[Federal Register Volume 83, Number 192 (Wednesday, October 3, 2018)]
[Notices]
[Pages 49933-49934]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21531]


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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; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final 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 finalizes 
the draft guidance issued October 22, 2015, which provides 
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.

DATES: The announcement of the guidance is published in the Federal 
Register on October 3, 2018.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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 https://www.regulations.gov or at the Dockets Management Staff 
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

[[Page 49934]]

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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of this 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, or Office of 
Communication, Outreach, and Development, Center for Biologics 
Evaluation and Research, 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 that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Yana Mille, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 4166, Silver Spring, MD 20993, 301-796-1577; or Stephen 
Ripley, Center for Biologics Evaluation and Research, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a 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 use of needles or 
syringes for more than one patient or the improper use of medication 
vials for more than one patient, threaten patient safety and have 
resulted in multiple blood borne bacterial and viral infection 
outbreaks. Bacterial and viral 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. All the stakeholder comments on the draft 
guidance were carefully reviewed and, where appropriate, clarifying 
edits were made in the final guidance. The major change made in 
response to stakeholder comments on the draft guidance was the addition 
of a subsection titled ``Addition of a discard statement or changes to 
an existing discard statement'' to the ``Labeling Requirements and 
Recommendations'' section of the final guidance.
    Specifically, this guidance provides FDA's revised definitions for 
single-dose and multiple-dose containers as well as the definition for 
the new package type term single-patient-use container. These 
containers may be part of a drug, a biological product, or a 
combination product assigned to FDA's Center for Drug Evaluation and 
Research, Center for Biologics Evaluation and Research, or certain 
combination products assigned to FDA's Center for Devices and 
Radiological Health. Marketing applications for such products include 
new drug applications (NDAs), abbreviated new drug applications 
(ANDAs), biologics license applications (BLAs), premarket approval 
applications (PMAs), premarket notifications under the Federal Food, 
Drug, and Cosmetic Act (FD&C Act), and requests for classification 
submitted under the FD&C Act De Novo request.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on the 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. This guidance is not subject to Executive 
Order 12866.

II. 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 guidance have 
been approved under the following OMB 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 
PMAs; OMB control number 0910-0485 for medical device labeling; and OMB 
control number 0910-0577 for prominent and conspicuous mark of 
manufactures on single-use devices.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov.

    Dated: September 27, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21531 Filed 10-2-18; 8:45 am]
 BILLING CODE 4164-01-P


