80 FR 36547 - Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 122 (June 25, 2015)

Page Range		36547-36548
FR Document		2015-15637

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products.'' It replaces the draft of the same name that was published on March 14, 2014. This guidance clarifies FDA requirements and regulations pertaining to allowable excess volume in injectable vials and reinforces the importance of appropriate fill volumes and labeled vial fill sizes for injectable drug and biological products.

Federal Register, Volume 80 Issue 122 (Thursday, June 25, 2015)

[Federal Register Volume 80, Number 122 (Thursday, June 25, 2015)]
[Notices]
[Pages 36547-36548]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-15637]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0248]

Allowable Excess Volume and Labeled Vial Fill Size in Injectable
Drug and Biological Products; Guidance for Industry; 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 guidance for industry entitled ``Allowable Excess
Volume and Labeled Vial Fill Size in Injectable Drug and Biological
Products.'' It replaces the draft of the same name that was published
on March 14, 2014. This guidance clarifies FDA requirements and
regulations pertaining to allowable excess volume in injectable vials
and reinforces the importance of appropriate fill volumes and labeled
vial fill sizes for injectable drug and biological products.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: 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 Center
for Biologics Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-
0002, 240-402-7911. Send one self-addressed adhesive label to assist
that office in processing your requests. The guidance may also be
obtained by mail by calling CBER at 1-800-835-4709 or 240-402-7800. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Pallavi Nithyanandan, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD

[[Page 36548]]

20993-0002, 301-796-7546; or Stephen Ripley, Center for Biologics
Evaluation and Research, Food and Drug Administration, 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 ``Allowable Excess Volume and Labeled Vial Fill Size in
Injectable Drug and Biological Products.'' This guidance replaces the
draft guidance of the same name that published in the Federal Register
of March 14, 2014 (79 FR 14517). FDA is concerned that injectable vial
misuse, including unsafe handling and injection techniques, has led to
an increase in vial contamination and an increased risk of bloodborne
illness transmission between patients. This guidance clarifies the FDA
requirements and regulations pertaining to allowable excess volume in
injectable vials and describes when justification is needed for a
proposed excess volume in an injectable drug or biological product.
This guidance also discusses the importance of appropriate fill volume
and recommends that labeled vial fill sizes be appropriate for the use
and dosing of the drug and biological product.
In the Federal Register of March 14, 2014 (79 FR 14517), a draft
guidance was published entitled ``Draft Guidance for Industry on
Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug
and Biological Products; Availability.'' We have carefully reviewed and
considered the comments that were received on the draft guidance and
have made changes for clarification.
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 allowable excess fill volume and labeled
vial fill size for injectable drug and biological products packaged in
vials and ampules. 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. 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 in 21 CFR parts 312 and 314 have
been approved under OMB control numbers 0910-0014 and 0910-0001,
respectively.

III. Comments

Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

Persons with access to the Internet may obtain the document at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

Dated: June 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-15637 Filed 6-24-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 122 / Thursday, June 25, 2015 / Notices 36547

FDA estimates the burden of this
collection of information as follows:

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Completes ...................... 640 1 640 1 ....................................................... 640

Main Study

Number to Complete the Screener 2,112 1 2,112 0.08 (5 minutes) .............................. 169
(Assumes 50% Eligible).
Number of Completes ...................... 1,056 1 1,056 1 ....................................................... 1,056

Total .......................................... ........................ ........................ ........................ .......................................................... 1,967.40
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The following references have been Structure, and Processing Time, The Journals ACTION: Notice.
placed on display in the Division of of Gerontology, 1985;40(5):579–85.
Dockets Management (see ADDRESSES) 11. Kramer AF, Hahn S, Gopher D. Task SUMMARY: The Food and Drug
Coordination and Aging: Explorations of Administration (FDA) is announcing the
and may be seen by interested persons
Executive Control Processes in the Task availability of a guidance for industry
between 9 a.m. and 4 p.m., Monday Switching Paradigm, Acta Psychologica,
through Friday, and are available entitled ‘‘Allowable Excess Volume and
1999;101:339–78.
electronically at http:// Labeled Vial Fill Size in Injectable Drug
12. Naveh-Benjamin M, Guez J, Kilb A,
www.regulations.gov. Reedy S. The Associative Memory Deficit of and Biological Products.’’ It replaces the
Older Adults: Further Support Using Face- draft of the same name that was
References Name Associations, Psychology and Aging, published on March 14, 2014. This
1. Zhong W, Maradit-Kremers H, St. Sauver 2004;19(3):541–6. guidance clarifies FDA requirements
JL, Yawn BP, Ebbert JO, Roger VL, Jacobson 13. Sommers MS, Tye-Murray N, Spehar B, and regulations pertaining to allowable
DJ, McGree ME, Brue SM, Rocca WA, Age Auditory-Visual Speech Perception and excess volume in injectable vials and
and Sex Patterns of Drug Prescribing in a Auditory-Visual Enhancement in Normal- reinforces the importance of appropriate
Defined American Population, Mayo Clinc Hearing Younger and Older Adults, Ear and
fill volumes and labeled vial fill sizes
Proceedings, 2013;88(7):697–707. Hearing, 2005;26(3):263–75.
14. Watson JM, McDermott KB, Balota DA, for injectable drug and biological
2. Depp CA, Schkade DA, Thompson WK,
Jeste DV, Age, Affective Experience, and Attempting to Avoid False Memories in the products.
Television Use, American Journal of Deese/Roediger-McDermott Paradigm: DATES: Submit either electronic or
Preventative Medicine, 2010;39:173–8. Assessing the Combined Influence of Practice written comments on Agency guidances
3. Agrawal Y, Platz EA, Niparko JK, and Warnings in Young and Old Adults,
at any time.
Prevalence of Hearing Loss and Differences Memory and Cognition, 2004;32(1):135–41.
15. Gates GA, Feeney MP, Mills D, Cross- ADDRESSES: Submit written requests for
by Demographic Characteristics Among US
Adults, Archives of Internal Medicine, Sectional Age-Changes of Hearing in the single copies of this guidance to the
2008;168(14):1522–30. Elderly, Ear and Hearing, 2008;29(6):865–74. Division of Drug Information, Center for
4. Cruickshanks KJ, Wiley TL, Tweed TS, 16. Morrell CH, Gordon-Salant S, Pearson Drug Evaluation and Research, Food
Klein BEK, Klein R, Mares-Perlman JA, JD, Brant LJ, Fozard JL, Age- and Gender- and Drug Administration, 10001 New
Nondahl DM, Prevalence of Hearing Loss in Specific Reference Ranges for Hearing Level Hampshire Ave., Hillandale Building,
Older Adults in Beaver Dam, Wisconsin, and Longitudinal Changes in Hearing Level,
4th Floor, Silver Spring, MD 20993–
American Journal of Epidemiology. Journal of the Acoustical Society of America,
1996;100(4)Pt. 1:1949–67. 0002; or Center for Biologics Evaluation
1998;148(9):879–86. and Research, Food and Drug
5. Lin FR, Thorpe R, Gordon-Salant S, 17. Cutler A, Dahan D, van Donselaar W.,
Prosody in the Comprehension of Spoken Administration, 10903 New Hampshire
Ferrucci L. Hearing Loss Prevalence and Risk
Factors Among Older Adults in the United Language: A Literature Review, Language Ave., Bldg. 71, Rm. 7301, Silver Spring,
States, The Journals of Gerontology Series A: and Speech, 1997;40(2):141–201. MD 20993–0002, 240–402–7911. Send
Biological Sciences and Medical Sciences, Dated: June 18, 2015. one self-addressed adhesive label to
2011;66A(5):582–90. Leslie Kux, assist that office in processing your
6. Garstecki DC, Erler SF. Hearing Loss, requests. The guidance may also be
Associate Commissioner for Policy.
Control, and Demographic Factors obtained by mail by calling CBER at 1–
Influencing Hearing Aid Use Among Older [FR Doc. 2015–15557 Filed 6–24–15; 8:45 am]
800–835–4709 or 240–402–7800. See
Adults, Journal of Speech, Language, and BILLING CODE 4164–01–P
the SUPPLEMENTARY INFORMATION section
Hearing Research, 1998;41:527–37.
for electronic access to the guidance
7. Gates GA, Cooper JC. Incidence of
Hearing Decline in the Elderly, Acta Oto- document.
DEPARTMENT OF HEALTH AND Submit electronic comments on the
laryngol, 1991;111:240–8. HUMAN SERVICES
8. Humes LE, Speech Understanding in the guidance to http://www.regulations.gov.
Elderly, Journal of the American Academy of Food and Drug Administration Submit written comments to the
Audiology, 1996; 7:161–7. Division of Dockets Management (HFA–
asabaliauskas on DSK5VPTVN1PROD with NOTICES

9. U.S. Food and Drug Administration. [Docket No. FDA–2014–D–0248] 305), Food and Drug Administration,
Code of Federal Regulations, Prescription 5630 Fishers Lane, Rm. 1061, Rockville,
Drug Advertisements, 21 CFR Sect. 202.1. Allowable Excess Volume and Labeled MD 20852.
2013. Retrieved from: http:// Vial Fill Size in Injectable Drug and
FOR FURTHER INFORMATION CONTACT:
www.accessdata.fda.gov/scripts/cdrh/cfdocs/ Biological Products; Guidance for
cfCFR/CFRSearch.cfm?fr=202.1 Pallavi Nithyanandan, Center for Drug
Industry; Availability
10. Wingfield A, Poon LW, Lombardi L, Evaluation and Research, Food and
Lowe D. Speed of Processing in Normal AGENCY: Food and Drug Administration, Drug Administration, 10903 New
Aging: Effects of Speech Rate, Linguistic HHS. Hampshire Ave., Silver Spring, MD

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36548 Federal Register / Vol. 80, No. 122 / Thursday, June 25, 2015 / Notices

20993–0002, 301–796–7546; or Stephen control numbers 0910–0014 and 0910– competence of individual investigators,
Ripley, Center for Biologics Evaluation 0001, respectively. the disclosure of which would
and Research, Food and Drug constitute a clearly unwarranted
III. Comments
Administration, 10903 New Hampshire invasion of personal privacy.
Ave., Bldg. 71, Rm. 7301, Silver Spring, Interested persons may submit either
Name of Committee: Board of Scientific
MD 20993–0002, 240–402–7911. electronic comments regarding this Counselors, National Center for
SUPPLEMENTARY INFORMATION:
document to http://www.regulations.gov Biotechnology Information.
or written comments to the Division of Date: December 1, 2015.
I. Background Dockets Management (see ADDRESSES). It Open: 8:30 a.m. to 12:00 p.m.
is only necessary to send one set of Agenda: Program Discussion.
FDA is announcing the availability of Place: National Library of Medicine,
a guidance for industry entitled comments. Identify comments with the
docket number found in brackets in the Building 38, 2nd Floor, The Lindberg Room,
‘‘Allowable Excess Volume and Labeled 8600 Rockville Pike, Bethesda, MD 20892.
Vial Fill Size in Injectable Drug and heading of this document. Received
Closed: 12:00 p.m. to 2:00 p.m.
Biological Products.’’ This guidance comments may be seen in the Division Agenda: To review and evaluate personal
replaces the draft guidance of the same of Dockets Management between 9 a.m. qualifications and performance, and
name that published in the Federal and 4 p.m., Monday through Friday, and competence of individual investigators.
Register of March 14, 2014 (79 FR will be posted to the docket at http:// Place: National Library of Medicine,
www.regulations.gov. Building 38, 2nd Floor, The Lindberg Room,
14517). FDA is concerned that injectable
8600 Rockville Pike, Bethesda, MD 20892.
vial misuse, including unsafe handling IV. Electronic Access Open: 2:00 p.m. to 3:00 p.m.
and injection techniques, has led to an Agenda: Program Discussion.
Persons with access to the Internet
increase in vial contamination and an Place: National Library of Medicine,
may obtain the document at http://
increased risk of bloodborne illness Building 38, 2nd Floor, The Lindberg Room,
www.fda.gov/Drugs/Guidance 8600 Rockville Pike, Bethesda, MD 20892.
transmission between patients. This
ComplianceRegulatoryInformation/ Contact Person: David J. Lipman, MD,
guidance clarifies the FDA requirements
Guidances/default.htm, http:// Director, National Center of Biotechnology
and regulations pertaining to allowable
www.fda.gov/BiologicsBloodVaccines/ Information, National Library of Medicine,
excess volume in injectable vials and
GuidanceComplianceRegulatory Department of Health and Human Services,
describes when justification is needed Building 38A, Room 8N805, Bethesda, MD
Information/default.htm, or http://
for a proposed excess volume in an 20892, 301–435–5985, dlipman@
www.regulations.gov.
injectable drug or biological product. mail.nih.gov.
This guidance also discusses the Dated: June 22, 2015.
Any interested person may file written
importance of appropriate fill volume Leslie Kux, comments with the committee by forwarding
and recommends that labeled vial fill Associate Commissioner for Policy. the statement to the Contact Person listed on
sizes be appropriate for the use and [FR Doc. 2015–15637 Filed 6–24–15; 8:45 am] this notice. The statement should include the
dosing of the drug and biological BILLING CODE 4164–01–P
name, address, telephone number and when
product. applicable, the business or professional
In the Federal Register of March 14, affiliation of the interested person.
In the interest of security, NIH has
2014 (79 FR 14517), a draft guidance DEPARTMENT OF HEALTH AND
instituted stringent procedures for entrance
was published entitled ‘‘Draft Guidance HUMAN SERVICES onto the NIH campus. All visitor vehicles,
for Industry on Allowable Excess including taxicabs, hotel, and airport shuttles
Volume and Labeled Vial Fill Size in National Institutes of Health will be inspected before being allowed on
Injectable Drug and Biological Products; campus. Visitors will be asked to show one
Availability.’’ We have carefully National Library of Medicine; Notice of form of identification (for example, a
reviewed and considered the comments Meeting government-issued photo ID, driver’s license,
that were received on the draft guidance Pursuant to section 10(a) of the or passport) and to state the purpose of their
and have made changes for clarification. visit.
Federal Advisory Committee Act, as
This guidance is being issued amended (5 U.S.C. App), notice is (Catalogue of Federal Domestic Assistance
Program No. 93.879, Medical Library
consistent with FDA’s good guidance hereby given of a meeting of the Board Assistance, National Institutes of Health,
practices regulation (21 CFR 10.115). of Scientific Counselors, National HHS).
The guidance represents the current Center for Biotechnology Information.
thinking of FDA on allowable excess fill The meeting will be open to the Dated: June 19, 2015.
volume and labeled vial fill size for public as indicated below, with Michelle Trout,
injectable drug and biological products attendance limited to space available. Program Analyst, Office of Federal Advisory
packaged in vials and ampules. It does Individuals who plan to attend and Committee Policy.
not establish any rights for any person need special assistance, such as sign [FR Doc. 2015–15602 Filed 6–24–15; 8:45 am]
and is not binding on FDA or the public. language interpretation or other BILLING CODE 4140–01–P
You can use an alternative approach if reasonable accommodations, should
it satisfies the requirements of the notify the Contact Person listed below
applicable statutes and regulations. in advance of the meeting. DEPARTMENT OF HEALTH AND
The meeting will be closed to the HUMAN SERVICES
II. Paperwork Reduction Act of 1995 public as indicated below in accordance
asabaliauskas on DSK5VPTVN1PROD with NOTICES

This guidance refers to previously with the provisions set forth in section National Institutes of Health
approved collections of information that 552b(c)(6), Title 5 U.S.C., as amended
National Institute of Mental Health;
are subject to review by the Office of for review, discussion, and evaluation of
Notice of Closed Meetings
Management and Budget (OMB) under individual intramural programs and
the Paperwork Reduction Act of 1995 projects conducted by the NATIONAL Pursuant to section 10(d) of the
(44 U.S.C. 3501–3520). The collections LIBRARY OF MEDICINE, including Federal Advisory Committee Act, as
of information in 21 CFR parts 312 and consideration of personnel amended (5 U.S.C. App.), notice is
314 have been approved under OMB qualifications and performance, and the hereby given of the following meetings.

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Document Created: 2015-12-15 14:16:43
Document Modified: 2015-12-15 14:16:43

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		Submit either electronic or written comments on Agency guidances at any time.
Contact		Pallavi Nithyanandan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-7546; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240- 402-7911.
FR Citation		80 FR 36547

80 FR 36547 - Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 122 (June 25, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration