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 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 75, No. 232 / Friday, December 3, 2010 / Notices 75483 

Drug Products; Questions and Answers.’’ 

This document answers questions 

regarding CVM’s implementation of 

USP <467> Residual Solvents. 

II. Significance of Guidance 

This level 1 draft guidance is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The draft guidance, when 

finalized, will represent the Agency’s 

current thinking on this topic. It does 

not create or confer any rights for or on 

any person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

III. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in this guidance have 

been approved under OMB control nos. 

0910–0032 and 0910–0669. 

IV. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

V. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

http://www.fda.gov/AnimalVeterinary/ 

GuidanceComplianceEnforcement/ 

GuidanceforIndustry/default.htm or 

http://www.regulations.gov. 

Dated: November 12, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–30387 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–2009–D–0533] 

Guidance for Industry: 

Recommendations for Blood 

Establishments: Training of Back-Up 

Personnel, Assessment of Blood 

Donor Suitability, and Reporting 

Certain Changes to an Approved 

Application; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a document entitled 

‘‘Guidance for Industry: 

Recommendations for Blood 

Establishments: Training of Back-Up 

Personnel, Assessment of Blood Donor 

Suitability and Reporting Certain 

Changes to an Approved Application’’ 

dated November 2010. The guidance 

document provides recommendations to 

blood establishments for training of 

back-up personnel, assessment of blood 

donor suitability, and how to report 

certain changes to an approved license 

application to FDA. The guidance 

announced in this document finalizes 

the draft guidance entitled ‘‘Draft 

Guidance for Industry: 

Recommendations for the Assessment of 

Blood Donor Suitability, Blood Product 

Safety, and Preservation of the Blood 

Supply in Response to Pandemic 

(H1N1) 2009 Virus’’ dated November 

2009. The guidance announced in this 

document also is superseding certain 

recommendations in two previous 

guidances, the guidance document 

entitled ‘‘Guidance for Industry: 

Changes to an Approved Application: 

Biological Products: Human Blood and 

Blood Components Intended for 

Transfusion or for Further Manufacture’’ 

dated July 2001 and the guidance 

document entitled ‘‘Guidance for 

Industry: Streamlining the Donor 

Interview Process: Recommendations 

for Self-Administered Questionnaires’’ 

dated July 2003. 

DATES: Submit either electronic or 

written comments on agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Office of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 1401 

Rockville Pike, Suite 200N, Rockville, 

MD 20852–1448. Send one selfaddressed adhesive label to assist the 

office in processing your requests. The 

guidance may also be obtained by mail 

by calling CBER at 1–800–835–4709 or 

301–827–1800. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

Submit electronic comments on the 

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: 

Benjamin A. Chacko, Center for 

Biologics Evaluation and Research 

(HFM–17), Food and Drug 

Administration, 1401 Rockville Pike, 

Suite 200N, Rockville, MD 20852–1448, 

301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a document entitled ‘‘Guidance for 

Industry: Recommendations for Blood 

Establishments: Training of Back-Up 

Personnel, Assessment of Blood Donor 

Suitability and Reporting Certain 

Changes to an Approved Application’’ 

dated November 2010. The guidance 

document provides recommendations to 

blood establishments for training of 

back-up personnel, assessment of blood 

donor suitability, and reporting certain 

changes to an approved license 

application to FDA. 

In the Federal Register of November 

19, 2009 (74 FR 59982), FDA announced 

the availability of the draft guidance 

entitled ‘‘Draft Guidance for Industry: 

Recommendations for the Assessment of 

Blood Donor Suitability, Blood Product 

Safety, and Preservation of the Blood 

Supply in Response to Pandemic 

(H1N1) 2009 Virus’’ (November 2009). 

At that time, we anticipated that the 

rapid spread of pandemic (H1N1) 2009 

virus had the potential to cause 

disruptions in the blood supply and that 

the usual practices for ensuring blood 

availability in response to local disasters 

(i.e., hurricanes) would not be 

applicable or sufficient under a severe 

pandemic scenario. Since we issued the 

draft guidance, the H1N1 influenza 

pandemic has waned in the United 

States and disruptions in the blood 

supply have not been observed. 

Therefore, we are not finalizing those 

recommendations set forth in the draft 

guidance that referred to blood donor 

deferral and blood product management 

specific to the pandemic (H1N1) 2009 

virus. Instead, we are finalizing those 

recommendations contained in the draft 

guidance that are of general 

mstockstill on DSKH9S0YB1PROD with NOTICES