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68 FR 37 pgs. 8772-8773 - Draft Guidance for Industry on ComparabilityProtocols—Chemistry, Manufacturing, and Controls Information;Availability

Type: NOTICEVolume: 68Number: 37Pages: 8772 - 8773
Docket number: [Docket No. 03D-0061]
FR document: [FR Doc. 03-4311 Filed 2-20-03; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version:  PDF Version

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03D-0061]

Draft Guidance for Industry on ComparabilityProtocols-Chemistry, Manufacturing, and Controls Information;Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) isannouncing the availability of a draft guidance for industry entitled"Comparability Protocols-Chemistry, Manufacturing, and ControlsInformation." This draft document provides recommendations toapplicants on preparing and using comparability protocols for postapprovalchanges in chemistry, manufacturing, and controls (CMC) information.

DATES:

Submit written or electronic comments on thedraft guidance by June 25, 2003. General comments on agencyguidance documents are welcome at any time.

ADDRESSES:

Submit written requests for single copies ofthe draft guidance to the Office of Training and Communications, Divisionof Communications Management, Division of Drug Information (HFD-240),Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, MD20857; or to the Office of Communication, Training, and ManufacturersAssistance (HFM-40), Center for Biologics Evaluation and Research,Food and Drug Administration, 1401 Rockville Pike, Rockville, MD20852-1448 or to the Communications Staff (HFV-12), Center forVeterinary Medicine, Food and Drug Administration, 7500 Standish Pl.,Rockville, MD 20855. Send one self-addressed adhesive label to assist thatoffice in processing your requests. Submit phone requests to800-835-4709 or 301-827-1800. Submit writtencomments on the draft guidance to the Dockets Management Branch(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,Rockville, MD 20852. Submit electronic comments tohttp://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARYINFORMATION section for electronic access to the draft guidancedocument.

FOR FURTHER INFORMATION CONTACT:

Stephen Moore, Centerfor Drug Evaluation and Research (HFD-510), Food and DrugAdministration, 5600 Fishers Lane, Rockville, MD 20857,301-827-6430, or Christopher Joneckis, Center for BiologicsEvaluation and Research (HFM-1), Food and Drug Administration, 8800Rockville Pike, Rockville, MD 20892, 301-435-5681, or DennisBensley, Center for Veterinary Medicine (HFV-143), Food and DrugAdministration, 7500 Standish Pl., Rockville, MD 20855,301-827-6956.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industryentitled "Comparability Protocols-Chemistry, Manufacturing, andControls Information." This draft guidance applies to comparabilityprotocols that would be submitted in new drug applications (NDAs),abbreviated new drug applications (ANDAs), new animal drug applications(NADAs), abbreviated new animal drug applications (ANADAs), or supplementsto these applications, except for applications for protein products.Well-characterized synthetic peptides submitted in these applications areincluded within the scope of this guidance. This draft guidance alsoapplies to comparability protocols submitted in drug master files (DMFs)and veterinary master files (VMFs) that are referenced in theseapplications. A separate guidance will address comparability protocols forproteins as well as for peptide products outside the scope of this guidancethat are submitted in these applications. This separate guidance will alsoaddress comparability protocols for products submitted in biologics licenseapplications (BLAs).

This draft guidance contains information collection provisions that aresubject to review by the Office of Management and Budget (OMB) under thePaperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Thecollection of information in this guidance was approved under OMB controlnumbers 0910-0001 and 0910-0032.

This draft guidance is being issued consistent with FDA's good guidancepractices regulation (21 CFR 10.115). The draft guidance represents theagency's current thinking on "Comparability Protocols; Chemistry,Manufacturing, and Controls Information". It does not create orconfer any rights for or on any person and does not operate to bind FDA orthe public. An alternative approach may be used if such approach satisfiesthe requirements of the applicable statutes and regulations.

II. Comments

Interested persons may submit to the Dockets Management Branch (see ADDRESSES ) written or electronic comments on the draft guidance.Submit a single copy of electronic comments tohttp://www.fda.gov/dockets/ecomments or two hard copies of any writtencomments, except that individuals may submit one hard copy. Comments areto be identified with the docket number found in brackets in the heading ofthis document. The draft guidance and received comments are available forpublic examination in the Dockets Management Branch between 9 a.m. and 4p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet may obtain the draft guidance athttp://www.fda.gov/cder/guidance/index.htm,http://www.fda.gov/cber/guidelines.htm, orhttp://www.fda.gov/cvm/guidance/published.htm.

Dated: February 19, 2003.

William K. Hubbard,

Associate Commissioner for Policy and Planning.

[FR Doc. 03-4311 Filed 2-20-03; 8:45 am]

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