Guidance for Industry on Process Validation: General Principles and Practices; Availability, 4360-4361 [2011-1437]

Download as PDF 4360 Federal Register / Vol. 76, No. 16 / Tuesday, January 25, 2011 / Notices EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST—Continued Cost component Total cost Annualized cost Publication of Results ...................................................................................................................................................... Project Management ........................................................................................................................................................ Overhead ......................................................................................................................................................................... 149,476 70,313 175,095 66,434 31,250 77,820 Total .......................................................................................................................................................................... 600,055 266,691 Request for Comments In accordance with the above-cited Paperwork Reduction Act legislation, comments on AHRQ’s information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ healthcare research and healthcare information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ’s estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and included in the Agency’s subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record. Dated: January 3, 2011. Carolyn M. Clancy, Director. [FR Doc. 2011–1169 Filed 1–24–11; 8:45 am] BILLING CODE 4160–90–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration mstockstill on DSKH9S0YB1PROD with NOTICES [Docket No. FDA–2010–N–0370] Draft Guidance for Industry: Questions and Answers Regarding Implementation of the Menu Labeling Provisions of Section 4205 of the Patient Protection and Affordable Care Act of 2010; Withdrawal of Draft Guidance AGENCY: Food and Drug Administration, HHS. ACTION: Notice; withdrawal. The Food and Drug Administration (FDA) is announcing the SUMMARY: VerDate Mar<15>2010 18:40 Jan 24, 2011 Jkt 223001 withdrawal of a draft guidance entitled ‘‘Draft Guidance for Industry: Questions and Answers Regarding Implementation of the Menu Labeling Provisions of Section 4205 of the Patient Protection and Affordable Care Act of 2010’’ dated August 2010, that was announced in the Federal Register of August 25, 2010. FDA now intends to complete the notice and comment rulemaking process for the Patient Protection and Affordable Care Act of 2010 (hereinafter ‘‘section 4205’’) before initiating enforcement activities based, in part, on extensive comments on the draft guidance submitted to the Agency. FDA believes that this approach to implementing section 4205 will minimize uncertainty and confusion among all interested persons. The withdrawal is effective January 25, 2011. DATES: FOR FURTHER INFORMATION CONTACT: Geraldine A. June, Center for Foods Safety and Applied Nutrition (HFS– 820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301–436–2371. In a notice published in the Federal Register of August 25, 2010 (75 FR 52426), FDA announced the availability of a draft guidance entitled ‘‘Draft Guidance for Industry: Questions and Answers Regarding Implementation of the Menu Labeling Provisions of Section 4205 of the Patient Protection and Affordable Care Act of 2010.’’ As stated in the draft guidance, certain provisions of section 4205 became requirements immediately upon enactment of the law. FDA recognized that industry may need additional guidance from the Agency and time to comply with these provisions. As a result, FDA stated that it expected to refrain from initiating enforcement action against establishments that are subject to, but not in compliance with, the provisions of section 4205 that became requirements immediately upon enactment of the law until a time period established in the draft guidance. FDA also stated that it anticipated issuing the guidance in December 2010. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 Based, in part, on extensive comments on the draft guidance submitted to the Agency, FDA now intends to complete the notice-and-comment rulemaking process for section 4205 before initiating enforcement activities. As noted in the draft guidance, FDA is required to issue proposed regulations to carry out provisions of section 4205 no later than March 23, 2011. FDA intends to meet this statutory deadline. In the course of developing the proposed rule, the Agency has considered the comments received on the draft guidance. FDA will then review the comments it receives on the proposed rule and issue a final rule expeditiously. FDA believes that this approach to implementing section 4205 will minimize uncertainty and confusion among all interested persons. The Agency also believes that expeditious completion of the rulemaking process will most rapidly lead to full and consistent availability of the newly required nutrition information for consumers. For these reasons, FDA is at this time withdrawing the draft guidance entitled ‘‘Draft Guidance for Industry: Questions and Answers Regarding Implementation of the Menu Labeling Provisions of Section 4205 of the Patient Protection and Affordable Care Act of 2010.’’ Dated: January 20, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–1530 Filed 1–21–11; 12:00 pm] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–D–0559] Guidance for Industry on Process Validation: General Principles and Practices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the SUMMARY: E:\FR\FM\25JAN1.SGM 25JAN1 mstockstill on DSKH9S0YB1PROD with NOTICES Federal Register / Vol. 76, No. 16 / Tuesday, January 25, 2011 / Notices availability of a guidance for industry entitled ‘‘Process Validation: General Principles and Practices.’’ This guidance provides information for the pharmaceutical industry on the elements of process validation for the manufacture of human and animal drug and biological products, including active pharmaceutical ingredients (APIs). The guidance is intended to provide clear and consistent communication of regulatory expectations and to promote voluntary compliance with current FDA requirements. This guidance revises and replaces the guidance for industry entitled ‘‘Guideline on General Principles of Process Validation,’’ dated May 1987. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of this 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 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. The guidance may also be obtained by mail by calling CBER at 1–800–835–4709 or 301–827–1800. Send one self-addressed adhesive label to assist that office in processing your requests. 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: Brian Hasselbalch, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 4364, Silver Spring, MD 20993–0002, 301– 796–3279; or Grace McNally, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 4374, Silver Spring, MD 20993–0002, 301– 796–3286; 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 VerDate Mar<15>2010 18:40 Jan 24, 2011 Jkt 223001 Dennis Bensley, Center for Veterinary Medicine (HFV–140), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276–8268. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Process Validation: General Principles and Practices.’’ This guidance document provides guidance to the pharmaceutical industry on the elements of process validation for the manufacture of human and animal drug and biological products, including APIs. This guidance describes process validation activities in three stages: • In Stage 1, Process Design, the commercial process is defined based on knowledge gained through development and scale-up activities. • In Stage 2, Process Qualification, the process design is evaluated and assessed to determine if the process is capable of reproducible commercial manufacturing. • In Stage 3, Continued Process Verification, ongoing assurance is gained during routine production that the process remains in a state of control. In addition to discussing activities typical of each stage of process validation, the guidance provides recommendations regarding appropriate documentation and analytical methods to be used during process validation. In the Federal Register of November 18, 2008 (73 FR 68431), FDA announced the availability of a draft guidance of the same title and gave interested persons the opportunity to submit comments by January 20, 2009. In the Federal Register of February 13, 2009 (74 FR 7237), the Agency reopened the comment period to March 16, 2009. The Agency received public comments from a broad spectrum of the pharmaceutical industry. In response to comments received on the draft guidance, the Agency added a glossary of terms and clarified or added more specific guidance on certain issues. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency’s current thinking on the general principles and practices of process validation. 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. PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 4361 II. Paperwork Reduction Act of 1995 This guidance contains information collection provisions that 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 requested in the guidance are covered under FDA regulations at 21 CFR part 211, 21 CFR 314.70, and 21 CFR 601.12 and are approved under OMB control numbers 0910–0139, 0910–0001 and 0910–0338, respectively. III. 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. 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: January 19, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–1437 Filed 1–24–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review: Comment Request Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35). To request a copy of the clearance requests submitted to E:\FR\FM\25JAN1.SGM 25JAN1

Agencies

[Federal Register Volume 76, Number 16 (Tuesday, January 25, 2011)]
[Notices]
[Pages 4360-4361]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-1437]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0559]


Guidance for Industry on Process Validation: General Principles 
and Practices; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the

[[Page 4361]]

availability of a guidance for industry entitled ``Process Validation: 
General Principles and Practices.'' This guidance provides information 
for the pharmaceutical industry on the elements of process validation 
for the manufacture of human and animal drug and biological products, 
including active pharmaceutical ingredients (APIs). The guidance is 
intended to provide clear and consistent communication of regulatory 
expectations and to promote voluntary compliance with current FDA 
requirements. This guidance revises and replaces the guidance for 
industry entitled ``Guideline on General Principles of Process 
Validation,'' dated May 1987.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of this 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 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. The guidance may 
also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-
1800. Send one self-addressed adhesive label to assist that office in 
processing your requests. 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: 
Brian Hasselbalch, Center for Drug Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 4364, 
Silver Spring, MD 20993-0002, 301-796-3279; or
Grace McNally, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 4374, Silver 
Spring, MD 20993-0002, 301-796-3286; 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
Dennis Bensley, Center for Veterinary Medicine (HFV-140), Food and Drug 
Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8268.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Process Validation: General Principles and Practices.'' This 
guidance document provides guidance to the pharmaceutical industry on 
the elements of process validation for the manufacture of human and 
animal drug and biological products, including APIs.
    This guidance describes process validation activities in three 
stages:
     In Stage 1, Process Design, the commercial process is 
defined based on knowledge gained through development and scale-up 
activities.
     In Stage 2, Process Qualification, the process design is 
evaluated and assessed to determine if the process is capable of 
reproducible commercial manufacturing.
     In Stage 3, Continued Process Verification, ongoing 
assurance is gained during routine production that the process remains 
in a state of control.
    In addition to discussing activities typical of each stage of 
process validation, the guidance provides recommendations regarding 
appropriate documentation and analytical methods to be used during 
process validation.
    In the Federal Register of November 18, 2008 (73 FR 68431), FDA 
announced the availability of a draft guidance of the same title and 
gave interested persons the opportunity to submit comments by January 
20, 2009. In the Federal Register of February 13, 2009 (74 FR 7237), 
the Agency reopened the comment period to March 16, 2009. The Agency 
received public comments from a broad spectrum of the pharmaceutical 
industry. In response to comments received on the draft guidance, the 
Agency added a glossary of terms and clarified or added more specific 
guidance on certain issues.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on the general principles and practices of 
process validation. 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. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that 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 requested in the guidance are covered under 
FDA regulations at 21 CFR part 211, 21 CFR 314.70, and 21 CFR 601.12 
and are approved under OMB control numbers 0910-0139, 0910-0001 and 
0910-0338, respectively.

III. 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.

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: January 19, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-1437 Filed 1-24-11; 8:45 am]
BILLING CODE 4160-01-P
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