82 FR 45594 - Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 188 (September 29, 2017)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization.'' This guidance finalizes the draft guidance issued December 23, 2015, which provides recommendations to pharmaceutical companies interested in participating in a program involving the submission of emerging manufacturing technology. The program is open to companies that intend to include the technology as part of a regulatory submission including an investigational new drug application (IND), original or supplemental new drug application (NDA), abbreviated new drug application (ANDA) or biologic license application (BLA), or application-associated Drug Master File (DMF) reviewed by the Center for Drug Evaluation and Research (CDER), and where that technology meets other criteria described in this guidance.

[Federal Register Volume 82, Number 188 (Friday, September 29, 2017)]
[Notices]
[Pages 45594-45596]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-20861]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Advancement of Emerging Technology Applications for 
Pharmaceutical Innovation and Modernization; 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 guidance for industry entitled ``Advancement of 
Emerging Technology Applications for Pharmaceutical Innovation and 
Modernization.'' This guidance finalizes the draft guidance

[[Page 45595]]

issued December 23, 2015, which provides recommendations to 
pharmaceutical companies interested in participating in a program 
involving the submission of emerging manufacturing technology. The 
program is open to companies that intend to include the technology as 
part of a regulatory submission including an investigational new drug 
application (IND), original or supplemental new drug application (NDA), 
abbreviated new drug application (ANDA) or biologic license application 
(BLA), or application-associated Drug Master File (DMF) reviewed by the 
Center for Drug Evaluation and Research (CDER), and where that 
technology meets other criteria described in this guidance.

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

ADDRESSES: You may submit comments 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-4644 for ``Advancement of Emerging Technology Applications 
for Pharmaceutical Innovation and Modernization.'' 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 
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.
    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. 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: Sau L. Lee, Center for Drug Evaluation 
and Research, Food and Drug Administration, Bldg. 22, Rm. 2128, 10903 
New Hampshire Ave., Silver Spring, MD 20993-0002, 240-506-9136; 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 guidance for industry 
entitled ``Advancement of Emerging Technology Applications for 
Pharmaceutical Innovation and Modernization.'' FDA is committed to 
supporting and enabling pharmaceutical innovation and modernization as 
part of the Agency's mission to protect and promote the public health. 
While the implementation of emerging technology is critical to 
advancing product design, modernizing pharmaceutical manufacturing, and 
improving quality, FDA also recognizes that the adoption of innovative 
approaches may represent challenges to industry and the Agency.
    Issues in pharmaceutical manufacturing have the potential to 
significantly impact patient care as failures in quality may result in 
product recalls and harm to patients. Additionally, product failures or 
facility, equipment, or manufacturing problems are a major factor 
leading to disruptions in drug supply. Modernizing manufacturing 
technology may lead to a more robust manufacturing process with fewer 
interruptions in production, fewer product failures (before or after 
distribution), and greater assurance that the drug products 
manufactured in any given period of time will provide the expected 
clinical performance. Encouraging development of emerging technology 
may lead to pharmaceutical innovation and modernization, such as a more 
robust drug product design and improved manufacturing with better 
process control, thereby leading to improved product quality and 
availability throughout a product's lifecycle.
    In this program, pharmaceutical companies can, prior to the 
regulatory submission, submit questions and proposals about the use of 
specific emerging technology to a group within

[[Page 45596]]

the FDA Emerging Technology Team (ETT), which includes relevant 
representation from all FDA pharmaceutical quality functions. The ETT 
works in partnership with relevant pharmaceutical quality offices and 
assumes a leadership or co-leadership role for the cross-functional 
quality assessment team (including review and on-site facility 
evaluation or inspection) for submissions involving emerging 
technology.
    This guidance finalizes the draft guidance issued December 23, 2015 
(80 FR 79907). It provides further clarification on the criteria that 
the proposed technology needs to meet for its acceptance into the 
Emerging Technology Program. It also clarifies types of novel 
technology (e.g., product technology, manufacturing process, and 
control strategy) that can be covered by the program.
    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 advancement of emerging technology 
applications for pharmaceutical innovation and modernization. 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 guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
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 by 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 by 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 by OMB control number 0910-0014; the submission of BLAs 
under 21 CFR 601.2 and 601.12 is approved by 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 is approved by OMB control number 0910-0001.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: September 22, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20861 Filed 9-28-17; 8:45 am]
 BILLING CODE 4164-01-P