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Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use; Draft Guidance for Industry; Availability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)

Page Range		64005-64007
FR Document		2015-26849

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose,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 Issue 204 (Thursday, October 22, 2015)

[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Use; Draft Guidance for Industry; Availability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.

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

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the availability of a draft guidance for industry entitled ``Selection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

Federal Register / Vol. 80, No. 204 / Thursday, October 22, 2015 / Notices 64005

information collection described above. other forms of information technology. uniform grant application format for
Copies of the proposed collection of Consideration will be given to applicants to submit project information
information can be obtained and comments and suggestions submitted in response to ACF discretionary
comments may be forwarded by writing within 60 days of this publication. funding opportunity announcements.
to the Administration for Children and ACF uses this information, along with
Robert Sargis,
Families, Office of Planning, Research other OMB-approved information
and Evaluation, 370 L’Enfant Reports Clearance Officer. collections (Standard Forms), to
Promenade SW., Washington, DC 20447, [FR Doc. 2015–26843 Filed 10–21–15; 8:45 am] evaluate and rank applications. Use of
Attn: ACF Reports Clearance Officer. BILLING CODE 4184–01–P the UPD helps to protect the integrity of
Email address: infocollection@ ACF’s award selection process. All ACF
acf.hhs.gov. All requests should be discretionary grant programs are
identified by the title of the information DEPARTMENT OF HEALTH AND required to use this application format.
collection. HUMAN SERVICES The application consists of general
The Department specifically requests Administration for Children and information and instructions; the
comments on: (a) Whether the proposed Families Standard Form 424 series, which
collection of information is necessary requests basic information, budget
for the proper performance of the Submission for OMB Review; information, and assurances; the Project
functions of the agency, including Comment Request Description that requests the applicant
whether the information shall have to describe how program objectives will
practical utility; (b) the accuracy of the Title: Uniform Project Description be achieved; and other assurances and
agency’s estimate of the burden of the (UPD) Program Narrative Format for certifications. Guidance for the content
proposed collection of information; (c) Discretionary Grant Application Forms. of information requested in the Uniform
the quality, utility, and clarity of the OMB No.: 0970–0139. Project Description is based in 45 CFR
information to be collected; and (d) Description: The proposed 75.203, 75.204, and 45 CFR part 75,
ways to minimize the burden of the information collection would renew the Appendix I.
collection of information on Administration for Children and Respondents: Applicants to ACF
respondents, including through the use Families (ACF) Uniform Project Discretionary Funding Opportunity
of automated collection techniques or Description (UPD). The UPD provides a Announcements.

ANNUAL BURDEN ESTIMATES
Number of Average
Number of responses Total burden
Instrument burden hours
respondents per hours
per response
respondent

ACF Uniform Project Description (UPD) ......................................................... 4,562 1 60 273,720

Estimated Total Annual Burden Desk Officer for the Administration for ‘‘Selection of the Appropriate Package
Hours: 273,720. Children and Families. Type Terms and Recommendations for
Additional Information: Copies of the Labeling Injectable Medical Products
Robert Sargis,
proposed collection may be obtained by Packaged in Multiple-Dose, Single-Dose,
Reports Clearance Officer. and Single-Patient-Use Containers for
writing to the Administration for [FR Doc. 2015–26841 Filed 10–21–15; 8:45 am] Human Use.’’ This guidance has been
Children and Families, Office of BILLING CODE 4184–01–P developed to provide industry with
Planning, Research and Evaluation, 370 FDA’s recommendations on the
L’Enfant Promenade, SW., Washington, selection of appropriate package type
DC 20447, Attn: ACF Reports Clearance DEPARTMENT OF HEALTH AND terms and selection of appropriate
Officer. All requests should be HUMAN SERVICES discard statements for injectable
identified by the title of the information medical products for human use,
collection. Email address: Food and Drug Administration
packaged in multiple-dose, single-dose,
infocollection@acf.hhs.gov. [Docket No. FDA–2015–D–3438] and single-patient-use containers. This
OMB Comment: OMB is required to guidance provides FDA’s revised
Selection of the Appropriate Package definitions for single-dose and multiple-
make a decision concerning the
Type Terms and Recommendations for dose containers, and introduces the
collection of information between 30
Labeling Injectable Medical Products definition of a new package type term,
and 60 days after publication of this
Packaged in Multiple-Dose, Single- ‘‘single-patient-use’’ container.
document in the Federal Register. Dose, and Single-Patient-Use
Therefore, a comment is best assured of Marketing applications for such
Containers for Human Use; Draft products include: New Drug
having its full effect if OMB receives it Guidance for Industry; Availability
within 30 days of publication. Written Applications (NDAs), Abbreviated New
AGENCY: Food and Drug Administration, Drug Applications (ANDAs), Biologics
comments and recommendations for the
tkelley on DSK3SPTVN1PROD with NOTICES

HHS. License Applications (BLAs), Premarket
proposed information collection should
ACTION: Notice. Approval Applications (PMAs), and
be sent directly to the following: Office
Premarket Notifications under section
of Management and Budget, Paperwork 510(k) of the Federal Food, Drug, and
SUMMARY: The Food and Drug
Reduction Project, Email: OIRA_ Cosmetic Act (FD&C Act).
Administration (FDA or Agency) is
SUBMISSION@OMB.EOP.GOV, Attn:
announcing the availability of a draft DATES: Although you can comment on
guidance for industry entitled any guidance at any time (see 21 CFR

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Federal Register / Vol. 80, No. 204 / Thursday, October 22, 2015 / Notices 64007

This draft guidance is being issued Dated: October 16, 2015. Agenda: To review and evaluate grant
consistent with FDA’s good guidance Leslie Kux, applications.
practices regulation (21 CFR 10.115). Associate Commissioner for Policy. Place: National Institutes of Health, 6701
The draft guidance, when finalized, will Rockledge Drive, Bethesda, MD 20892,
[FR Doc. 2015–26849 Filed 10–21–15; 8:45 am] (Virtual Meeting).
represent the current thinking of FDA BILLING CODE 4164–01–P Contact Person: Mehrdad Mohseni, MD,
on ‘‘Selection of the Appropriate Scientific Review Officer, Center for
Package Type Terms and Scientific Review, National Institutes of
Recommendations for Labeling DEPARTMENT OF HEALTH AND Health, 6701 Rockledge Drive, Room 5211,
Injectable Medical Products Packaged in HUMAN SERVICES MSC 7854, Bethesda, MD 20892, 301–435–
Multiple-Dose, Single-Dose, and Single- 0484, mohsenim@csr.nih.gov.
Patient-Use Containers for Human Use.’’ National Institutes of Health Name of Committee: Center for Scientific
It does not establish any rights for any Review Special Emphasis Panel; AREA grant
person and is not binding on FDA or the Center for Scientific Review; Notice of applications: Toxicology and Digestive,
public. You can use an alternative Closed Meetings Kidney and Urological Systems.
approach if it satisfies the requirements Date: November 17, 2015.
Pursuant to section 10(d) of the Time: 11:30 a.m. to 2:00 p.m.
of the applicable statutes and
Federal Advisory Committee Act, as Agenda: To review and evaluate grant
regulations.
amended (5 U.S.C. App.), notice is applications.
II. Electronic Access hereby given of the following meetings. Place: National Institutes of Health, 6701
Persons with access to the Internet The meetings will be closed to the Rockledge Drive, Bethesda, MD 20892,
public in accordance with the (Telephone Conference Call).
may obtain the draft guidance at either
provisions set forth in sections Contact Person: Patricia Greenwel, Ph.D.,
http://www.fda.gov/Drugs/ Scientific Review Officer, Center for
GuidanceComplianceRegulatory 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Scientific Review, National Institutes of
Information/Guidances/default.htm or as amended. The grant applications and Health, 6701 Rockledge Drive, Room 2178,
http://www.regulations.gov. the discussions could disclose MSC 7818, Bethesda, MD 20892, 301–435–
confidential trade secrets or commercial 1169, greenwep@csr.nih.gov.
III. The Paperwork Reduction Act of property such as patentable material,
1995 Name of Committee: Center for Scientific
and personal information concerning Review Special Emphasis Panel; Small
This guidance refers to previously individuals associated with the grant Business: Skeletal Muscle.
approved collections of information that applications, the disclosure of which Date: November 17, 2015.
are subject to review by the Office of would constitute a clearly unwarranted Time: 1:00 p.m. to 4:00 p.m.
Management and Budget (OMB) under invasion of personal privacy. Agenda: To review and evaluate grant
the Paperwork Reduction Act of 1995 applications.
Name of Committee: Center for Scientific
(44 U.S.C. 3501–3520). The collections Place: National Institutes of Health, 6701
Review Special Emphasis Panel; Program
of information discussed in this draft Rockledge Drive, Bethesda, MD 20892,
Project: Molecular structure, dynamics, and
guidance have been approved under (Telephone Conference Call).
mechanism of key membrane transporters
Contact Person: Richard Ingraham, Ph.D.,
OMB under the following control and enzymes in cellular metabolism.
Scientific Review Officer, Center for
numbers: OMB control number 0910– Date: November 17–18, 2015.
Scientific Review, National Institutes of
0001 for NDAs, ANDAs, supplements to Time: 7:00 a.m. to 5:00 p.m.
Health, 6701 Rockledge Drive, Room 4116,
NDAs and ANDAs, and annual reports; Agenda: To review and evaluate grant
applications. MSC 7814, Bethesda, MD 20892, 301–496–
OMB control number 0910–0572 for 8551, ingrahamrh@mail.nih.gov.
Place: National Institutes of Health, 6701
prescription drug product labeling; Name of Committee: Center for Scientific
Rockledge Drive, Bethesda, MD 20892,
OMB control number 0910–0338 for (Virtual Meeting). Review Special Emphasis Panel; Program
BLA, BLA supplements and annual Contact Person: Kathryn M. Koeller, Ph.D., Projects: New Modalities for the Treatment of
reports; OMB control number 0910– Scientific Review Officer, Center for Pain and Drug Abuse.
0120 for premarket notifications Scientific Review, National Institutes of Date: November 17, 2015.
(510(k)s); OMB control number 0910– Health, 6701 Rockledge Drive, Room 4166, Time: 1:00 p.m. to 4:00 p.m.
0231 for premarket approval MSC 7806, Bethesda, MD 20892, 301–435– Agenda: To review and evaluate grant
applications (PMAs); OMB control 2681, koellerk@csr.nih.gov. applications.
Name of Committee: Center for Scientific Place: National Institutes of Health, 6701
number 0910–0485 for medical device
Review Special Emphasis Panel; PAR13–189: Rockledge Drive, Bethesda, MD 20892,
labeling; and OMB control number (Telephone Conference Call).
0910–0577 for prominent and Imaging and Biomarkers for Early Cancer
Detection. Contact Person: Geoffrey G. Schofield,
conspicuous mark of manufacturers on Ph.D., Scientific Review Officer, Center for
Date: November 17, 2015.
single-use devices. Relevant to this Time: 10:00 a.m. to 2:00 p.m. Scientific Review, National Institutes of
collection of information, FDA Agenda: To review and evaluate grant Health, 6701 Rockledge Drive, Room 4040–A,
published its proposed rule on the applications. MSC 7850, Bethesda, MD 20892, 301–435–
electronic distribution of prescribing Place: National Institutes of Health, 6701 1235, geoffreys@csr.nih.gov.
information for human prescription Rockledge Drive, Bethesda, MD 20892, (Catalogue of Federal Domestic Assistance
drugs, including biological products in (Virtual Meeting). Program Nos. 93.306, Comparative Medicine;
the Federal Register of December 18, Contact Person: Chiayeng Wang, Ph.D., 93.333, Clinical Research, 93.306, 93.333,
Scientific Review Officer. Center for 93.337, 93.393–93.396, 93.837–93.844,
2014 (79 FR 75506). In Section VII,
Scientific Review. 6701 Rockledge Drive, 93.846-93.878, 93.892, 93.893, National
‘‘Paperwork Reduction Act of 1995,’’ Institutes of Health, HHS).
Room 5213, MSC 7852, Bethesda, MD 20892,
tkelley on DSK3SPTVN1PROD with NOTICES

FDA estimated the burden to design, 301–435–2397, chiayeng.wang@nih.gov.
test, and produce the label for a drug Dated: October 16, 2015.
Name of Committee: Center for Scientific Anna Snouffer,
product’s immediate container and Review Special Emphasis Panel; PAR–14–
outer container or package, as set forth Deputy Director, Office of Federal Advisory
092: Bioengineering Research Partnerships
in 21 CFR part 201, including Committee Policy.
(BRP).
§ 201.100(b) and other sections in Date: November 17, 2015. [FR Doc. 2015–26774 Filed 10–21–15; 8:45 am]
subpart A and subpart B. Time: 11:00 a.m. to 5:00 p.m. BILLING CODE 4140–01–P

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Document Created: 2015-12-14 15:34:15
Document Modified: 2015-12-14 15:34:15

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
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 December 21, 2015.
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.
FR Citation		80 FR 64005

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 SERVICESFood and Drug Administration

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration