity. 

Date: January 26, 2012. 

Time: 9:30 a.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Virtual Meeting). 

Contact Person: Krish Krishnan, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6164, 

MSC 7892, Bethesda, MD 20892, (301) 435– 

1041, krishnak@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Member 

Conflict: Integrative Neuroscience. 

Date: February 2, 2012. 


srobinson on DSK4SPTVN1PROD with NOTICES