
[Federal Register Volume 78, Number 64 (Wednesday, April 3, 2013)]
[Notices]
[Pages 20116-20117]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07685]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0362]


Draft Guidance for Industry and Food and Drug Administration 
Staff; Glass Syringes for Delivering Drug and Biological Products: 
Technical Information To Supplement International Organization for 
Standardization Standard 11040-4; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of draft guidance for industry and FDA staff entitled 
``Glass Syringes for Delivering Drug and Biological Products: Technical 
Information to Supplement International Organization for 
Standardization (ISO) Standard 11040-4.'' These supplemental data are 
necessary for FDA to ensure the safe and effective use of glass 
syringes that comply with the ISO 11040-4 standard when connected to 
devices (``connecting devices'') that comply with the ISO 594-2 
standard.

[[Page 20117]]


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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by July 2, 2013.

ADDRESSES: Submit written requests for single printed copies of the 
draft guidance to the Office of Combination Products, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5129; Silver 
Spring, MD 20993. Send one self-addressed adhesive label to assist the 
office in processing your requests. The guidance may also be obtained 
by mail by calling the Office of Combination Products at 301-796-8930. 
See the SUPPLEMENTARY INFORMATION section for electronic access to the 
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    Submit electronic comments on the draft guidance to http://www.regulations.gov.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.

FOR FURTHER INFORMATION CONTACT: Patricia Y. Love, Office of 
Combination Products, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 32, rm. 5129, Silver Spring, MD 20993.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Glass Syringes for Delivering Drug and Biological Products: 
Technical Information to Supplement International Organization for 
Standardization (ISO) Standard 11040-4.'' This document provides 
guidance to sponsors seeking to rely on conformity to ISO Standard 
11040-4 in submissions for glass syringes products. FDA has become 
aware of adverse events and product quality events related to 
connectivity problems when certain glass syringes are used with 
connecting devices, including connecting devices to conform to the FDA-
recognized ISO 594-2 standard. Accordingly, FDA has determined that, 
for glass syringes, demonstrating conformity to the ISO 11040-4 
standard alone does not ensure that the glass syringe can be properly 
connected to connecting devices. Therefore, this guidance document 
identifies additional, technical information that should be included in 
an investigational device exemption (IDE), humanitarian device 
exemption (HDE), 510(k), or postmarket application (PMA) for a glass 
syringe product, or in an investigational new drug application (IND), a 
biologics license application (BLA), new drug application (NDA), or 
abbreviated new drug application (ANDA) for a drug or biological 
product that is delivered with such a glass syringe product, to 
demonstrate that the glass syringe can be properly connected to 
connecting devices.
    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 ``Glass 
Syringes for Delivering Drug and Biological Products: Technical 
Information to Supplement International Organization for 
Standardization (ISO) Standard 11040-4.'' 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 http://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 http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

IV. 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). The 
collections of information in 21 CFR part 314 for NDAs have been 
approved under OMB control number 0910-0001. The collections of 
information in 21 CFR part 601 for BLAs have been approved under OMB 
control number 0910-0338. The collections of information in 21 CFR part 
814 subpart B for PMAs have been approved under OMB control number 
0910-0231. The collections of information in FD&C Act subpart E for 
510(k) notifications have been approved under OMB control number 0901-
0120.

    Dated: March 28, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2013-07685 Filed 4-2-13; 8:45 am]
BILLING CODE 4160-01-P


