80 FR 64005 - Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 204 (October 22, 2015)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use.'' This guidance has been developed to provide industry with FDA's recommendations on the selection of appropriate package type terms and selection of appropriate discard statements for injectable medical products for human use, packaged in multiple-dose, single-dose, and single-patient- use containers. This guidance provides FDA's revised definitions for single-dose and multiple-dose containers, and introduces the definition of a new package type term, ``single-patient-use'' container. Marketing applications for such products include: New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), Biologics License Applications (BLAs), Premarket Approval Applications (PMAs), and Premarket Notifications under section 510(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

[Federal Register Volume 80, Number 204 (Thursday, October 22, 2015)]
[Notices]
[Pages 64005-64007]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-26849]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-3438]


Selection of the Appropriate Package Type Terms and 
Recommendations for Labeling Injectable Medical Products Packaged in 
Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human 
Use; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Selection 
of the Appropriate Package Type Terms and Recommendations for Labeling 
Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and 
Single-Patient-Use Containers for Human Use.'' This guidance has been 
developed to provide industry with FDA's recommendations on the 
selection of appropriate package type terms and selection of 
appropriate discard statements for injectable medical products for 
human use, packaged in multiple-dose, single-dose, and single-patient-
use containers. This guidance provides FDA's revised definitions for 
single-dose and multiple-dose containers, and introduces the definition 
of a new package type term, ``single-patient-use'' container. Marketing 
applications for such products include: New Drug Applications (NDAs), 
Abbreviated New Drug Applications (ANDAs), Biologics License 
Applications (BLAs), Premarket Approval Applications (PMAs), and 
Premarket Notifications under section 510(k) of the Federal Food, Drug, 
and Cosmetic Act (FD&C Act).

DATES: Although you can comment on any guidance at any time (see 21 CFR

[[Page 64006]]

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 December 21, 2015.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-D-3438 for ``Selection of the Appropriate Package Type Terms 
and Recommendations for Labeling Injectable Medical Products Packaged 
in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for 
Human Use.'' Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at http://www.regulations.gov or at the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document. The draft guidance may also be 
obtained from the Office of Communication, Outreach and Development, 
Center for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver 
Spring, MD 20993-0002. 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 240-402-8010. The 
draft guidance may also be obtained from the Office of the Center 
Director, Guidance and Policy Development, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your 
request.

FOR FURTHER INFORMATION CONTACT: Samia Nasr, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993, 301-796-3409; or Stephen Ripley, Center for 
Biologics Evaluation and Research, 10903 New Hampshire Ave., Bldg. 71, 
Rm. 7301, Silver Spring, MD 20993, 240-402-8154.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Selection of the Appropriate Package Type Terms and 
Recommendations for Labeling Injectable Medical Products Packaged in 
Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human 
Use.'' Unsafe injection practices, including the improper use of 
needles, syringes, and medication vials for more than one patient, 
threaten patient safety and have resulted in multiple blood borne 
bacterial and viral infection outbreaks. Bacterial infections have been 
transmitted to patients when single-dose containers were used 
improperly, the contents became contaminated and these contents were 
then administered to multiple patients. Failure to follow standard 
precautions and aseptic techniques has also been associated with 
several outbreaks of infections involving multiple-dose vials.
    As part of its review of medical products, FDA clears or approves 
package type terms and discard statements as part of the labeling of 
injectable medical products. FDA believes that consistent use of 
correct package type terms and discard statements for injectable 
medical products for human use will promote their proper use and 
provide a foundation for educational efforts to reduce the transmission 
of blood borne pathogens.

[[Page 64007]]

    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 current thinking of FDA on ``Selection of 
the Appropriate Package Type Terms and Recommendations for Labeling 
Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and 
Single-Patient-Use Containers for Human Use.'' It does not establish 
any rights for any person and is not binding on FDA or the public. You 
can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.

II. Electronic Access

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

III. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information 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 discussed in this draft guidance 
have been approved under OMB under the following control numbers: OMB 
control number 0910-0001 for NDAs, ANDAs, supplements to NDAs and 
ANDAs, and annual reports; OMB control number 0910-0572 for 
prescription drug product labeling; OMB control number 0910-0338 for 
BLA, BLA supplements and annual reports; OMB control number 0910-0120 
for premarket notifications (510(k)s); OMB control number 0910-0231 for 
premarket approval applications (PMAs); OMB control number 0910-0485 
for medical device labeling; and OMB control number 0910-0577 for 
prominent and conspicuous mark of manufacturers on single-use devices. 
Relevant to this collection of information, FDA published its proposed 
rule on the electronic distribution of prescribing information for 
human prescription drugs, including biological products in the Federal 
Register of December 18, 2014 (79 FR 75506). In Section VII, 
``Paperwork Reduction Act of 1995,'' FDA estimated the burden to 
design, test, and produce the label for a drug product's immediate 
container and outer container or package, as set forth in 21 CFR part 
201, including Sec.  201.100(b) and other sections in subpart A and 
subpart B.

    Dated: October 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-26849 Filed 10-21-15; 8:45 am]
BILLING CODE 4164-01-P