80 FR 79907 - Draft Guidance for Industry on Advancement of Emerging Technology Applications To Modernize the Pharmaceutical Manufacturing Base; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 246 (December 23, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 246 (December 23, 2015)
| Page Range | 79907-79908 | |
| FR Document | 2015-32316 |
[Federal Register Volume 80, Number 246 (Wednesday, December 23, 2015)] [Notices] [Pages 79907-79908] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-32316] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-4644] Draft Guidance for Industry on Advancement of Emerging Technology Applications To Modernize the Pharmaceutical Manufacturing Base; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base.''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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 22, 2016.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
![Federal Register / Vol. 80, No. 246 / Wednesday, December 23, 2015 / Notices 79907
device experience reporting is approved 0910–0014 through December 31, 2015; imposed by this proposed collection
under OMB control number 0910–0471 and investigational device exemption would be minimal.
through May 31, 2017; investigational reporting is approved under OMB FDA estimates the burden of this
new drug application regulations are control number 0910–0078 through collection of information as follows:
approved under OMB control number March 31, 2016). Any additional burden
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
No. of re- Average bur-
No. of re- Total annual
Type of respondent sponses per den per re- Total hours
spondents responses
respondent sponse
Requests to Issue an EUA or a Substantive Amendment
to an Existing EUA ........................................................... 6 3 18 45 810
FDA Review of a Pre-EUA Package or an Amendment
Thereto ............................................................................. 13 6 78 34 2,652
Manufacturers of an Unapproved EUA Product .................. 5 2 10 2 20
Public Health Authorities; Unapproved EUA Product .......... 30 3 90 2 180
Total .............................................................................. ........................ ........................ ........................ ........................ 3,662
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
No. of records Average bur-
No. of record- Total annual
Type of respondent per record- den per rec- Total hours
keepers records
keeper ordkeeping
Manufacturers of an Unapproved EUA Product .................. 5 2 10 25 250
Public Health Authorities; Unapproved EUA Product .......... 30 3 90 3 270
Total ..................................................................................... ........................ ........................ ........................ ........................ 520
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: December 17, 2015. (CMC) information containing emerging comment will be made public, you are
Leslie Kux, manufacturing technology. The program solely responsible for ensuring that your
Associate Commissioner for Policy. is open to companies that intend the comment does not include any
[FR Doc. 2015–32253 Filed 12–22–15; 8:45 am] technology to be submitted as part of an confidential information that you or a
BILLING CODE 4164–01–P investigational new drug application third party may not wish to be posted,
(IND), or an original or supplemental such as medical information, your or
new drug application (NDA), anyone else’s Social Security number, or
DEPARTMENT OF HEALTH AND abbreviated new drug application confidential business information, such
HUMAN SERVICES (ANDA), or biologics license application as a manufacturing process. Please note
(BLA) reviewed by the Center for Drug that if you include your name, contact
Food and Drug Administration Evaluation and Research (CDER), where information, or other information that
[Docket No. FDA–2015–D–4644] that technology meets certain criteria identifies you in the body of your
described in the guidance. comments, that information will be
Draft Guidance for Industry on DATES: Although you can comment on posted on http://www.regulations.gov.
Advancement of Emerging Technology any guidance at any time (see 21 CFR • If you want to submit a comment
Applications To Modernize the 10.115(g)(5)), to ensure that the Agency with confidential information that you
Pharmaceutical Manufacturing Base; considers your comment on this draft do not wish to be made available to the
Draft Guidance for Industry; guidance before it begins work on the public, submit the comment as a
Availability final version of the guidance, submit written/paper submission and in the
either electronic or written comments manner detailed (see ‘‘Written/Paper
AGENCY: Food and Drug Administration, Submissions’’ and ‘‘Instructions’’).
HHS. on the draft guidance by February 22,
2016. Written/Paper Submissions
ACTION: Notice of availability.
ADDRESSES: You may submit comments Submit written/paper submissions as
SUMMARY: The Food and Drug as follows: follows:
Administration (FDA or Agency) is • Mail/Hand delivery/Courier (for
announcing the availability of a draft Electronic Submissions written/paper submissions): Division of
guidance for industry entitled Submit electronic comments in the Dockets Management (HFA–305), Food
‘‘Advancement of Emerging Technology following way: and Drug Administration, 5630 Fishers
• Federal eRulemaking Portal: http://
tkelley on DSK3SPTVN1PROD with NOTICES
Applications to Modernize the Lane, Rm. 1061, Rockville, MD 20852.
Pharmaceutical Manufacturing Base.’’ www.regulations.gov. Follow the • For written/paper comments
This guidance provides instructions for submitting comments. submitted to the Division of Dockets
recommendations to pharmaceutical Comments submitted electronically, Management, FDA will post your
companies interested in participating in including attachments, to http:// comment, as well as any attachments,
a program involving the submission of www.regulations.gov will be posted to except for information submitted,
chemistry, manufacturing, and controls the docket unchanged. Because your marked and identified, as confidential,
VerDate Sep<11>2014 18:05 Dec 22, 2015 Jkt 238001 PO 00000 Frm 00091 Fmt 4703 Sfmt 4703 E:\FR\FM\23DEN1.SGM 23DEN1](https://thefederalregister.org/doc/80_FR_80153/page/1.svg)
![79908 Federal Register / Vol. 80, No. 246 / Wednesday, December 23, 2015 / Notices
if submitted as detailed in 4th Floor, Silver Spring, MD 20993– based on certain criteria described in
‘‘Instructions.’’ 0002. Send one self-addressed adhesive the guidance. To be considered for
Instructions: All submissions received label to assist that office in processing inclusion in the program, the proposal
must include the Docket No. FDA– your requests. See the SUPPLEMENTARY should be for an innovative or novel
2015–D–4644 for ‘‘Advancement of INFORMATION section for electronic product, manufacturing process, and/or
Emerging Technology Applications to access to the draft guidance document. testing technology that is subject to
Modernize the Pharmaceutical FOR FURTHER INFORMATION CONTACT: Sau CMC review, and for which the Agency
Manufacturing Base.’’ Received L. Lee, Center for Drug Evaluation and has limited review or inspection
comments will be placed in the docket Research, Food and Drug experience.
and, except for those submitted as Administration, 10903 New Hampshire This draft guidance is being issued
‘‘Confidential Submissions,’’ publicly Ave., Bldg. 51, Rm. 4144, Silver Spring, consistent with FDA’s good guidance
viewable at http://www.regulations.gov MD 20993–0002, 301–796–2905; or for practices regulation (21 CFR 10.115).
or at the Division of Dockets further information or to submit The draft guidance, when finalized, will
Management between 9 a.m. and 4 p.m., requests to participate in the program, represent the current thinking of FDA
Monday through Friday. please use CDER–ETT@fda.hhs.gov. on Advancement of Emerging
• Confidential Submissions—To
SUPPLEMENTARY INFORMATION: Technology Applications to Modernize
submit a comment with confidential
the Pharmaceutical Manufacturing Base.
information that you do not wish to be I. Background
made publicly available, submit your It does not establish any rights for any
comments only as a written/paper FDA is announcing the availability of person and is not binding on FDA or the
submission. You should submit two a draft guidance for industry entitled public. You can use an alternative
copies total. One copy will include the ‘‘Advancement of Emerging Technology approach if it satisfies the requirements
information you claim to be confidential Applications to Modernize the of the applicable statutes and
with a heading or cover note that states Pharmaceutical Manufacturing Base.’’ regulations.
‘‘THIS DOCUMENT CONTAINS The Office of Pharmaceutical Quality
II. The Paperwork Reduction Act of
CONFIDENTIAL INFORMATION.’’ The and Office of Compliance, CDER, are
1995
Agency will review this copy, including committed to supporting and enabling
the claimed confidential information, in the modernization of pharmaceutical This draft guidance refers to
its consideration of comments. The manufacturing as part of the Agency’s previously approved collections of
second copy, which will have the mission to protect and promote the information that are subject to review by
claimed confidential information public health. While the the Office of Management and Budget
redacted/blacked out, will be available implementation of emerging technology (OMB) under the Paperwork Reduction
for public viewing and posted on is critical to modernizing Act of 1995 (44 U.S.C. 3501–3520). The
http://www.regulations.gov. Submit pharmaceutical manufacturing and information to be included in a meeting
both copies to the Division of Dockets improving quality, FDA also recognizes request for a product submitted in an
Management. If you do not wish your that innovative approaches to IND, BLA, or NDA is approved under
name and contact information to be manufacturing may represent challenges OMB control number 0910–0429
made publicly available, you can to industry and regulators. By the very (Guidance for Industry on Formal
provide this information on the cover nature of an approach being innovative, Meetings Between the FDA and
sheet and not in the body of your a limited knowledge and experiential Sponsors or Applicants). Information to
comments and you must identify this base about the technology may exist. be included in a meeting request for a
information as ‘‘confidential.’’ Any Pharmaceutical companies may have product submitted in an ANDA is
information marked as ‘‘confidential’’ concerns that using such technologies approved under OMB control number
will not be disclosed except in could result in delays while FDA 0910–0797 (Guidance on Controlled
accordance with 21 CFR 10.20 and other reviewers familiarize themselves with Correspondence Related to Generic Drug
applicable disclosure law. For more the new technologies and determine Development). The submission of INDs
information about FDA’s posting of how they fit within existing regulatory under 21 CFR 312.23 is approved under
comments to public dockets, see 80 FR approaches. Through CDER’s Emerging OMB control number 0910–0014; the
56469, September 18, 2015, or access Technology Team, FDA intends to submission of BLAs under 21 CFR 601.2
the information at: http://www.fda.gov/ encourage the adoption of innovative and 601.12 is approved under OMB
regulatoryinformation/dockets/ approaches to pharmaceutical control number 0910–0338; and the
default.htm. manufacturing by leveraging existing submission of NDAs and ANDAs under
Docket: For access to the docket to resources within the Agency to facilitate 21 CFR 314.50, 314.70, 314.71, 314.94,
read background documents or the the regulatory review of submissions to and 314.97 are approved under OMB
electronic and written/paper comments the Agency involving manufacturing control number 0910–0001.
received, go to http:// technologies likely to improve product
www.regulations.gov and insert the safety, identity, strength, quality, and III. Electronic Access
docket number, found in brackets in the purity. Persons with access to the Internet
heading of this document, into the The draft guidance provides may obtain the draft guidance at either
‘‘Search’’ box and follow the prompts recommendations to pharmaceutical http://www.fda.gov/Drugs/Guidance
and/or go to the Division of Dockets companies interested in participating in ComplianceRegulatoryInformation/
Management, 5630 Fishers Lane, Rm. a program involving the submission of Guidances/default.htm or http://
tkelley on DSK3SPTVN1PROD with NOTICES
1061, Rockville, MD 20852. CMC information containing emerging www.regulations.gov.
Submit written requests for single manufacturing technology to FDA.
copies of the draft guidance to the Acceptance of a request to participate in Dated: December 16, 2015.
Division of Drug Information, Center for this CDER program will depend on the Leslie Kux,
Drug Evaluation and Research, Food applicant’s proposed plan for Associate Commissioner for Policy.
and Drug Administration, 10001 New submission of an IND or original or [FR Doc. 2015–32316 Filed 12–22–15; 8:45 am]
Hampshire Ave., Hillandale Building, supplemental ANDA, BLA, or NDA, BILLING CODE 4164–01–P
VerDate Sep<11>2014 18:05 Dec 22, 2015 Jkt 238001 PO 00000 Frm 00092 Fmt 4703 Sfmt 9990 E:\FR\FM\23DEN1.SGM 23DEN1](https://thefederalregister.org/doc/80_FR_80153/page/2.svg)
Document Created: 2018-03-02 09:21:21
Document Modified: 2018-03-02 09:21:21
| 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 | 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. | |
| 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] | |
| FR Citation | 80 FR 79907 |
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