82 FR 47749 - ``Determining Whether To Submit an Abbreviated New Drug Application or a 505(b)(2) Application;'' Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 197 (October 13, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 197 (October 13, 2017)
| Page Range | 47749-47750 | |
| FR Document | 2017-22196 |
[Federal Register Volume 82, Number 197 (Friday, October 13, 2017)] [Notices] [Pages 47749-47750] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-22196] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-5974] ``Determining Whether To Submit an Abbreviated New Drug Application or a 505(b)(2) Application;'' Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Determining Whether to Submit an ANDA or a 505(b)(2) Application.'' This guidance is intended to serve as a foundational guidance to assist applicants in determining which one of the abbreviated approval pathways under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) is appropriate for the submission of a marketing application to FDA. DATES: Submit either electronic or written comments on the draft guidance by December 12, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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: 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): 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-2017-D-5974 for ``Determining Whether to Submit an ANDA or a 505(b)(2) Application.'' 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 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 http://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 http://www.regulations.gov and insert the [[Page 47750]] 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 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: Elizabeth Giaquinto Friedman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Rm. 1670, Silver Spring, MD 20993, 240-402-7930, [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Determining Whether to Submit an ANDA or a 505(b)(2) Application.'' This guidance is intended to serve as a foundational guidance to assist applicants in determining which one of the abbreviated approval pathways under the FD&C Act is appropriate for the submission of a marketing application to FDA. This guidance highlights criteria for submitting applications under the abbreviated approval pathways described in section 505(j) and 505(b)(2) of the FD&C Act (21 U.S.C. 355(j) and 21 U.S.C. 355(b)(2), respectively), identifies considerations to help potential applicants determine whether an application would be more appropriately submitted under section 505(j) or under section 505(b)(2) of the FD&C Act, and provides direction to potential applicants on requesting assistance from FDA in making this determination. The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the Hatch-Waxman Amendments) added section 505(b)(2) and 505(j) of the FD&C Act, which describe abbreviated approval pathways for drug products regulated by the Agency under the FD&C Act. The Hatch-Waxman Amendments reflect Congress's efforts to balance the need to ``make available more low cost generic drugs by establishing a generic drug approval procedure'' with new incentives for drug development in the form of exclusivities and patent term extensions. With the passage of the Hatch-Waxman Amendments, the FD&C Act describes different routes for obtaining approval of two broad categories of drug applications: New drug applications (NDAs) and abbreviated new drug applications (ANDAs). This guidance focuses on those applications that can be submitted as ANDAs under section 505(j) of the FD&C Act, petitioned ANDAs under section 505(j)(2)(C) of the FD&C Act, or NDAs under section 505(b)(2) of the FD&C Act. This guidance does not discuss stand-alone NDAs. 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 factors for applicants to consider when determining whether to submit an ANDA or a 505(b)(2) application. 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. Paperwork Reduction Act of 1995 This draft 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 collections of information in 21 CFR 314.94 have been approved under OMB control number 0910-0001. The collection of information for controlled correspondence and pre-ANDA meeting requests has been approved under OMB control number 0910-0797. 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 October 10, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-22196 Filed 10-12-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Notices 47749
guidance concerns the implementation DEPARTMENT OF HEALTH AND Written/Paper Submissions
of the Prescription Drug User Fee HUMAN SERVICES Submit written/paper submissions as
Amendments of 2017 (PDUFA VI) and follows:
certain proposed changes in policies Food and Drug Administration • Mail/Hand delivery/Courier (for
and procedures surrounding its [Docket No. FDA–2017–D–5974] written/paper submissions): Dockets
application. Because PDUFA VI created Management Staff (HFA–305), Food and
significant changes to the user fee ‘‘Determining Whether To Submit an Drug Administration, 5630 Fishers
program, this draft guidance serves to Abbreviated New Drug Application or a Lane, Rm. 1061, Rockville, MD 20852.
provide an explanation about the new 505(b)(2) Application;’’ Draft Guidance • For written/paper comments
fee structure and types of fees for which for Industry; Availability submitted to the Dockets Management
applicants are responsible. AGENCY: Food and Drug Administration, Staff, FDA will post your comment, as
PDUFA VI provides two different fee HHS. well as any attachments, except for
ACTION: Notice of availability. information submitted, marked and
types that applicants pay: application
identified, as confidential, if submitted
and program fees. This draft guidance
SUMMARY: The Food and Drug as detailed in ‘‘Instructions.’’
describes when these fees are incurred Instructions: All submissions received
Administration (FDA or Agency) is
and the process for which applicants announcing the availability of a draft must include the Docket No. FDA–
can submit payments. The draft guidance for industry entitled 2017–D–5974 for ‘‘Determining Whether
guidance also provides information on ‘‘Determining Whether to Submit an to Submit an ANDA or a 505(b)(2)
consequences of failing to pay PDUFA ANDA or a 505(b)(2) Application.’’ This Application.’’ Received comments will
VI fees as well as the process for guidance is intended to serve as a be placed in the docket and, except for
submitting a reconsideration and foundational guidance to assist those submitted as ‘‘Confidential
appeals request. applicants in determining which one of Submissions,’’ publicly viewable at
This draft guidance is being issued the abbreviated approval pathways http://www.regulations.gov or at the
consistent with FDA’s good guidance under the Federal Food, Drug, and Dockets Management Staff between 9
practices regulation (21 CFR 10.115). Cosmetic Act (the FD&C Act) is a.m. and 4 p.m., Monday through
The draft guidance, when finalized, will appropriate for the submission of a Friday.
represent the current thinking of FDA marketing application to FDA. • Confidential Submissions—To
on assessing user fees under the DATES: Submit either electronic or submit a comment with confidential
written comments on the draft guidance information that you do not wish to be
Prescription Drug User Fee
by December 12, 2017 to ensure that the made publicly available, submit your
Amendments of 2017. It does not
Agency considers your comment on this comments only as a written/paper
establish any rights for any person and
draft guidance before it begins work on submission. You should submit two
is not binding on FDA or the public. copies total. One copy will include the
You can use an alternative approach if the final version of the guidance.
ADDRESSES: You may submit comments information you claim to be confidential
it satisfies the requirements of the with a heading or cover note that states
applicable statutes and regulations. This on any guidance at any time as follows:
‘‘THIS DOCUMENT CONTAINS
guidance is not subject to Executive Electronic Submissions CONFIDENTIAL INFORMATION.’’ The
Order 12866. Submit electronic comments in the Agency will review this copy, including
II. Electronic Access following way: the claimed confidential information, in
• Federal eRulemaking Portal: http:// its consideration of comments. The
Persons with access to the internet www.regulations.gov. Follow the second copy, which will have the
may obtain the draft guidance at either instructions for submitting comments. claimed confidential information
https://www.fda.gov/Drugs/ Comments submitted electronically, redacted/blacked out, will be available
GuidanceCompliance including attachments, to http:// for public viewing and posted on http://
RegulatoryInformation/Guidances/ www.regulations.gov will be posted to www.regulations.gov. Submit both
default.htm, https://www.fda.gov/ the docket unchanged. Because your copies to the Dockets Management Staff.
BiologicsBloodVaccines/ comment will be made public, you are If you do not wish your name and
GuidanceCompliance solely responsible for ensuring that your contact information to be made publicly
RegulatoryInformation/Guidances/ comment does not include any available, you can provide this
default.htm, or https:// confidential information that you or a information on the cover sheet and not
third party may not wish to be posted, in the body of your comments and you
www.regulations.gov.
such as medical information, your or must identify this information as
Dated: October 10, 2017. anyone else’s Social Security number, or ‘‘confidential.’’ Any information marked
Anna K. Abram, confidential business information, such as ‘‘confidential’’ will not be disclosed
Deputy Commissioner for Policy, Planning, as a manufacturing process. Please note except in accordance with 21 CFR 10.20
Legislation, and Analysis. that if you include your name, contact and other applicable disclosure law. For
[FR Doc. 2017–22192 Filed 10–12–17; 8:45 am] information, or other information that more information about FDA’s posting
BILLING CODE 4164–01–P
identifies you in the body of your of comments to public dockets, see 80
asabaliauskas on DSKBBXCHB2PROD with NOTICES
comments, that information will be FR 56469, September 18, 2015, or access
posted on http://www.regulations.gov. the information at: https://www.gpo.gov/
• If you want to submit a comment fdsys/pkg/FR-2015-09-18/pdf/2015-
with confidential information that you 23389.pdf.
do not wish to be made available to the Docket: For access to the docket to
public, submit the comment as a read background documents or the
written/paper submission and in the electronic and written/paper comments
manner detailed (see ‘‘Written/Paper received, go to http://
Submissions’’ and ‘‘Instructions’’). www.regulations.gov and insert the
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![47750 Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Notices
docket number, found in brackets in the approval procedure’’ with new DEPARTMENT OF HEALTH AND
heading of this document, into the incentives for drug development in the HUMAN SERVICES
‘‘Search’’ box and follow the prompts form of exclusivities and patent term
and/or go to the Dockets Management extensions. With the passage of the Food and Drug Administration
Staff, 5630 Fishers Lane, Rm. 1061, Hatch-Waxman Amendments, the FD&C [Docket No. FDA–2017–N–5991]
Rockville, MD 20852. Act describes different routes for
You may submit comments on any obtaining approval of two broad Agricultural Biotechnology Education
guidance at any time (see 21 CFR categories of drug applications: New and Outreach Initiative; Public
10.115(g)(5)). drug applications (NDAs) and Meetings; Request for Comments
Submit written requests for single abbreviated new drug applications
copies of the draft guidance to the (ANDAs). AGENCY: Food and Drug Administration,
Division of Drug Information, Center for HHS.
This guidance focuses on those ACTION: Notice of public meetings;
Drug Evaluation and Research, Food applications that can be submitted as
and Drug Administration, 10001 New request for comments.
ANDAs under section 505(j) of the
Hampshire Ave., Hillandale Building, FD&C Act, petitioned ANDAs under SUMMARY: The Food and Drug
4th Floor, Silver Spring, MD 20993– section 505(j)(2)(C) of the FD&C Act, or Administration (FDA or we) is
0002. Send one self-addressed adhesive NDAs under section 505(b)(2) of the announcing the following public
label to assist that office in processing FD&C Act. This guidance does not meetings entitled ‘‘Agricultural
your requests. See the SUPPLEMENTARY discuss stand-alone NDAs. Biotechnology Education and Outreach
INFORMATION section for electronic
This draft guidance is being issued Initiative.’’ The purpose of the public
access to the draft guidance document.
consistent with FDA’s good guidance meetings is to provide the public with
FOR FURTHER INFORMATION CONTACT: an opportunity to share information,
practices regulation (21 CFR 10.115).
Elizabeth Giaquinto Friedman, Center experiences, and suggestions to help
The draft guidance, when finalized, will
for Drug Evaluation and Research, Food inform the development of this
represent the current thinking of FDA
and Drug Administration, 10903 New education and outreach initiative.
on factors for applicants to consider
Hampshire Ave., Rm. 1670, Silver DATES: The public meetings will be held
when determining whether to submit an
Spring, MD 20993, 240–402–7930, on November 7, 2017, in Charlotte,
ANDA or a 505(b)(2) application. It does
elizabeth.giaquinto@fda.hhs.gov. North Carolina, and on November 14,
not establish any rights for any person
SUPPLEMENTARY INFORMATION: and is not binding on FDA or the public. 2017, in San Francisco, California.
I. Background You can use an alternative approach if Submit either electronic or written
it satisfies the requirements of the comments by November 17, 2017. See
FDA is announcing the availability of the SUPPLEMENTARY INFORMATION section
applicable statutes and regulations. This
a draft guidance for industry entitled for registration date and information.
guidance is not subject to Executive
‘‘Determining Whether to Submit an
Order 12866. ADDRESSES: The public meetings will be
ANDA or a 505(b)(2) Application.’’ This
held at:
guidance is intended to serve as a II. Paperwork Reduction Act of 1995 • The Omni Charlotte, 132 East Trade
foundational guidance to assist St., Charlotte, NC 28202 on November 7,
applicants in determining which one of This draft guidance refers to
previously approved collections of 2017, and
the abbreviated approval pathways • The San Francisco Marriott
under the FD&C Act is appropriate for information found in FDA regulations.
Marquis, 780 Mission St., San
the submission of a marketing These collections of information are
Francisco, CA 94103 on November 14,
application to FDA. This guidance subject to review by the Office of
2017.
highlights criteria for submitting Management and Budget (OMB) under
You may submit comments as
applications under the abbreviated the Paperwork Reduction Act of 1995
follows. Please note that late, untimely
approval pathways described in section (44 U.S.C. 3501–3520). The collections
filed comments will not be considered.
505(j) and 505(b)(2) of the FD&C Act (21 of information in 21 CFR 314.94 have
Electronic comments must be submitted
U.S.C. 355(j) and 21 U.S.C. 355(b)(2), been approved under OMB control
on or before November 17, 2017. The
respectively), identifies considerations number 0910–0001. The collection of
https://www.regulations.gov electronic
to help potential applicants determine information for controlled
filing system will accept comments
whether an application would be more correspondence and pre-ANDA meeting
until midnight Eastern Time at the end
appropriately submitted under section requests has been approved under OMB
of November 17, 2017. Comments
505(j) or under section 505(b)(2) of the control number 0910–0797.
received by mail/hand delivery/courier
FD&C Act, and provides direction to III. Electronic Access (for written/paper submissions) will be
potential applicants on requesting considered timely if they are
assistance from FDA in making this Persons with access to the Internet postmarked or the delivery service
determination. may obtain the draft guidance at either acceptance receipt is on or before that
The Drug Price Competition and http://www.fda.gov/Drugs/ date.
Patent Term Restoration Act of 1984 GuidanceCompliance
(Pub. L. 98–417) (the Hatch-Waxman RegulatoryInformation/Guidances/ Electronic Submissions
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Amendments) added section 505(b)(2) default.htm or http:// Submit electronic comments in the
and 505(j) of the FD&C Act, which www.regulations.gov. following way:
describe abbreviated approval pathways • Federal eRulemaking Portal:
Dated October 10, 2017.
for drug products regulated by the https://www.regulations.gov. Follow the
Agency under the FD&C Act. The Hatch- Anna K. Abram, instructions for submitting comments.
Waxman Amendments reflect Deputy Commissioner for Policy, Planning, Comments submitted electronically,
Congress’s efforts to balance the need to Legislation, and Analysis. including attachments, to https://
‘‘make available more low cost generic [FR Doc. 2017–22196 Filed 10–12–17; 8:45 am] www.regulations.gov will be posted to
drugs by establishing a generic drug BILLING CODE 4164–01–P the docket unchanged. Because your
VerDate Sep<11>2014 18:05 Oct 12, 2017 Jkt 244001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\13OCN1.SGM 13OCN1](https://thefederalregister.org/doc/82_FR_47946/page/2.svg)
Document Created: 2017-10-13 04:33:23
Document Modified: 2017-10-13 04:33:23
| 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 12, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Elizabeth Giaquinto Friedman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Rm. 1670, Silver Spring, MD 20993, 240-402-7930, [email protected] | |
| FR Citation | 82 FR 47749 |
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