83_FR_50125 83 FR 49933 - 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

83 FR 49933 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 192 (October 3, 2018)

Page Range49933-49934
FR Document2018-21531

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 This guidance finalizes the draft guidance issued October 22, 2015, which provides recommendations on the selection of appropriate package type terms and selection of appropriate discard statements for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.

Federal Register, Volume 83 Issue 192 (Wednesday, October 3, 2018) 
[Federal Register Volume 83, Number 192 (Wednesday, October 3, 2018)]
[Notices]
[Pages 49933-49934]
From the Federal Register Online  [www.thefederalregister.org]
[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the draft guidance issued October 22, 2015, which provides 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.thefederalregister.org/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

Federal Register / Vol. 83, No. 192 / Wednesday, October 3, 2018 / Notices 49933 development applicants should III. Electronic Access including attachments, to https:// incorporate pediatric patients for Persons with access to the internet www.regulations.gov will be posted to development of systemic drugs for AD. may obtain the guidance at either the docket unchanged. Because your This guidance has only minor editorial https://www.fda.gov/Drugs/Guidance comment will be made public, you are changes and finalizes the draft guidance ComplianceRegulatoryInformation/ solely responsible for ensuring that your of the same name issued on April 9, Guidances/default.htm, https:// comment does not include any 2018 (83 FR 15157) to which no www.fda.gov/BiologicsBloodVaccines/ confidential information that you or a comments were received. GuidanceComplianceRegulatory third party may not wish to be posted, This guidance is being issued such as medical information, your or Information/Guidances/default.htm, or consistent with FDA’s good guidance anyone else’s Social Security number, or https://www.regulations.gov. practices regulation (21 CFR 10.115). confidential business information, such The guidance represents the current Dated: September 27, 2018. as a manufacturing process. Please note thinking of FDA on ‘‘Atopic Dermatitis: Leslie Kux, that if you include your name, contact Timing of Pediatric Studies During Associate Commissioner for Policy. information, or other information that Development of Systemic Drugs.’’ It [FR Doc. 2018–21519 Filed 10–2–18; 8:45 am] identifies you in the body of your does not establish any rights for any BILLING CODE 4164–01–P comments, that information will be person and is not binding on FDA or the posted on https://www.regulations.gov. public. You can use an alternative • If you want to submit a comment approach if it satisfies the requirements DEPARTMENT OF HEALTH AND with confidential information that you of the applicable statutes and HUMAN SERVICES do not wish to be made available to the regulations. This guidance is not subject public, submit the comment as a to Executive Order 12866. Food and Drug Administration written/paper submission and in the [Docket No. FDA–2015–D–3438] manner detailed (see ‘‘Written/Paper II. Paperwork Reduction Act of 1995 Submissions’’ and ‘‘Instructions’’). This guidance refers to previously Selection of the Appropriate Package approved collections of information Written/Paper Submissions Type Terms and Recommendations for found in FDA regulations. These Labeling Injectable Medical Products Submit written/paper submissions as collections of information are subject to Packaged in Multiple-Dose, Single- follows: review by the Office of Management and • Mail/Hand Delivery/Courier (for Dose, and Single-Patient-Use Budget (OMB) under the Paperwork written/paper submissions): Dockets Containers for Human Use; Guidance Reduction Act of 1995 (44 U.S.C. 3501– Management Staff (HFA–305), Food and for Industry; Availability 3520). The collections of information Drug Administration, 5630 Fishers related to the burden on the submission AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852. of new drug applications in 21 CFR HHS. • For written/paper comments 314.50(d)(7), including pediatric use ACTION: Notice of availability. submitted to the Dockets Management information, have been approved under Staff, FDA will post your comment, as OMB control number 0910–0001. The SUMMARY: The Food and Drug well as any attachments, except for collections of information related to the Administration (FDA or Agency) is information submitted, marked and burden on the submission of announcing the availability of a final identified, as confidential, if submitted investigational new drug applications in guidance for industry entitled as detailed in ‘‘Instructions.’’ § 312.47(b)(1)(iv) (21 CFR ‘‘Selection of the Appropriate Package Instructions: All submissions received 312.47(b)(1)(iv)), including plans for Type Terms and Recommendations for must include the Docket No. FDA– pediatric studies, have been approved Labeling Injectable Medical Products 2015–D–3438 for ‘‘Selection of the under OMB control number 0910–0014. Packaged in Multiple-Dose, Single-Dose, Appropriate Package Type Terms and The collections of information related to and Single-Patient-Use Containers for Recommendations for Labeling the burden for requesting meetings with Human Use.’’ This guidance finalizes Injectable Medical Products Packaged in FDA about drug development programs the draft guidance issued October 22, Multiple-Dose, Single-Dose, and Single- in §§ 312.47 and 312.82 have been 2015, which provides recommendations Patient-Use Containers for Human Use.’’ approved under OMB control number on the selection of appropriate package Received comments will be placed in 0910–0429. The collections of type terms and selection of appropriate the docket and, except for those information related to the burden on the discard statements for injectable submitted as ‘‘Confidential submission of information about medical products for human use, Submissions,’’ publicly viewable at expedited review programs for serious packaged in multiple-dose, single-dose, https://www.regulations.gov or at the conditions and the guidance for and single-patient-use containers. Dockets Management Staff between 9 industry entitled ‘‘Expedited Programs DATES: The announcement of the a.m. and 4 p.m., Monday through for Serious Conditions—Drugs and guidance is published in the Federal Friday. Biologics’’ (available at https:// Register on October 3, 2018. • Confidential Submissions—To www.fda.gov/ucm/groups/fdagov- ADDRESSES: You may submit either submit a comment with confidential public/@fdagov-drugs-gen/documents/ electronic or written comments on information that you do not wish to be document/ucm358301.pdf) have been Agency guidances at any time as made publicly available, submit your approved under OMB control number follows: comments only as a written/paper 0910–0765. The collections of submission. You should submit two daltland on DSKBBV9HB2PROD with NOTICES information referenced in this guidance Electronic Submissions copies total. One copy will include the that are related to the burden on the Submit electronic comments in the information you claim to be confidential submission of biologics license following way: with a heading or cover note that states applications covered under 21 CFR part • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS 601, including pediatric use https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The information, have been approved under instructions for submitting comments. Agency will review this copy, including OMB control number 0910–0338. Comments submitted electronically, the claimed confidential information, in VerDate Sep<11>2014 19:12 Oct 02, 2018 Jkt 247001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\03OCN1.SGM 03OCN1

49934 Federal Register / Vol. 83, No. 192 / Wednesday, October 3, 2018 / Notices its consideration of comments. The I. Background applications (PMAs), premarket second copy, which will have the FDA is announcing the availability of notifications under the Federal Food, claimed confidential information a guidance for industry entitled Drug, and Cosmetic Act (FD&C Act), and redacted/blacked out, will be available ‘‘Selection of the Appropriate Package requests for classification submitted for public viewing and posted on Type Terms and Recommendations for under the FD&C Act De Novo request. https://www.regulations.gov. Submit Labeling Injectable Medical Products This guidance is being issued both copies to the Dockets Management Packaged in Multiple-Dose, Single-Dose, consistent with FDA’s good guidance Staff. If you do not wish your name and and Single-Patient-Use Containers for practices regulation (21 CFR 10.115). contact information to be made publicly Human Use.’’ Unsafe injection practices, The guidance represents the current available, you can provide this including the use of needles or syringes thinking of FDA on the selection of the information on the cover sheet and not for more than one patient or the appropriate package type terms and in the body of your comments and you improper use of medication vials for recommendations for labeling injectable must identify this information as more than one patient, threaten patient medical products packaged in multiple- ‘‘confidential.’’ Any information marked safety and have resulted in multiple dose, single-dose, and single-patient-use as ‘‘confidential’’ will not be disclosed blood borne bacterial and viral infection except in accordance with 21 CFR 10.20 containers for human use. It does not outbreaks. Bacterial and viral infections establish any rights for any person and and other applicable disclosure law. For have been transmitted to patients when more information about FDA’s posting is not binding on FDA or the public. single-dose containers were used of comments to public dockets, see 80 You can use an alternative approach if improperly, the contents became FR 56469, September 18, 2015, or access it satisfies the requirements of the contaminated, and these contents were the information at: https://www.gpo.gov/ applicable statutes and regulations. This then administered to multiple patients. fdsys/pkg/FR-2015-09-18/pdf/2015- guidance is not subject to Executive Failure to follow standard precautions 23389.pdf. and aseptic techniques has also been Order 12866. Docket: For access to the docket to associated with several outbreaks of II. The Paperwork Reduction Act of read background documents or the infections involving multiple-dose vials. 1995 electronic and written/paper comments As part of its review of medical received, go to https:// products, FDA clears or approves This guidance refers to previously www.regulations.gov and insert the package type terms and discard approved collections of information that docket number, found in brackets in the statements as part of the labeling of are subject to review by the Office of heading of this document, into the injectable medical products. FDA Management and Budget (OMB) under ‘‘Search’’ box and follow the prompts believes that consistent use of correct the Paperwork Reduction Act of 1995 and/or go to the Dockets Management package type terms and discard (44 U.S.C. 3501–3520). The collections Staff, 5630 Fishers Lane, Rm. 1061, statements for injectable medical of information discussed in this Rockville, MD 20852. products for human use will promote guidance have been approved under the their proper use and provide a following OMB control numbers: OMB You may submit comments on any foundation for educational efforts to guidance at any time (see 21 CFR control number 0910–0001 for NDAs, reduce the transmission of blood borne ANDAs, supplements to NDAs and 10.115(g)(5)). pathogens. All the stakeholder ANDAs, and annual reports; OMB Submit written requests for single comments on the draft guidance were control number 0910–0572 for copies of this guidance to the Division carefully reviewed and, where prescription drug product labeling; of Drug Information, Center for Drug appropriate, clarifying edits were made OMB control number 0910–0338 for Evaluation and Research, Food and in the final guidance. The major change BLA, BLA supplements, and annual Drug Administration, 10001 New made in response to stakeholder reports; OMB control number 0910– Hampshire Ave., Hillandale Building, comments on the draft guidance was the 0120 for premarket notifications 4th Floor, Silver Spring, MD 20993– addition of a subsection titled (510(k)s); OMB control number 0910– 0002, or Office of Communication, ‘‘Addition of a discard statement or 0231 for PMAs; OMB control number Outreach, and Development, Center for changes to an existing discard 0910–0485 for medical device labeling; Biologics Evaluation and Research, statement’’ to the ‘‘Labeling and OMB control number 0910–0577 for Food and Drug Administration, 10903 Requirements and Recommendations’’ prominent and conspicuous mark of New Hampshire Ave., Bldg. 71, Rm. section of the final guidance. manufactures on single-use devices. 3128, Silver Spring, MD 20993–0002. Specifically, this guidance provides Send one self-addressed adhesive label FDA’s revised definitions for single- III. Electronic Access to assist that office in processing your dose and multiple-dose containers as requests. See the SUPPLEMENTARY well as the definition for the new Persons with access to the internet INFORMATION section for electronic package type term single-patient-use may obtain the guidance at either access to the guidance document. container. These containers may be part https://www.fda.gov/Drugs/Guidance of a drug, a biological product, or a ComplianceRegulatoryInformation/ FOR FURTHER INFORMATION CONTACT: combination product assigned to FDA’s Guidances/default.htm, https:// Yana Mille, Center for Drug Evaluation www.fda.gov/BiologicsBloodVaccines/ Center for Drug Evaluation and and Research, Food and Drug GuidanceComplianceRegulatory Research, Center for Biologics Administration, 10903 New Hampshire Evaluation and Research, or certain Information/default.htm, or https:// daltland on DSKBBV9HB2PROD with NOTICES Ave., Bldg. 51, Rm. 4166, Silver Spring, combination products assigned to FDA’s www.regulations.gov. MD 20993, 301–796–1577; or Stephen Center for Devices and Radiological Dated: September 27, 2018. Ripley, Center for Biologics Evaluation Health. Marketing applications for such and Research, 10903 New Hampshire Leslie Kux, products include new drug applications Ave., Bldg. 71, Rm. 7301, Silver Spring, Associate Commissioner for Policy. (NDAs), abbreviated new drug MD 20993–0002, 240–402–7911. [FR Doc. 2018–21531 Filed 10–2–18; 8:45 am] applications (ANDAs), biologics license SUPPLEMENTARY INFORMATION: applications (BLAs), premarket approval BILLING CODE 4164–01–P VerDate Sep<11>2014 18:05 Oct 02, 2018 Jkt 247001 PO 00000 Frm 00030 Fmt 4703 Sfmt 9990 E:\FR\FM\03OCN1.SGM 03OCN1


Document Created: 2018-10-03 02:30:05
Document Modified: 2018-10-03 02:30:05
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesThe announcement of the guidance is published in the Federal Register on October 3, 2018.
ContactYana 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.
FR Citation83 FR 49933 
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