[Federal Register Volume 62, Number 164 (Monday, August 25, 1997)] [Notices] [Pages 44975-44976] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-22421] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 97D-3010] Draft Guidance for Industry on Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled ``Guidance for Industry on Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts (July 1997).'' This draft guidance document is intended to provide information to manufacturers regarding the development of stability studies to determine the shelf life of standardized grass pollen extracts to help ensure the safety, purity, and potency of these products. DATES: Written comments may be submitted at any time, however, to ensure comments are considered for the next revision they should be submitted by October 24, 1997. ADDRESSES: Submit written requests for single copies of ``Guidance for Industry on Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts (July 1997)'' to the Center for Biologics Evaluation and Research, Food and Drug Administration, Office of Communication, Training, and Manufacturers Assistance (HFM-40), 1401 Rockville Pike, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist that office in processing your request. The draft guidance document may also be obtained by mail by calling the CBER Voice Information System at 1-800-835-4709 or 301-827-1800, or by fax by calling the FAX Information System at 1-888-CBER-FAX or 301-827- 3844. Submit written comments on the draft guidance document to the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: Timothy W. Beth, Center for Biologics Evaluation and Research (HFM-630), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-594-3074. SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a draft guidance document entitled ``Guidance for Industry on Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts (July 1997).'' The draft guidance document provides a discussion of issues that should be considered in the development of stability protocols for allergenic extracts derived from grass pollen for diagnostic and immunotherapeutic uses. The draft guidance document is intended to provide information to manufacturers regarding stability studies on grass pollen extracts. Such stability studies are used to empirically determine the shelf life of the product. This draft guidance document does not, however, change lot release criteria for these products. Issues addressed in the draft guidance document include but are not limited to: (1) Current lot release criteria, (2) lot release versus stability protocol, (3) modified stability protocol, (4) retesting, (5) dealing with test failure, and (6) extension of dating. As with other guidance documents, FDA does not intend this draft guidance document to be all-inclusive and cautions that not all information may be applicable to all situations. The draft guidance document is intended to provide information and does not set forth requirements. The methods and procedures presented in the draft guidance document are suggestions. FDA anticipates that sponsors and investigators may develop alternative methods and procedures and discuss them with FDA. FDA may find those alternative methods and procedures acceptable. FDA recognizes that [[Page 44976]] advances will continue in the area of allergenic extracts and that this document may become outdated as those advances occur. This draft guidance document represents the agency's current thinking on testing limits in stability protocols for standardized grass pollen extracts. 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 statute, regulations, or both. Interested persons may submit written comments on the draft guidance document to the Dockets Management Branch (address above). Two copies of any comments are to be submitted, except that individuals may submit one. Requests and comments should be identified with the docket number found in brackets in the heading of this document. The draft guidance document and received comments are available for public examination in the office above between 9 a.m. and 4 p.m., Monday through Friday. Comments received will be considered in determining whether further revision of the draft guidance document is warranted. Persons with access to the INTERNET may obtain the draft guidance document by using the World Wide Web (WWW). For WWW access, connect to CBER at ``http://www.fda.gov/cber/guidelines.htm''. Dated: August 15, 1997. William K. Hubbard, Associate Commissioner for Policy Coordination. [FR Doc. 97-22421 Filed 8-22-97; 8:45 am] BILLING CODE 4160-01-F