Federal Register / Vol. 75, No. 228 / Monday, November 29, 2010 / Notices 73103 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN (REGISTERED LICENSED MIXER-FEEDERS) 1

21 CFR Section No. of recordkeepers 

Annual frequency per 

recordkeeping 

Total annual 

records 

Hours per 

record Total hours 

225.42(b)(5) through (b)(8) ................................................ 100 260 26,000 .15 3,900 

225.58(c) and (d) ............................................................... 100 36 3,600 .5 1,800 

225.80(b)(2) ....................................................................... 100 48 4,800 .12 576 

225.102(b)(1) ..................................................................... 100 260 26,000 .4 10,400 

Total ............................................................................ ........................ ........................ ........................ .......................... 16,676 

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

TABLE 3—ESTIMATED ANNUAL RECORDKEEPING BURDEN (NONREGISTERED UNLICENSED COMMERCIAL FEED MILLS) 1

21 CFR Section No. of recordkeepers 

Annual frequency per 

recordkeeping 

Total annual 

records 

Hours per 

record Total hours 

225.142 .............................................................................. 8,000 4 32,000 1 32,000 

225.158 .............................................................................. 8,000 1 8,000 4 32,000 

225.180 .............................................................................. 8,000 96 768,000 .12 92,160 

225.202 .............................................................................. 8,000 260 2,080,000 .65 1,352,000 

Total ............................................................................ ........................ ........................ ........................ .......................... 1,508,160 

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

TABLE 4—ESTIMATED ANNUAL RECORDKEEPING BURDEN (NONREGISTERED UNLICENSED MIXER-FEEDERS) 1

21 CFR Section No. of recordkeepers 

Annual frequency per 

recordkeeping 

Total annual 

records 

Hours per 

record Total hours 

225.142 .............................................................................. 45,000 4 180,000 1 180,000 

225.158 .............................................................................. 45,000 1 45,000 4 180,000 

225.180 .............................................................................. 45,000 32 1,440,000 .12 172,800 

225.202 .............................................................................. 45,000 260 11,700,000 .33 3,861,000 

Total ............................................................................ ........................ ........................ ........................ .......................... 4,393,800 

1There 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 communications with 

industry. Other information needed to 

finally calculate the total burden hours 

(i.e., number of recordkeepers, number 

of medicated feeds being manufactured, 

etc.) is derived from Agency records and 

experience. 

Dated: November 23, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–29928 Filed 11–26–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0600] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Animal Drug User 

Fee Cover Sheet, Form 3546 

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 

burden hours necessary to complete 

FDA Form 3546, Animal Drug User Fee 

Act (ADUFA) Cover Sheet. 

DATES: Submit either electronic or 

written comments on the collection of 

information by January 28, 2011. 

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: 

Johnny 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: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

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73104 Federal Register / Vol. 75, No. 228 / Monday, November 29, 2010 / Notices 

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, 

including each proposed extension of an 

existing 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. 

Animal Drug User Fee Cover Sheet; 

FDA Form 3546 (OMB Control Number 

0910–0539)—Extension 

Under section 740 of the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) (21 U.S.C. 379j–12), as 

amended by ADUFA, FDA has the 

authority to assess and collect for 

certain animal drug user fees. Because 

the submission of user fees concurrently 

with applications and supplements is 

required, review of an application 

cannot begin until the fee is submitted. 

The types of fees that require a cover 

sheet are certain animal drug 

application fees and certain 

supplemental animal drug application 

fees. The cover sheet (FDA Form 3546) 

is designed to provide the minimum 

necessary information to determine 

whether a fee is required for the review 

of an application or supplement, to 

determine the amount of the fee 

required, and to assure that each animal 

drug user fee payment and each animal 

drug application for which payment is 

made is appropriately linked to the 

payment that is made. The form, when 

completed electronically, will result in 

the generation of a unique payment 

identification number used in tracking 

the payment. FDA will use the 

information collected to initiate 

administrative screening of new animal 

drug applications and supplements to 

determine if payment has been received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Section of the FD&C Act as amended by ADUFA Number of respondents 

Annual 

frequency per 

response 

Total annual 

responses 

Hours per 

response Total hours 

740(a)(1), FDA Form 3546 (Cover Sheet) .......................... 76 1 76 1 76 

Total .............................................................................. ........................ ........................ ........................ ........................ 76 

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

Respondents to this collection of 

information are new animal drug 

applicants or manufacturers. Based on 

FDA’s database system, there are an 

estimated 140 manufacturers of 

products or sponsors of new animal 

drugs potentially subject to ADUFA. 

However, not all manufacturers or 

sponsors will have any submissions in 

a given year and some may have 

multiple submissions. The total number 

of annual responses is based on the 

number of submissions received by FDA 

in fiscal year 2008. The estimated hours 

per response are based on past FDA 

experience with the various 

submissions. The hours per response are 

based on the average of these estimates. 

Dated: November 22, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–29820 Filed 11–26–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0547] 

Clinical Development Programs for 

Sedation Products; Request for 

Assistance 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is seeking 

information on a variety of issues 

related to the clinical development and 

use of sedation products in adult and 

pediatric age groups. FDA is inviting 

any interested party, or parties, to 

facilitate an evaluation of critical 

fundamentals of the science related to 

sedation products by conducting and 

managing a coordination of activities 

that will bring together experts in the 

field, including from academia, patient 

organizations, and industry. The first 

step in this process would be for the 

party or parties to plan and hold one or 

more public meetings to discuss these 

issues. FDA intends to take into account 

the information provided from these 

activities as we develop FDA guidance 

on clinical development programs for 

sedation products. We intend to submit 

to the docket all the information 

received in response to this notice so 

that interested parties may be fully 

informed. 

DATES: Submit electronic or written 

comments on this notice by January 28, 

2011. 

ADDRESSES: Submit electronic 

comments on this notice to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: Sara 

E. Stradley, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, rm. 3162, Silver Spring, 

MD 20993–0002, 301–796–1298, 

FAX:301–796–9713, e-mail: 

sara.stradley@fda.hhs.gov. 

mstockstill on DSKH9S0YB1PROD with NOTICES