Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements; Availability, 31943-31944 [2013-12539]

Download as PDF 31943 Federal Register / Vol. 78, No. 102 / Tuesday, May 28, 2013 / Notices This current 60-Day Federal Register Notice covers two new instruments: ANNUAL BURDEN: CURRENT REQUEST Annual number of respondents Activity/respondent Average burden per response (hours) Number of responses per respondent Total annual burden hours IMPACT Responsible Fatherhood Grantee Impact Evaluation (19) Follow-up survey: Study participants ..................................................................................... 1,600 1 0.75 1,200 Healthy Marriage Grantee Impact Evaluation 1,600 1 0.75 1,200 Total ................................................................................................... mstockstill on DSK4VPTVN1PROD with NOTICES (20) RF study MIS: Study participants ..................................................................................... ........................ ........................ ........................ 2,400 Estimated Total Annual Burden Hours (for instruments previously approved and currently in use, instruments currently under review, and those associated with this 60-Day Notice): 15,516. In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L’Enfant Promenade SW., Washington, DC 20447, Attn: OPRE Reports Clearance Officer. Email address: OPREinfocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to VerDate Mar<15>2010 17:46 May 24, 2013 Jkt 229001 comments and suggestions submitted within 60 days of this publication. Steven M. Hanmer, Reports Clearance Officer. [FR Doc. 2013–12588 Filed 5–24–13; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–D–0558] Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements; 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 entitled ‘‘Contract Manufacturing Arrangements for Drugs: Quality Agreements.’’ This guidance describes our current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (CGMP). In particular, we describe how parties involved in the contract manufacturing of drugs can utilize Quality Agreements to delineate their responsibilities and assure drug quality, safety, and efficacy. 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 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 29, 2013. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993–0002; or Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448; or Communications Staff (HFV–12), Center for Veterinary Medicine (CVM), 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 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: Paula Katz, Center for Drug Evaluation and Research, Bldg. 51, Rm. 4314, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301–796–6972; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852–1448, 301–827–6210; or Jonathan Bray, Center for Veterinary Medicine (HFV–232), E:\FR\FM\28MYN1.SGM 28MYN1 31944 Federal Register / Vol. 78, No. 102 / Tuesday, May 28, 2013 / Notices Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240– 276–9228. SUPPLEMENTARY INFORMATION: mstockstill on DSK4VPTVN1PROD with NOTICES I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Contract Manufacturing Arrangements for Drugs: Quality Agreements.’’ This draft guidance describes the FDA’s current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in the contract manufacturing of drugs subject to CGMP. Although written Quality Agreements are not explicitly required under existing CGMP regulations for human drugs and do not relieve any party to a contract of their responsibilities under CGMPs or under the Federal Food, Drug, and Cosmetic Act, this draft guidance explains how Owners and Contracted Facilities can draw on quality management principles to carry out the complicated process of contract drug manufacturing by defining, establishing, and documenting the responsibilities of all parties involved in drug manufacturing, testing, or other support operations. In particular, this guidance describes FDA’s recommendation that Owners and Contracted Facilities implement written Quality Agreements as a tool to delineate responsibilities and assure the quality, safety, and effectiveness of drug products. We are considering including examples or references to examples of Quality Agreements in the guidance. Stakeholders are encouraged to provide specific comments on publicly available and useful Quality Agreements for contract arrangements for the manufacturing of drugs. This 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. II. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the VerDate Mar<15>2010 17:46 May 24, 2013 Jkt 229001 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, and will be posted to the docket at https:// www.regulations.gov. III. The 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) and have been approved under OMB control numbers 0910–0014 and 0910–0001. IV. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm, https://www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm, or https://www.regulations.gov. Dated: May 21, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–12539 Filed 5–24–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–D–0347] International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 13 on Bulk Density and Tapped Density of Powders General Chapter; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ‘‘Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 13: Bulk Density and Tapped Density of Powders General Chapter.’’ The guidance was prepared under the auspices of the PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Bulk Density and Tapped Density of Powders General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. The guidance is in the form of an annex to the core guidance on the Q4B process entitled ‘‘Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions (core ICH Q4B guidance). 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 Division of Drug Information (HFD– 240), Center for Drug Evaluation and Research (CDER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993–0002, or the Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852–1448. Send one self-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: Regarding the guidance: Robert King, Sr., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4150, Silver Spring, MD 20993–0002, 301–796–1242; or Stephen Ripley, Center for Biologics E:\FR\FM\28MYN1.SGM 28MYN1

Agencies

[Federal Register Volume 78, Number 102 (Tuesday, May 28, 2013)]
[Notices]
[Pages 31943-31944]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-12539]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0558]


Draft Guidance for Industry on Contract Manufacturing 
Arrangements for Drugs: Quality Agreements; 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 entitled ``Contract 
Manufacturing Arrangements for Drugs: Quality Agreements.'' This 
guidance describes our current thinking on defining, establishing, and 
documenting the responsibilities of each party (or all parties) 
involved in the contract manufacturing of drugs subject to Current Good 
Manufacturing Practice (CGMP). In particular, we describe how parties 
involved in the contract manufacturing of drugs can utilize Quality 
Agreements to delineate their responsibilities and assure drug quality, 
safety, and efficacy.

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 either electronic or written comments on the draft 
guidance by July 29, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002; or 
Office of Communication, Outreach and Development (HFM-40), Center for 
Biologics Evaluation and Research (CBER), Food and Drug Administration, 
1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448; or 
Communications Staff (HFV-12), Center for Veterinary Medicine (CVM), 
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: Paula Katz, Center for Drug Evaluation 
and Research, Bldg. 51, Rm. 4314, Food and Drug Administration, 10903 
New Hampshire Ave., Silver Spring, MD 20993, 301-796-6972; or Stephen 
Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and 
Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 
20852-1448, 301-827-6210; or Jonathan Bray, Center for Veterinary 
Medicine (HFV-232),

[[Page 31944]]

Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 
240-276-9228.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Contract Manufacturing Arrangements for Drugs: Quality 
Agreements.'' This draft guidance describes the FDA's current thinking 
on defining, establishing, and documenting the responsibilities of each 
party (or all parties) involved in the contract manufacturing of drugs 
subject to CGMP. Although written Quality Agreements are not explicitly 
required under existing CGMP regulations for human drugs and do not 
relieve any party to a contract of their responsibilities under CGMPs 
or under the Federal Food, Drug, and Cosmetic Act, this draft guidance 
explains how Owners and Contracted Facilities can draw on quality 
management principles to carry out the complicated process of contract 
drug manufacturing by defining, establishing, and documenting the 
responsibilities of all parties involved in drug manufacturing, 
testing, or other support operations. In particular, this guidance 
describes FDA's recommendation that Owners and Contracted Facilities 
implement written Quality Agreements as a tool to delineate 
responsibilities and assure the quality, safety, and effectiveness of 
drug products.
    We are considering including examples or references to examples of 
Quality Agreements in the guidance. Stakeholders are encouraged to 
provide specific comments on publicly available and useful Quality 
Agreements for contract arrangements for the manufacturing of drugs.
    This 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.

II. Comments

    Interested persons may submit either electronic comments regarding 
this document to https://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of 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, and will be posted to the docket at https://www.regulations.gov.

III. The 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) and 
have been approved under OMB control numbers 0910-0014 and 0910-0001.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, or https://www.regulations.gov.

    Dated: May 21, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-12539 Filed 5-24-13; 8:45 am]
BILLING CODE 4160-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.