7272 Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

Section of the Federal 

Food, Drug, 

and Cosmetic Act 

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Respondents 

Hours per 

Response Total Hours 

520(m)(6)(A)(iii) 1 1 1 100 100 

520(m)(6)(C) 5 1 5 100 500 

Total 1,250 

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

FDA based these estimates on the 

number of original HDE applications 

that the Center for Devices and 

Radiological Health (CDRH) received for 

the period October 1, 2004, through 

September 30, 2007. During that time, 

CDRH received 16 original HDE 

applications or about 5 per year. 

FDA estimates that for each year, 

CDRH will receive five HDE 

applications and that three of these 

applications will be indicated for 

pediatric use. One HDE holder will 

notify the agency that the number of 

devices distributed in the year has 

exceeded the ADN and five HDE holders 

will petition to have the ADN modified 

due to additional information on the 

number of individuals affected by the 

disease of condition. 

The draft guidance refers also to 

previously approved collections of 

information found in FDA regulations. 

The collections of information in 21 

CFR part 803 have been approved under 

OMB control number 0910–0437; the 

collections of information in 21 CFR 

part 812 have been approved under 

OMB control number 0910–0078; the 

collections of information in 21 CFR 

part 807, subpart E, have been approved 

under OMB control number 0910–0120; 

the collections of information in 21 CFR 

part 814, subparts A, B, and C, have 

been approved under OMB control 

number 0910–0231; the collection of 

information in 21 CFR parts 50 and 56 

have been approved under OMB control 

number 0910–0130; the collections of 

information in 21 CFR part 820 have 

been approved under OMB control 

number 0910–0073; the collections of 

information in 21 CFR part 814, subpart 

H, have been approved under OMB 

control number 0910–0332; and the 

collection of information requirements 

in 21 CFR 10.30 have been approved 

under OMB control number 0910–0183. 

Dated: February 4, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–3030 Filed 2–17–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0512] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

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 

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 March 22, 

2010. 

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 e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910—NEW and 

title ‘‘Antimicrobial Animal Drug 

Distribution Reports Under Section 105 

of the Animal Drug User Fee 

Amendments of 2008.’’ 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, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 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. 

Antimicrobial Animal Drug 

Distribution Reports Under Section 105 

of the Animal Drug User Fee 

Amendments of 2008—(OMB Control 

Number 0910–NEW)—Extension 

Section 105 of the Animal Drug User 

Fee Amendments of 2008 (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 § 514.80(b)(4) (21 CFR 

§ 514.80(b)(4) (OMB Control No. 0910– 

0284). 

In the Federal Register of October 26, 

2009 (74FR 55046), FDA published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. FDA received comments 

from two organizations. Both 

commenters supported the information 

collection and stated that the data to be 

collected would be useful in addressing 

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Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices 7273 

the problem of antimicrobial resistance. 

However, both comments suggested that 

more extensive measures are necessary 

to address this problem. For example, 

one of the comments stated that the 

practical utility of the data would be 

broadened in conjunction with a larger 

federal monitoring effort requiring 

manufacturers to report uses of their 

products in all food animal products, 

which would involve collecting data 

from end users such as veterinarians 

and animal owners. The other comment 

stated that the information collection 

would not be sufficient to show how 

much of each class of antimicrobial is 

sold for use in different types of food 

animals, and recommended that FDA 

collect distribution data on medicated 

feeds for this purpose because feeds are 

specific to animal species and class. The 

comment also recommended that FDA 

require all data to be submitted through 

a Web-based application directly into a 

form created by FDA, and that FDA 

create a publically accessible database 

that allows searches by drug class, dose 

form, and marketing status. FDA has 

considered the comments, but at this 

time we have decided to only require 

the submission of information that is 

expressly required to be submitted by 

section 512(l)(3) of the act. We are 

pursuing notice and comment 

rulemaking to codify these 

requirements, during which time we 

will assess any additional data 

requirements. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

FD&C Act 

Section 512(l)(3) 

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response 

Total 

Hours 

Capital 

Cost 

Annual Reports for 

Sponsors with Active Applications 29 6.7 194 80 15,520 $107,880 

Annual Reports for 

Sponsors with Inactive Applications 23 4.0 92 1 92 

Total 15,612 $107,880 

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

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

FD&C Act 

Section 512(l)(3) 

No. of 

Respondents 

Annual Frequency of 

Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

All Applicants 34 1 34 2 68 

Total 68 

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

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 foodproducing 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 Web site, 

however, use of the form would be 

entirely voluntary. The form contains 

various fields for information, including 

the drug manufacturer’s name, NADA 

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 either the FDA-provided 

form or one of their own design 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 x 80 hours x $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 

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7274 Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices 

1BLS Occupation Employment and Wages, May 

2006, by occupation, for all industries (http:// 

www.bls.gov). Wage ($46.50) includes mean hourly 

wage of $33.22 for Standard Occupational 

Classification 15–0000, computer and mathematics 

occupations, all industries; we add 40 percent to 

account for benefits. 

the statutory requirements of section 

512(l)(3) of the act.1 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) (OMB Control No. 

0910–0284). 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 an 

additional hourly burden required by 

section 512(l)(3) of the act as shown in 

table 2 of this document. 

Dated: February 4, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–3029 Filed 2–17–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2004–N–0390] (formerly 

Docket No. 2004N–0503) 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance on 

Consultation Procedures: Foods 

Derived From New Plant Varieties 

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 to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the information collection provisions of 

FDA’s consultation procedures for foods 

derived from new plant varieties, 

including the information collection 

provisions in the guidance entitled 

‘‘Consultation Procedures: Foods 

Derived From New Plant Varieties,’’ and 

in Form FDA 3665 entitled ‘‘Final 

Consultation For Food Derived From a 

New Plant Variety (Biotechnology Final 

Consultation),’’ which developers may 

use to prepare the final consultation in 

a standard format. 

DATES: Submit written or electronic 

comments on the collection of 

information by April 19, 2010. 

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, 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. In the Federal 

Register of November 24, 2004 (69 FR 

68379), FDA published a previous 60- 

day notice requesting public comment 

on this proposed collection of 

information. FDA is publishing this 

notice to update comments. Comments 

previously submitted to the Division of 

Dockets Management do not need to be 

resubmitted because all such comments 

that are responsive to the comment 

request will be summarized and 

responded to in the Information 

Collection Request, i.e. 30-day notice, 

submitted to OMB. 

Guidance on Consultation Procedures: 

Foods Derived From New Plant 

Varieties 

Since 1992, when FDA issued its 

Statement of Policy: Foods Derived from 

New Plant Varieties (the 1992 policy) 

(57 FR 22984, May 29, 1992), FDA has 

encouraged developers of new plant 

varieties, including those varieties that 

are developed through biotechnology, to 

consult with FDA during the plant 

development process to discuss possible 

scientific and regulatory issues that 

might arise. In the 1992 policy, FDA 

explained that, under the Federal Food, 

Drug, and Cosmetic Act (the act), 

developers of new foods (in this 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES