Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled “Guidance for Industry: Bar Code Label Requirements—Questions and Answers (Question 12 Update)” dated August 2010. This draft guidance provides you, manufacturers of a licensed vaccine, with advice concerning compliance with the bar code label requirements. In this guidance, FDA is proposing to amend our response to question 12 (Q12) in the “Bar Code Label Requirements—Questions and Answers” guidance dated October 2006 (Bar Code Guidance), to provide recommendations to manufacturers of licensed vaccines in connection with the use of alternative coding technologies. When this guidance is finalized, we intend to incorporate the revised response to Q12 into the Bar Code Guidance, but otherwise continue with our recommendations for bar code label requirements as currently provided in the Bar Code Guidance.
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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments Start Printed Page 54348on the draft guidance by November 8, 2010.
Submit written requests for single copies of the draft guidance to the Office of Communication, Outreach and Development (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401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 The draft guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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.Start Further Info
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.End Further Info End Preamble Start Supplemental Information
FDA is announcing the availability of a draft document entitled “Guidance for Industry: Bar Code Label Requirements—Questions and Answers (Question 12 Update)” dated August 2010. FDA regulations require that certain human drug and biological product labels contain a bar code (§ 201.25 (21 CFR 201.25)). This draft guidance provides you, manufacturers of a licensed vaccine, with advice concerning compliance with the bar code label requirements. Previously, FDA issued questions and answers regarding how the bar code label requirements apply to specific products or circumstances in the Bar Code Guidance (October 5, 2006, 71 FR 58739). In this guidance, FDA is proposing to amend our response to question 12 (Q12) in the Bar Code Guidance to provide recommendations to manufacturers of licensed vaccines in connection with the use of alternative coding technologies. We are revising our response because we believe that an alternative regulatory program, comprised of alternative technology such as two dimensional symbology, could render the use of linear bar codes unnecessary for patient safety and could enhance health care providers' ability to comply with the National Childhood Vaccine Injury Act of 1986 (Public Law 99-660) (42 U.S.C. 300aa-25(a))). We would consider granting a request for exemption to the bar code requirement under § 201.25(d)(ii) in connection with such use.
II. Paperwork Reduction Act of 1995
The draft guidance refers to previously approved collections of information found in FDA regulations. The collection of information in 21 CFR part 201 has been approved under OMB control number 0910-0537.
The draft guidance is being distributed for comment purposes only and is not intended for implementation at this time. 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 draft guidance at either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.Start Signature
Dated: August 16, 2010.
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-22169 Filed 9-3-10; 8:45 am]
BILLING CODE 4160-01-S