Federal Register / Vol. 75, No. 232 / Friday, December 3, 2010 / Notices 75481 

TABLE 1—TOTAL ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section Number of 

respondents 

Annual 

frequency 

per response 

Total annual 

responses 

Hours per 

response Total hours 

Physician survey—pretest ................................................... 100 1 100 .33 33 

Physician survey—main study ............................................. 600 1 600 .33 198 

Consumer experiment—pretest ........................................... 200 1 200 .25 50 

Consumer experiment—main study .................................... 2,500 1 2,500 .25 625 

Total .............................................................................. 906 

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

Dated: November 30, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–30385 Filed 12–2–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0597] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Index of Legally 

Marketed Unapproved New Animal 

Drugs for Minor Species 

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 

the burden hours associated with 

indexing of legally marketed 

unapproved new animal drugs for minor 

species. 

DATES: Submit either electronic or 

written comments on the collection of 

information by February 1, 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 

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. 

Index of Legally Marketed Unapproved 

New Animal Drugs for Minor Species— 

21 CFR Part 516 (OMB Control Number 

0910–0620)—Extension 

The Minor Use and Minor Species 

Animal Health Act of 2004 (MUMS Act) 

amended the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) to 

authorize FDA to establish new 

regulatory procedures intended to make 

more medications legally available to 

veterinarians and animal owners for the 

treatment of minor animal species 

(species other than cattle, horses, swine, 

chickens, turkeys, dogs, and cats), as 

well as uncommon diseases in major 

animal species. 

The MUMS Act added three new 

sections to the FD&C Act (sections 571, 

572, and 573 (21 U.S.C. 360ccc, 360ccc– 

1, and 360ccc–2, respectively)). The 

final rule (72 FR 69108, December 6, 

2007) implements section 572 of the 

FD&C Act, which provides for an index 

of legally marketed unapproved new 

animal drugs for minor species. 

Participation in any part of the MUMS 

program is optional so the associated 

paperwork only applies to those who 

choose to participate. The final rule 

specifies, among other things, the 

criteria and procedures for requesting 

eligibility for indexing and for 

requesting addition to the index as well 

as the annual reporting requirements for 

index holders. 

Under the new subpart C of part 516 

(21 CFR part 516, subpart C), § 516.119 

provides requirements for naming a 

permanent-resident U.S. agent by 

foreign drug companies, and § 516.121 

provides for informational meetings 

with FDA. Section 516.123 provides 

requirements for requesting informal 

conferences regarding agency 

administrative actions and § 516.125 

provides for investigational use of new 

animal drugs intended for indexing. 

Provisions for requesting a 

determination of eligibility for indexing 

can be found under § 516.129 and 

provisions for subsequent requests for 

addition to the index can be found 

under § 516.145. A description of the 

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75482 Federal Register / Vol. 75, No. 232 / Friday, December 3, 2010 / Notices 

written report required in § 516.145 can 

be found under § 516.143. Under 

§ 516.141 are provisions for drug 

companies to nominate a qualified 

expert panel as well as the panel’s 

recordkeeping requirements. This 

section also calls for the submission of 

a written conflict of interest statement to 

FDA by each proposed panel member. 

Index holders are able to modify their 

index listing under § 516.161 or change 

drug ownership under § 516.163. 

Requirements for records and reports 

are under § 516.165. 

Description of Respondents: 

Pharmaceutical companies that sponsor 

new animal drugs. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section Number of 

respondents 

Annual 

frequency 

per response 

Total annual 

responses 

Hours per 

response Total hours 

516.119 ................................................................................ 2 1 2 1 2 

516.121 ................................................................................ 30 2 60 4 240 

516.123 ................................................................................ 3 1 3 8 24 

516.125 ................................................................................ 2 3 6 20 120 

516.129 ................................................................................ 30 2 60 20 1,200 

516.141 ................................................................................ 20 1 20 16 320 

516.143 ................................................................................ 20 1 20 120 2,400 

516.145 ................................................................................ 20 1 20 20 400 

516.161 ................................................................................ 1 1 1 4 4 

516.163 ................................................................................ 1 1 1 2 2 

516.165 ................................................................................ 10 2 20 8 160 

Total .............................................................................. ........................ ........................ ........................ ........................ 4,872 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR Section Number of 

recordkeepers 

Annual 

frequency per 

recordkeeper 

Total annual 

records 

Hours per 

recordkeeper Total hours 

516.141 ................................................................................ 30 2 60 0.5 30 

516.165 ................................................................................ 10 2 20 1 20 

Total .............................................................................. ........................ ........................ ........................ ........................ 50 

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

Dated: November 29, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–30335 Filed 12–2–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0566] 

Draft Guidance for Industry on 

Residual Solvents in Animal Drug 

Products; Questions and Answers; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry #211 entitled ‘‘Residual 

Solvents in Animal Drug Products; 

Questions and Answers.’’ The draft 

questions and answers (Q&A) guidance 

addresses the United States 

Pharmacopeia (USP) General Chapter 

<467> Residual Solvents that applies to 

both human and veterinary drugs and to 

compendial and non-compendial drug 

products. This document answers 

questions regarding CVM’s 

implementation of USP <467> Residual 

Solvents. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance by February 1, 2011. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Communications Staff (HFV–12), Center 

for Veterinary Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

Submit electronic comments on the 

draft guidance 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: 

Sudesh Kamath, Center for Veterinary 

Medicine (HFV–145), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8260, email: sudesh.kamath@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On July 1, 2008, the USP 

implemented a requirement for the 

control of residual solvents in drug 

products marketed in the United States. 

Once implemented, the requirement, 

USP General Chapter <467> Residual 

Solvents, became a statutory 

requirement under section 501(b) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 351(b)). 

FDA is announcing the availability of 

a draft guidance for industry #211 

entitled ‘‘Residual Solvents in Animal 

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