[Federal Register Volume 74, Number 79 (Monday, April 27, 2009)]
[Notices]
[Pages 19094-19095]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-9519]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0179]


Draft Guidance for Industry and Food and Drug Administration 
Staff: Technical Considerations for Pen, Jet, and Related Injectors 
Intended for Use With Drugs and Biological Products; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance document entitled ``Technical 
Considerations for Pen, Jet, and Related Injectors Intended for Use 
with Drugs and Biological Products.'' The draft guidance document 
provides technical and scientific information for sponsors to consider 
in developing information to support a marketing application for a pen, 
jet, or related injector device intended for use with drugs or 
biological products. The marketing application would typically be a 
premarket notification submission (510(k)) or a premarket approval 
(PMA) application for the injector alone. For a combination product 
that includes the injector, the marketing application would typically 
be a new drug application (NDA) or a biological licensing application 
(BLA).

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this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by July 27, 2009.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Office of Combination Products, 15800 Crabbs Branch 
Way, Rockville, MD 20855. 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 The draft guidance may 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 the Office of Combination Products 
at 301-427-1934 or by e-mail to [email protected]. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.
    Submit written comments on the draft guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.regulations.gov.

[[Page 19095]]


FOR FURTHER INFORMATION CONTACT:  Patricia Y. Love, Office of 
Combination Products (HFG-3), Food and Drug Administration, 15800 
Crabbs Branch Way, Rockville, MD 20855, 301-427-1934.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance document 
entitled ``Technical Considerations for Pen, Jet, and Related Injectors 
Intended for Use with Drugs and Biological Products.'' FDA is providing 
this draft guidance document to assist industry in developing technical 
and scientific information to support a marketing application for a 
pen, jet, or related injector device. The marketing application would 
typically be a 510(k) or a PMA application for the injector alone. For 
a combination product that includes the injector, the marketing 
application would typically be an NDA or a BLA. For purposes of this 
guidance, the term ``injector'' includes, but is not limited to, jet 
injectors, pen injectors, piston syringes, needle-free injectors, 
mechanically operated injectors, and injectors with computerized or 
electronic elements.

II. Significance of Guidance

    The 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 ``Technical 
Considerations for Pen, Jet, and Related Injectors Intended for Use 
with Drugs and Biological Products.'' 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.

III. Paperwork Reduction Act of 1995

    This draft 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 in 21 CFR part 807 have been approved under 
OMB control number 0910-0120. The collections of information in 21 CFR 
part 814 have been approved under OMB control number 0910-0231. The 
collections of information in 21 CFR part 314 have been approved under 
OMB control number 0910-0001. The collections of information 21 CFR 
part 601 have been approved under OMB control number 0910-0338.

IV. Comments

    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) 
written or electronic comments regarding the draft guidance. Submit a 
single copy of electronic comments or two paper copies of any mailed 
comments, except that individuals may submit one paper copy. Comments 
are to be identified with the docket number found in the brackets in 
the heading of this document. A copy of the draft guidance and received 
comments are available for public examination in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

V. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/oc/combination/ or http://www.regulations.gov.

    Dated: April 20, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-9519 Filed 4-24-09; 8:45 am]
BILLING CODE 4160-01-S