[Federal Register Volume 80, Number 246 (Wednesday, December 23, 2015)]
[Notices]
[Pages 79907-79908]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32316]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-4644]


Draft Guidance for Industry on Advancement of Emerging Technology 
Applications To Modernize the Pharmaceutical Manufacturing Base; Draft 
Guidance for Industry; Availability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the availability of a draft guidance for industry entitled 
``Advancement of Emerging Technology Applications to Modernize the 
Pharmaceutical Manufacturing Base.'' This guidance provides 
recommendations to pharmaceutical companies interested in participating 
in a program involving the submission of chemistry, manufacturing, and 
controls (CMC) information containing emerging manufacturing 
technology. The program is open to companies that intend the technology 
to be submitted as part of an investigational new drug application 
(IND), or an original or supplemental new drug application (NDA), 
abbreviated new drug application (ANDA), or biologics license 
application (BLA) reviewed by the Center for Drug Evaluation and 
Research (CDER), where that technology meets certain criteria described 
in the guidance.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by February 22, 2016.

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,

[[Page 79908]]

if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-D-4644 for ``Advancement of Emerging Technology Applications 
to Modernize the Pharmaceutical Manufacturing Base.'' 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.

FOR FURTHER INFORMATION CONTACT: Sau L. Lee, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 4144, Silver Spring, MD 20993-0002, 301-796-2905; or for 
further information or to submit requests to participate in the 
program, please use [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Advancement of Emerging Technology Applications to Modernize 
the Pharmaceutical Manufacturing Base.'' The Office of Pharmaceutical 
Quality and Office of Compliance, CDER, are committed to supporting and 
enabling the modernization of pharmaceutical manufacturing as part of 
the Agency's mission to protect and promote the public health. While 
the implementation of emerging technology is critical to modernizing 
pharmaceutical manufacturing and improving quality, FDA also recognizes 
that innovative approaches to manufacturing may represent challenges to 
industry and regulators. By the very nature of an approach being 
innovative, a limited knowledge and experiential base about the 
technology may exist. Pharmaceutical companies may have concerns that 
using such technologies could result in delays while FDA reviewers 
familiarize themselves with the new technologies and determine how they 
fit within existing regulatory approaches. Through CDER's Emerging 
Technology Team, FDA intends to encourage the adoption of innovative 
approaches to pharmaceutical manufacturing by leveraging existing 
resources within the Agency to facilitate the regulatory review of 
submissions to the Agency involving manufacturing technologies likely 
to improve product safety, identity, strength, quality, and purity.
    The draft guidance provides recommendations to pharmaceutical 
companies interested in participating in a program involving the 
submission of CMC information containing emerging manufacturing 
technology to FDA. Acceptance of a request to participate in this CDER 
program will depend on the applicant's proposed plan for submission of 
an IND or original or supplemental ANDA, BLA, or NDA, based on certain 
criteria described in the guidance. To be considered for inclusion in 
the program, the proposal should be for an innovative or novel product, 
manufacturing process, and/or testing technology that is subject to CMC 
review, and for which the Agency has limited review or inspection 
experience.
    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 Advancement of 
Emerging Technology Applications to Modernize the Pharmaceutical 
Manufacturing Base. 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. The Paperwork Reduction Act of 1995

    This draft 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 information to be included in a meeting request for a 
product submitted in an IND, BLA, or NDA is approved under OMB control 
number 0910-0429 (Guidance for Industry on Formal Meetings Between the 
FDA and Sponsors or Applicants). Information to be included in a 
meeting request for a product submitted in an ANDA is approved under 
OMB control number 0910-0797 (Guidance on Controlled Correspondence 
Related to Generic Drug Development). The submission of INDs under 21 
CFR 312.23 is approved under OMB control number 0910-0014; the 
submission of BLAs under 21 CFR 601.2 and 601.12 is approved under OMB 
control number 0910-0338; and the submission of NDAs and ANDAs under 21 
CFR 314.50, 314.70, 314.71, 314.94, and 314.97 are approved under OMB 
control number 0910-0001.

III. 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.

    Dated: December 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-32316 Filed 12-22-15; 8:45 am]
BILLING CODE 4164-01-P