83 FR 25018 - Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management; International Council for Harmonisation; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 105 (May 31, 2018)

Page Range		25018-25020
FR Document		2018-11641

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance entitled ``Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management; International Council for Harmonisation.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance, which consists of a Core Guideline and an Annex, provides a framework to facilitate the management of post-approval chemistry, manufacturing, and controls changes for new and marketed pharmaceutical drug substances and drug products, including marketed chemical and biotechnological/biological products.

Federal Register, Volume 83 Issue 105 (Thursday, May 31, 2018)

[Federal Register Volume 83, Number 105 (Thursday, May 31, 2018)]
[Notices]
[Pages 25018-25020]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-11641]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1609]

Q12 Technical and Regulatory Considerations for Pharmaceutical
Product Lifecycle Management; International Council for Harmonisation;
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance entitled ``Q12 Technical and Regulatory
Considerations for Pharmaceutical Product Lifecycle Management;
International Council for Harmonisation.'' The draft guidance was
prepared under the auspices of the International Council for
Harmonisation (ICH), formerly the International Conference on
Harmonisation. The draft guidance, which consists of a Core Guideline
and an Annex, provides a framework to facilitate the management of
post-approval chemistry, manufacturing, and controls changes for new
and marketed pharmaceutical drug substances and drug products,
including marketed chemical and biotechnological/biological products.

DATES: Submit either electronic or written comments on the draft
guidance by December 15, 2018, to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-

[[Page 25019]]

2018-D-1609 for ``Q12 Technical and Regulatory Considerations for
Pharmaceutical Product Lifecycle Management; Draft Guidance for
Industry; Availability.'' 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 office 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 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 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 that office in processing
your requests. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Mahesh
Ramanadham, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-3272; or Ingrid Markovic, Center for Biologics Evaluation and
Research (HFM-17), Food and Drug Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993-0002, 240-402-8115.
Regarding the ICH: Amanda Roache, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 1176, Silver Spring, MD 20993-0002, 301-796-4548.

SUPPLEMENTARY INFORMATION:

I. Background

In recent years, regulatory authorities and industry associations
from around the world have participated in many important initiatives
to promote international harmonization of regulatory requirements under
the ICH. FDA has participated in several ICH meetings designed to
enhance harmonization and FDA is committed to seeking scientifically
based harmonized technical procedures for pharmaceutical development.
One of the goals of harmonization is to identify and reduce differences
in technical requirements for drug development among regulatory
Agencies.
ICH was established to provide an opportunity for harmonization
initiatives to be developed with input from both regulatory and
industry representatives. FDA also seeks input from consumer
representatives and others. ICH is concerned with harmonization of
technical requirements for the registration of pharmaceutical products
for human use among regulators around the world. The six founding
members of the ICH are the European Commission; the European Federation
of Pharmaceutical Industries Associations; the FDA; the Japanese
Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical
Manufacturers Association; and the Pharmaceutical Research and
Manufacturers of America. The Standing Members of the ICH Association
include Health Canada and Swissmedic. Any party eligible as a Member in
accordance with the ICH Articles of Association can apply for
membership in writing to the ICH Secretariat. The ICH Secretariat,
which coordinates the preparation of documentation, operates as an
international nonprofit organization and is funded by the Members of
the ICH Association.
The ICH Assembly is the overarching body of the Association and
includes representatives from each of the ICH members and observers.
The Assembly is responsible for the endorsement of draft guidelines and
adoption of final guidelines. FDA publishes ICH guidelines as FDA
guidance.
In November 2017, the ICH Assembly endorsed the draft guidance
entitled ``Q12 Technical and Regulatory Considerations for
Pharmaceutical Product Lifecycle Management'' and agreed that the
guidance should be made available for public comment. The draft
guidance is the product of the Q12 Expert Working Group of the ICH.
Comments about this draft will be considered by FDA and the Q12 Expert
Working Group.
The guidance provides guidance on post-approval chemistry,
manufacturing, and controls changes for new and marketed pharmaceutical
drug substances and drug products. The guidance describes regulatory
tools and enablers, along with associated guiding principles, that are
intended to enhance the management of post-approval changes and
transparency between industry and regulatory authorities, encouraging
innovation and continual improvement. The guidance is intended to
demonstrate how increased product and process knowledge can contribute
to a reduction in the number of regulatory submissions needed for such
post-approval changes. Specifically, effective implementation of the
tools and enablers described in the guideline should enhance industry's
ability to manage many postapproval changes effectively under the
firm's Pharmaceutical Quality System with less need for extensive
regulatory oversight prior to implementation. The extent of operational
and regulatory flexibility is subject to product and process
understanding (ICH Q8 and Q11), application of risk management
principles (ICH Q9), and an effective pharmaceutical quality system
(ICH Q10).

[[Page 25020]]

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 ``Q12
Technical and Regulatory Considerations for Pharmaceutical Product
Lifecycle Management.'' 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. Electronic Access

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

Dated: May 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-11641 Filed 5-30-18; 8:45 am]
BILLING CODE 4164-01-P

25020 Federal Register / Vol. 83, No. 105 / Thursday, May 31, 2018 / Notices

This draft guidance is being issued among the various federal agencies This report provided recommendations
consistent with FDA’s good guidance involved in vaccine and immunization to the ASH on how to increase Human
practices regulation (21 CFR 10.115). activities. The NVPO also supports the Papillomavirus (HPV) vaccine uptake in
The draft guidance, when finalized, will National Vaccine Advisory Committee young adolescents by reviewing the
represent the current thinking of FDA (NVAC). The NVAC advises and makes current state of HPV immunization,
on ‘‘Q12 Technical and Regulatory recommendations to the ASH in his understanding the root cause(s) for the
Considerations for Pharmaceutical capacity as the Director of the National observed relatively low vaccine uptake
Product Lifecycle Management.’’ It does Vaccine Program on matters related to (both initiation and series completion),
not establish any rights for any person vaccine program responsibilities. and identifying existing best practices.
and is not binding on FDA or the public. The ASH charged the NVAC in Since the original NVAC HPV report,
You can use an alternative approach if February 2018 to establish a work group substantial progress led to policy and
it satisfies the requirements of the to produce a brief report by June 2018 program changes and advances in
applicable statutes and regulations. This on recommendations to strengthen the research. To build on the substantial
guidance is not subject to Executive effectiveness of national, state, and local progress made toward increasing HPV
Order 12866. efforts to improve Human vaccination coverage rates, the ASH
Papillomavirus (HPV) coverage rates. charged the NVAC in February 2018 to
II. Electronic Access
Through a series of conference calls, establish a work group to produce a
Persons with access to the internet electronic communication, and public brief report by June 2018 on
may obtain the document at https:// discussion at the May 3, 2018, NVAC recommendations to ‘‘strengthen the
www.regulations.gov, https:// public meeting, the work group effectiveness of national, state, and local
www.fda.gov/Drugs/Guidance identified a number of draft efforts to improve HPV coverage rates.’’
ComplianceRegulatoryInformation/ recommendations for consideration by The ASH specifically requested the
Guidances/default.htm, or https:// the NVAC. The work group’s draft NVAC to consider the following:
www.fda.gov/BiologicsBloodVaccines/ report and recommendations will (1) Many national organizations are
GuidanceComplianceRegulatory inform NVAC deliberations as it currently supporting HPV efforts. Are
Information/Guidances/default.htm. finalizes recommendations for there additional national organizations
Dated: May 24, 2018. transmittal to the ASH. that might contribute to increasing HPV
Leslie Kux, On behalf of NVAC, NVPO is vaccination coverage?
Associate Commissioner for Policy. soliciting public comment on the draft (2) At the state level, many states have
report and draft recommendations from formed coalitions to support HPV
[FR Doc. 2018–11641 Filed 5–30–18; 8:45 am]
a variety of stakeholders, including the vaccination efforts. Is there general
BILLING CODE 4164–01–P
general public, for consideration by the guidance for states that do not yet have
NVAC as they develop their final coalitions?
recommendations to the ASH. It is (3) Integrated health care delivery
DEPARTMENT OF HEALTH AND
anticipated that the draft report and networks can successfully integrate
HUMAN SERVICES
draft recommendations, as revised with comprehensive quality improvement
Solicitation of Written Comments on consideration given to public comment approaches to increase vaccination
the Human Papillomavirus Vaccination and stakeholder input, will be presented coverage rates. How can state
Implementation Work Group Draft to the NVAC for adoption in June 2018 immunization programs and coalitions
Report and Draft Recommendations at the quarterly NVAC meeting. engage with health systems to work
for Consideration by the National DATES: Comments for consideration by
together on improving HPV vaccination
Vaccine Advisory Committee the NVAC should be received no later coverage?
(4) Please specify recommendations
AGENCY: National Vaccine Program than 5:00 p.m. EDT on June 15, 2018.
on how to meet the needs of providers
Office, Office of the Assistant Secretary ADDRESSES:
in rural areas.
for Health, Office of the Secretary, (1) The draft report and draft The NVAC established the Human
Department of Health and Human recommendations are available on the Papillomavirus Vaccination
Services. web at http://www.hhs.gov/nvpo/nvac/ Implementation Work Group in
index.html. February 2018, a work group tasked to
ACTION: Notice.
(2) Electronic responses may be sent engage with a wide-range of
SUMMARY: The National Vaccine to: nvac@hhs.gov. implementation partners from across all
Advisory Committee (NVAC) was FOR FURTHER INFORMATION CONTACT: sectors (e.g., government, industry,
established in 1987 to comply with Title Captain Angela Shen, Designated health systems, associations, academia,
XXI of the Public Health Service Act. Its Federal Officer, National Vaccine and non-profit) to inform NVAC’s work
purpose is to advise and make Program Office, U.S. Department of and these recommendations.
recommendations to the Director of the Health and Human Services, Room The NVAC draft report highlights the
National Vaccine Program on matters 715H, Hubert H. Humphrey Building, progress made toward increasing HPV
related to program responsibilities. The 200 Independence Avenue SW, vaccination coverage rates, since the
Assistant Secretary for Health (ASH) has Washington, DC 20201. Phone: 202– 2015 NVAC report. The
been designated by the Secretary of 690–5566; email nvac@hhs.gov. recommendations detail how the ASH
Health and Human Services (HHS) as SUPPLEMENTARY INFORMATION: can support HHS activities to strengthen
the Director of the National Vaccine the effectiveness of national, state, and
amozie on DSK3GDR082PROD with NOTICES1

Program. The National Vaccine Program I. Background
local efforts to improve HPV coverage
Office (NVPO) is located within the On June 9, 2015, the National Vaccine rates.
Office of the Assistant Secretary for Advisory Committee (NVAC) issued a
Health (OASH), Office of the Secretary, report ‘‘Overcoming Barriers to Low II. Request for Comment
U.S. Department of Health and Human HPV Vaccine Uptake in the United NVPO, on behalf of the NVAC HPV
Services (HHS). NVPO provides States: Recommendations from the Vaccination Implementation Work
leadership and fosters collaboration National Vaccine Advisory Committee.’’ Group, requests input on the draft report

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Document Created: 2018-05-31 00:48:27
Document Modified: 2018-05-31 00:48:27

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 of availability.
Dates		Submit either electronic or written comments on the draft guidance by December 15, 2018, to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
Contact		Regarding the guidance: Mahesh Ramanadham, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3272; or Ingrid Markovic, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-8115.
FR Citation		83 FR 25018

83 FR 25018 - Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management; International Council for Harmonisation; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 105 (May 31, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration