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)
Food and Drug Administration
Federal Register Volume 82, Issue 188 (September 29, 2017)
| Page Range | 45594-45596 | |
| FR Document | 2017-20861 |
[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] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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 This guidance finalizes the draft guidance [[Page 45595]] issued December 23, 2015, which provides recommendations to pharmaceutical companies interested in participating in a program involving the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
![45594 Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Notices
2017–D–2165 for ‘‘Oncology your requests. See the SUPPLEMENTARY labeling recommendations for oncology
Pharmaceuticals: Reproductive Toxicity INFORMATION section for electronic pharmaceuticals. It does not establish
Testing and Labeling Recommendations; access to the draft guidance document. any rights for any person and is not
Draft Guidance for Industry; FOR FURTHER INFORMATION CONTACT: John binding on FDA or the public. You can
Availability.’’ Received comments will Leighton, Center for Drug Evaluation use an alternative approach if it satisfies
be placed in the docket and, except for and Research, Food and Drug the requirements of the applicable
those submitted as ‘‘Confidential Administration, 10903 New Hampshire statutes and regulations. This is not a
Submissions,’’ publicly viewable at Ave., Bldg. 22, Rm. 2204, Silver Spring, significant regulatory action subject to
https://www.regulations.gov/ or at the MD 20993–0002, 301–796–0750; or Executive Order 12866.
Division of Dockets Management Haleh Saber, Center for Drug Evaluation
between 9 a.m. and 4 p.m., Monday II. The Paperwork Reduction Act of
and Research, Food and Drug 1995
through Friday. Administration, 10903 New Hampshire
• Confidential Submissions—To Ave., Bldg. 22, Rm. 2117, Silver Spring, This guidance refers to previously
submit a comment with confidential MD 20993–0002, 301–796–0750. approved collections of information that
information that you do not wish to be are subject to review by the Office of
SUPPLEMENTARY INFORMATION:
made publicly available, submit your Management and Budget (OMB) under
comments only as a written/paper I. Background the Paperwork Reduction Act of 1995
submission. You should submit two (44 U.S.C. 3501–3520). The collections
FDA is announcing the availability of
copies total. One copy will include the of information in 21 CFR parts 312 and
a draft guidance for industry entitled
information you claim to be confidential 314 have been approved under OMB
‘‘Oncology Pharmaceuticals:
with a heading or cover note that states control numbers 0910–0014 and 0910–
Reproductive Toxicity Testing and
‘‘THIS DOCUMENT CONTAINS 0001, respectively. The collections of
Labeling Recommendations.’’ This
CONFIDENTIAL INFORMATION.’’ The information in 21 CFR 201.56, 201.57,
guidance presents FDA’s current
Agency will review this copy, including and the final rule ‘‘Content and Format
approach to assessing potential risks to
the claimed confidential information, in of Labeling for Human Prescription
its consideration of comments. The embryo-fetal development associated
with oncology pharmaceutical use in Drug and Biological Products;
second copy, which will have the Requirements for Pregnancy and
claimed confidential information male and female patients. The term
pharmaceutical in this guidance refers Lactation Labeling’’ have been approved
redacted/blacked out, will be available under OMB control numbers 0910–0572
for public viewing and posted on to small molecules, therapeutic
proteins, antibodies, and related and 0910–0624.
https://www.regulations.gov/. Submit
both copies to the Division of Dockets products such as conjugated products. III. Electronic Access
Management. If you do not wish your The guidance describes when embryo- Persons with access to the Internet
name and contact information to be fetal developmental studies for oncology may obtain the draft guidance at either
made publicly available, you can pharmaceuticals may be warranted for https://www.fda.gov/Drugs/Guidance
provide this information on the cover different types of pharmaceuticals, such ComplianceRegulatoryInformation/
sheet and not in the body of your as cytotoxic, biological, and conjugated Guidances/default.htm or https://
comments and you must identify this pharmaceuticals, or pharmaceuticals www.regulations.gov/.
information as ‘‘confidential.’’ Any used in combinations. The guidance
also discusses other aspects of a Dated: September 22, 2017.
information marked as ‘‘confidential’’ Anna K. Abram,
will not be disclosed except in nonclinical reproductive toxicity
evaluation, such as fertility and pre- and Deputy Commissioner for Policy, Planning,
accordance with 21 CFR 10.20 and other Legislation, and Analysis.
applicable disclosure law. For more postnatal evaluation. The guidance
addresses the need for a reproductive [FR Doc. 2017–20906 Filed 9–28–17; 8:45 am]
information about FDA’s posting of
comments to public dockets, see 80 FR toxicity evaluation when BILLING CODE 4164–01–P
56469, September 18, 2015, or access pharmaceuticals are used in specific
the information at: https://www.gpo.gov/ populations (e.g., pediatric, males-only,
or postmenopausal women). DEPARTMENT OF HEALTH AND
fdsys/pkg/FR-2015-09-18/pdf/2015-
Although current regulatory HUMAN SERVICES
23389.pdf.
Docket: For access to the docket to guidances exist regarding the need to
Food and Drug Administration
read background documents or the assess the embryo-fetal developmental
electronic and written/paper comments toxicity potential of pharmaceuticals [Docket No. FDA–2015–D–4644]
received, go to https:// and the overall design of the studies,
www.regulations.gov/ and insert the this guidance provides additional Advancement of Emerging Technology
docket number, found in brackets in the recommendations on specific types of Applications for Pharmaceutical
heading of this document, into the products and for specific populations, Innovation and Modernization;
‘‘Search’’ box and follow the prompts which are not covered under other Guidance for Industry; Availability
and/or go to the Division of Dockets guidances. In addition, this guidance AGENCY: Food and Drug Administration,
Management, 5630 Fishers Lane, Rm. provides recommendations on the use of HHS.
1061, Rockville, MD 20852. contraception and the duration of its use ACTION: Notice of availability.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Submit written requests for single to minimize the potential risks
copies of the draft guidance to the associated with the use of oncology SUMMARY: The Food and Drug
Division of Drug Information, Center for pharmaceuticals. Administration (FDA or Agency) is
Drug Evaluation and Research, Food This draft guidance is being issued announcing the availability of a
and Drug Administration, 10001 New consistent with FDA’s good guidance guidance for industry entitled
Hampshire Ave., Hillandale Building, practices regulation (21 CFR 10.115). ‘‘Advancement of Emerging Technology
4th Floor, Silver Spring, MD 20993– The draft guidance, when finalized, will Applications for Pharmaceutical
0002. Send one self-addressed adhesive represent the current thinking of FDA Innovation and Modernization.’’ This
label to assist that office in processing on reproductive toxicity testing and guidance finalizes the draft guidance
VerDate Sep<11>2014 18:50 Sep 28, 2017 Jkt 241001 PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 E:\FR\FM\29SEN1.SGM 29SEN1](https://thefederalregister.org/doc/82_FR_45782/page/1.svg)
![45596 Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Notices
the FDA Emerging Technology Team III. Electronic Access before November 15, 2017. The https://
(ETT), which includes relevant Persons with access to the Internet www.regulations.gov electronic filing
representation from all FDA may obtain the guidance at either system will accept comments until
pharmaceutical quality functions. The https://www.fda.gov/Drugs/ midnight Eastern Time at the end of
ETT works in partnership with relevant GuidanceCompliance November 15, 2017. Comments received
pharmaceutical quality offices and RegulatoryInformation/Guidances/ by mail/hand delivery/courier (for
assumes a leadership or co-leadership default.htm or https://www.regulations. written/paper submissions) will be
role for the cross-functional quality gov. considered timely if they are
assessment team (including review and postmarked or the delivery service
Dated: September 22, 2017.
on-site facility evaluation or inspection) acceptance receipt is on or before that
for submissions involving emerging Anna K. Abram, date.
technology. Deputy Commissioner for Policy, Planning, Comments received on or before
Legislation, and Analysis. November 1, 2017, will be provided to
This guidance finalizes the draft
[FR Doc. 2017–20861 Filed 9–28–17; 8:45 am] the committee. Comments received after
guidance issued December 23, 2015 (80
FR 79907). It provides further BILLING CODE 4164–01–P that date will be taken into
clarification on the criteria that the consideration by FDA.
proposed technology needs to meet for You may submit comments as
DEPARTMENT OF HEALTH AND follows:
its acceptance into the Emerging
HUMAN SERVICES
Technology Program. It also clarifies Electronic Submissions
types of novel technology (e.g., product Food and Drug Administration
technology, manufacturing process, and Submit electronic comments in the
control strategy) that can be covered by [Docket No. FDA–2017–N–5315] following way:
• Federal eRulemaking Portal:
the program.
Antimicrobial Drugs Advisory https://www.regulations.gov. Follow the
This guidance is being issued Committee; Notice of Meeting; instructions for submitting comments.
consistent with FDA’s good guidance Establishment of a Public Docket; Comments submitted electronically,
practices regulation (21 CFR 10.115). Request for Comments including attachments, to https://
The guidance represents the current www.regulations.gov will be posted to
thinking of FDA on advancement of AGENCY: Food and Drug Administration,
the docket unchanged. Because your
emerging technology applications for HHS.
comment will be made public, you are
pharmaceutical innovation and ACTION: Notice; establishment of a solely responsible for ensuring that your
modernization. It does not establish any public docket; request for comments. comment does not include any
rights for any person and is not binding confidential information that you or a
on FDA or the public. You can use an SUMMARY: The Food and Drug
Administration (FDA) announces a third party may not wish to be posted,
alternative approach if it satisfies the such as medical information, your or
requirements of the applicable statutes forthcoming public advisory committee
meeting of the Antimicrobial Drugs anyone else’s Social Security number, or
and regulations. confidential business information, such
Advisory Committee. The general
II. The Paperwork Reduction Act of function of the committee is to provide as a manufacturing process. Please note
1995 advice and recommendations to FDA on that if you include your name, contact
regulatory issues. The meeting will be information, or other information that
This guidance refers to previously identifies you in the body of your
approved collections of information open to the public. FDA is establishing
a docket for public comment on this comments, that information will be
found in FDA regulations. These posted on https://www.regulations.gov.
collections of information are subject to document.
• If you want to submit a comment
review by the Office of Management and DATES: The meeting will be held on
with confidential information that you
Budget (OMB) under the Paperwork November 16, 2017, from 8:30 a.m. to 4 do not wish to be made available to the
Reduction Act of 1995 (44 U.S.C. 3501– p.m. public, submit the comment as a
3520). The information to be included ADDRESSES: FDA White Oak Campus, written/paper submission and in the
in a meeting request for a product 10903 New Hampshire Ave., Bldg. 31 manner detailed (see ‘‘Written/Paper
submitted in an IND, BLA, or NDA is Conference Center, the Great Room (Rm. Submissions’’ and ‘‘Instructions’’).
approved by OMB control number 1503), Silver Spring, MD 20993–0002.
0910–0429 (‘‘Guidance for Industry on Answers to commonly asked questions Written/Paper Submissions
Formal Meetings Between the FDA and including information regarding special Submit written/paper submissions as
Sponsors or Applicants’’). Information accommodations due to a disability, follows:
to be included in a meeting request for visitor parking, and transportation may • Mail/Hand delivery/Courier (for
a product submitted in an ANDA is be accessed at: https://www.fda.gov/ written/paper submissions): Dockets
approved by OMB control number AdvisoryCommittees/ Management Staff (HFA–305), Food and
0910–0797 (‘‘Guidance on Controlled AboutAdvisoryCommittees/ Drug Administration, 5630 Fishers
Correspondence Related to Generic Drug ucm408555.htm. Lane, Rm. 1061, Rockville, MD 20852.
Development’’). The submission of INDs FDA is establishing a docket for • For written/paper comments
asabaliauskas on DSKBBXCHB2PROD with NOTICES
under 21 CFR 312.23 is approved by public comment on this meeting. The submitted to the Dockets Management
OMB control number 0910–0014; the docket number is FDA–2017–N–5315. Staff, FDA will post your comment, as
submission of BLAs under 21 CFR 601.2 The docket will close on November 15, well as any attachments, except for
and 601.12 is approved by OMB control 2017. Submit either electronic or information submitted, marked and
number 0910–0338; and the submission written comments on this public identified, as confidential, if submitted
of NDAs and ANDAs under 21 CFR meeting by November 15, 2017. Please as detailed in ‘‘Instructions.’’
314.50, 314.70, 314.71, 314.94, and note that late, untimely filed comments Instructions: All submissions received
314.97 is approved by OMB control will not be considered. Electronic must include the Docket No. FDA–
number 0910–0001. comments must be submitted on or 2017–N–5315 for ‘‘Antimicrobial Drugs
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Document Created: 2017-09-29 03:27:25
Document Modified: 2017-09-29 03:27:25
| 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 Agency guidances at any time. | |
| 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] | |
| FR Citation | 82 FR 45594 |
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