Draft Guidance for Industry on Residual Solvents in Animal Drug Products; Questions and Answers; Availability, 75482-75483 [2010-30387]

Download as PDF 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 Number of respondents 21 CFR Section 516.119 516.121 516.123 516.125 516.129 516.141 516.143 516.145 516.161 516.163 516.165 Annual frequency per response Total annual responses Hours per response Total hours ................................................................................ ................................................................................ ................................................................................ ................................................................................ ................................................................................ ................................................................................ ................................................................................ ................................................................................ ................................................................................ ................................................................................ ................................................................................ 2 30 3 2 30 20 20 20 1 1 10 1 2 1 3 2 1 1 1 1 1 2 2 60 3 6 60 20 20 20 1 1 20 1 4 8 20 20 16 120 20 4 2 8 2 240 24 120 1,200 320 2,400 400 4 2 160 Total .............................................................................. ........................ ........................ ........................ ........................ 4,872 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers Annual frequency per recordkeeper 516.141 ................................................................................ 516.165 ................................................................................ 30 10 2 2 60 20 0.5 1 30 20 Total .............................................................................. ........................ ........................ ........................ ........................ 50 21 CFR Section 1 There 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. [FR Doc. 2010–30335 Filed 12–2–10; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES 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. DATES: 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 Food and Drug Administration, mstockstill on DSKH9S0YB1PROD with NOTICES HHS. ACTION: Hours per recordkeeper Total hours 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. AGENCY: Total annual records Notice. 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 SUMMARY: VerDate Mar<15>2010 16:09 Dec 02, 2010 Jkt 223001 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. ADDRESSES: PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 Submit electronic comments on the draft guidance to https:// 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 E:\FR\FM\03DEN1.SGM 03DEN1 Federal Register / Vol. 75, No. 232 / Friday, December 3, 2010 / Notices Drug Products; Questions and Answers.’’ This document answers questions regarding CVM’s implementation of USP <467> Residual Solvents. DEPARTMENT OF HEALTH AND HUMAN SERVICES II. Significance of Guidance [Docket No. FDA–2009–D–0533] 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. 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 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 mstockstill on DSKH9S0YB1PROD with NOTICES Persons with access to the Internet may obtain the draft guidance at either https://www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm or https://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 VerDate Mar<15>2010 16:09 Dec 02, 2010 Jkt 223001 Food and Drug Administration AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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 selfSUMMARY: PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 75483 addressed 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 https://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 E:\FR\FM\03DEN1.SGM 03DEN1

Agencies

[Federal Register Volume 75, Number 232 (Friday, December 3, 2010)]
[Notices]
[Pages 75482-75483]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30387]


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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 self-addressed 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 https://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, e-mail: 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

[[Page 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 https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or https://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
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