83 FR 48432 - Abbreviated New Drug Application Submissions-Content and Format; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 186 (September 25, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 186 (September 25, 2018)
| Page Range | 48432-48433 | |
| FR Document | 2018-20790 |
[Federal Register Volume 83, Number 186 (Tuesday, September 25, 2018)] [Notices] [Pages 48432-48433] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-20790] [[Page 48432]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-D-0725] Abbreviated New Drug Application Submissions--Content and Format; 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 final guidance for industry entitled ``ANDA Submissions--Content and Format.'' This guidance is intended to assist applicants in preparing abbreviated new drug applications (ANDAs) for submission to FDA under the Federal Food, Drug and Cosmetic Act (the FD&C Act). DATES: The announcement of the guidance is published in the Federal Register on September 25, 2018. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time 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-2014-D-0725 for ``ANDA Submissions--Content and Format.'' 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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). 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: Elizabeth Giaquinto Friedman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 240-402-7930. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ``ANDA Submissions--Content and Format of Abbreviated New Drug Applications.'' This guidance is intended to assist applicants in preparing ANDAs for submission to FDA under section 505(j) of the FD&C Act (21 U.S.C. 355(j)). This guidance details the information that should be provided in each section of the common technical document format for human pharmaceutical product applications and identifies supporting guidance documents and recommendations issued by FDA to assist applicants in preparing their ANDA submission. This guidance identifies the information an applicant should include to ensure that a complete, high-quality application is submitted to FDA. FDA has previously published guidance documents on the filing process, including the guidances for industry about refuse- to-receive standards and common, recurring deficiencies, which should be reviewed thoroughly prior to submission of an ANDA. In the Federal Register of June 12, 2014 (79 FR 33758), FDA issued the draft guidance for industry ``ANDA Submissions--Content and Format of Abbreviated New Drug Applications.'' FDA carefully considered the comments received on the draft guidance, and, where possible, has incorporated into the final guidance additional detailed discussion of our current thinking on the content and format of ANDAs submitted to FDA for review. This guidance is being issued consistent with FDA's good guidance [[Page 48433]] practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on the content and format of ANDA submissions. 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 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 (including subpart C) related to the content and format of ANDAs submitted by applicants and approved by FDA is approved under OMB control number 0910-0001. Applicant submission of controlled correspondence related to generic drug development and FDA approval is approved under OMB control number 0910- 0797. The collection of information for Form FDA 356h (NDA and ANDA cover sheet) has been approved under OMB control number 0910-0338. The collection of information for Form FDA 3674 (application certification) has been approved under OMB control number 0910-0616. The collection of information for Form FDA 3794 (GDUFA cover sheet) has been approved under OMB control number 0910-0727. The collection of information for Form FDA 3454 and Form FDA 3455 (clinical investigator financial interest) has been approved under control number 0910-0396. The submission of petitions under 21 CFR part 10 (Administrative Practices and Procedures) has been approved under OMB control number 0910-0191. The collection information in 21 CFR part 11 (electronic records) has been approved under OMB control number 0910-0303. Information about the manufacture of the drug product under 21 CFR part 211 has been approved under OMB control number 0910-0139. 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 19, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-20790 Filed 9-24-18; 8:45 am] BILLING CODE 4164-01-P
![48432 Federal Register / Vol. 83, No. 186 / Tuesday, September 25, 2018 / Notices
DEPARTMENT OF HEALTH AND • Mail/Hand Delivery/Courier (for Staff, 5630 Fishers Lane, Rm. 1061,
HUMAN SERVICES written/paper submissions): Dockets Rockville, MD 20852.
Management Staff (HFA–305), Food and You may submit comments on any
Food and Drug Administration Drug Administration, 5630 Fishers guidance at any time (see 21 CFR
Lane, Rm. 1061, Rockville, MD 20852. 10.115(g)(5)).
[Docket No. FDA–2014–D–0725] • For written/paper comments Submit written requests for single
submitted to the Dockets Management copies of this guidance to the Division
Abbreviated New Drug Application Staff, FDA will post your comment, as of Drug Information, Center for Drug
Submissions—Content and Format; well as any attachments, except for Evaluation and Research, Food and
Guidance for Industry; Availability information submitted, marked and Drug Administration, 10001 New
AGENCY: Food and Drug Administration, identified, as confidential, if submitted Hampshire Ave., Hillandale Building,
HHS. as detailed in ‘‘Instructions.’’ 4th Floor, Silver Spring, MD 20993–
Instructions: All submissions received 0002. Send one self-addressed adhesive
ACTION: Notice of availability.
must include the Docket No. FDA– label to assist that office in processing
SUMMARY: The Food and Drug 2014–D–0725 for ‘‘ANDA your requests. See the SUPPLEMENTARY
Administration (FDA or Agency) is Submissions—Content and Format.’’ INFORMATION section for electronic
announcing the availability of a final Received comments will be placed in access to the guidance document.
guidance for industry entitled ‘‘ANDA the docket and, except for those
FOR FURTHER INFORMATION CONTACT:
Submissions—Content and Format.’’ submitted as ‘‘Confidential
Elizabeth Giaquinto Friedman, Center
This guidance is intended to assist Submissions,’’ publicly viewable at
for Drug Evaluation and Research, Food
applicants in preparing abbreviated new https://www.regulations.gov or at the
and Drug Administration, 10903 New
drug applications (ANDAs) for Dockets Management Staff between 9
Hampshire Ave., Silver Spring, MD
submission to FDA under the Federal a.m. and 4 p.m., Monday through
20993, 240–402–7930.
Food, Drug and Cosmetic Act (the FD&C Friday.
• Confidential Submissions—To SUPPLEMENTARY INFORMATION:
Act).
submit a comment with confidential I. Background
DATES: The announcement of the information that you do not wish to be
guidance is published in the Federal made publicly available, submit your FDA is announcing the availability of
Register on September 25, 2018. comments only as a written/paper a guidance for industry entitled ‘‘ANDA
ADDRESSES: You may submit either submission. You should submit two Submissions—Content and Format of
electronic or written comments on copies total. One copy will include the Abbreviated New Drug Applications.’’
Agency guidances at any time as information you claim to be confidential This guidance is intended to assist
follows: with a heading or cover note that states applicants in preparing ANDAs for
‘‘THIS DOCUMENT CONTAINS submission to FDA under section 505(j)
Electronic Submissions of the FD&C Act (21 U.S.C. 355(j)). This
CONFIDENTIAL INFORMATION.’’ The
Submit electronic comments in the Agency will review this copy, including guidance details the information that
following way: the claimed confidential information, in should be provided in each section of
• Federal eRulemaking Portal: its consideration of comments. The the common technical document format
https://www.regulations.gov. Follow the second copy, which will have the for human pharmaceutical product
instructions for submitting comments. claimed confidential information applications and identifies supporting
Comments submitted electronically, redacted/blacked out, will be available guidance documents and
including attachments, to https:// for public viewing and posted on recommendations issued by FDA to
www.regulations.gov will be posted to https://www.regulations.gov. Submit assist applicants in preparing their
the docket unchanged. Because your both copies to the Dockets Management ANDA submission.
comment will be made public, you are Staff. If you do not wish your name and This guidance identifies the
solely responsible for ensuring that your contact information to be made publicly information an applicant should include
comment does not include any available, you can provide this to ensure that a complete, high-quality
confidential information that you or a information on the cover sheet and not application is submitted to FDA. FDA
third party may not wish to be posted, in the body of your comments and you has previously published guidance
such as medical information, your or must identify this information as documents on the filing process,
anyone else’s Social Security number, or ‘‘confidential.’’ Any information marked including the guidances for industry
confidential business information, such as ‘‘confidential’’ will not be disclosed about refuse-to-receive standards and
as a manufacturing process. Please note except in accordance with 21 CFR 10.20 common, recurring deficiencies, which
that if you include your name, contact and other applicable disclosure law. For should be reviewed thoroughly prior to
information, or other information that more information about FDA’s posting submission of an ANDA.
identifies you in the body of your of comments to public dockets, see 80 In the Federal Register of June 12,
comments, that information will be FR 56469, September 18, 2015, or access 2014 (79 FR 33758), FDA issued the
posted on https://www.regulations.gov. the information at: https://www.gpo.gov/ draft guidance for industry ‘‘ANDA
• If you want to submit a comment fdsys/pkg/FR-2015-09-18/pdf/2015- Submissions—Content and Format of
with confidential information that you 23389.pdf. Abbreviated New Drug Applications.’’
do not wish to be made available to the Docket: For access to the docket to FDA carefully considered the comments
public, submit the comment as a read background documents or the received on the draft guidance, and,
daltland on DSKBBV9HB2PROD with NOTICES
written/paper submission and in the electronic and written/paper comments where possible, has incorporated into
manner detailed (see ‘‘Written/Paper received, go to https:// the final guidance additional detailed
Submissions’’ and ‘‘Instructions’’). www.regulations.gov and insert the discussion of our current thinking on
docket number, found in brackets in the the content and format of ANDAs
Written/Paper Submissions heading of this document, into the submitted to FDA for review.
Submit written/paper submissions as ‘‘Search’’ box and follow the prompts This guidance is being issued
follows: and/or go to the Dockets Management consistent with FDA’s good guidance
VerDate Sep<11>2014 17:40 Sep 24, 2018 Jkt 244001 PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 E:\FR\FM\25SEN1.SGM 25SEN1](https://thefederalregister.org/doc/83_FR_48618/page/1.svg)
![Federal Register / Vol. 83, No. 186 / Tuesday, September 25, 2018 / Notices 48433
practices regulation (21 CFR 10.115). Dated: September 19, 2018. • Federal eRulemaking Portal:
The guidance represents the current Leslie Kux, https://www.regulations.gov. Follow the
thinking of FDA on the content and Associate Commissioner for Policy. instructions for submitting comments.
format of ANDA submissions. It does [FR Doc. 2018–20790 Filed 9–24–18; 8:45 am] Comments submitted electronically,
not establish any rights for any person BILLING CODE 4164–01–P including attachments, to https://
and is not binding on FDA or the public. www.regulations.gov will be posted to
You can use an alternative approach if the docket unchanged. Because your
it satisfies the requirements of the DEPARTMENT OF HEALTH AND comment will be made public, you are
applicable statutes and regulations. This HUMAN SERVICES solely responsible for ensuring that your
guidance is not subject to Executive comment does not include any
Order 12866. Food and Drug Administration confidential information that you or a
[Docket No. FDA–2018–N–3344] third party may not wish to be posted,
II. Paperwork Reduction Act of 1995 such as medical information, your or
Agency Information Collection anyone else’s Social Security number, or
This guidance refers to previously confidential business information, such
Activities; Proposed Collection;
approved collections of information as a manufacturing process. Please note
Comment Request; Adverse Event
found in FDA regulations. These that if you include your name, contact
Reporting and Recordkeeping for
collections of information are subject to Dietary Supplements as Required by information, or other information that
review by the Office of Management and the Dietary Supplement and identifies you in the body of your
Budget (OMB) under the Paperwork Nonprescription Drug Consumer comments, that information will be
Reduction Act of 1995 (44 U.S.C. 3501– Protection Act posted on https://www.regulations.gov.
3520). The collections of information in • If you want to submit a comment
21 CFR 314 (including subpart C) AGENCY: Food and Drug Administration, with confidential information that you
related to the content and format of HHS. do not wish to be made available to the
ANDAs submitted by applicants and ACTION: Notice. public, submit the comment as a
approved by FDA is approved under written/paper submission and in the
SUMMARY: The Food and Drug
OMB control number 0910–0001. manner detailed (see ‘‘Written/Paper
Administration (FDA, Agency, or we) is
Applicant submission of controlled Submissions’’ and ‘‘Instructions’’).
announcing an opportunity for public
correspondence related to generic drug comment on the proposed collection of Written/Paper Submissions
development and FDA approval is certain information by the Agency.
approved under OMB control number Submit written/paper submissions as
Under the Paperwork Reduction Act of follows:
0910–0797. 1995 (PRA), Federal Agencies are • Mail/Hand delivery/Courier (for
The collection of information for required to publish notice in the written/paper submissions): Dockets
Form FDA 356h (NDA and ANDA cover Federal Register concerning each Management Staff (HFA–305), Food and
sheet) has been approved under OMB proposed collection of information, Drug Administration, 5630 Fishers
control number 0910–0338. The including each proposed extension of an Lane, Rm. 1061, Rockville, MD 20852.
collection of information for Form FDA existing collection of information, and • For written/paper comments
3674 (application certification) has been to allow 60 days for public comment in submitted to the Dockets Management
approved under OMB control number response to the notice. This notice Staff, FDA will post your comment, as
0910–0616. The collection of solicits comments on the collection of well as any attachments, except for
information for Form FDA 3794 information associated with adverse information submitted, marked and
(GDUFA cover sheet) has been approved event reporting and recordkeeping for identified, as confidential, if submitted
under OMB control number 0910–0727. dietary supplements as required by the as detailed in ‘‘Instructions.’’
The collection of information for Form Dietary Supplement and Instructions: All submissions received
FDA 3454 and Form FDA 3455 (clinical Nonprescription Drug Consumer must include the Docket No. FDA–
investigator financial interest) has been Protection Act (DSNDCPA). 2018–N–3344 for ‘‘Agency Information
approved under control number 0910– DATES: Submit either electronic or Collection Activities; Proposed
0396. written comments on the collection of Collection; Comment Request; Adverse
information by November 26, 2018. Event Reporting and Recordkeeping for
The submission of petitions under 21
ADDRESSES: You may submit comments Dietary Supplements as Required by the
CFR part 10 (Administrative Practices
as follows. Please note that late, Dietary Supplement and
and Procedures) has been approved
untimely filed comments will not be Nonprescription Drug Consumer
under OMB control number 0910–0191.
considered. Electronic comments must Protection Act.’’ Received comments,
The collection information in 21 CFR
be submitted on or before November 26, those filed in a timely manner (see
part 11 (electronic records) has been
2018. The https://www.regulations.gov ADDRESSES), will be placed in the docket
approved under OMB control number
electronic filing system will accept and, except for those submitted as
0910–0303. Information about the
comments until midnight Eastern Time ‘‘Confidential Submissions,’’ publicly
manufacture of the drug product under
at the end of November 26, 2018. viewable at https://www.regulations.gov
21 CFR part 211 has been approved
Comments received by mail/hand or at the Dockets Management Staff
under OMB control number 0910–0139. between 9 a.m. and 4 p.m., Monday
delivery/courier (for written/paper
III. Electronic Access submissions) will be considered timely through Friday.
daltland on DSKBBV9HB2PROD with NOTICES
if they are postmarked or the delivery • Confidential Submissions—To
Persons with access to the internet service acceptance receipt is on or submit a comment with confidential
may obtain the guidance at either before that date. information that you do not wish to be
https://www.fda.gov/Drugs/Guidance made publicly available, submit your
ComplianceRegulatoryInformation/ Electronic Submissions comments only as a written/paper
Guidances/default.htm or https:// Submit electronic comments in the submission. You should submit two
www.regulations.gov. following way: copies total. One copy will include the
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Document Created: 2018-09-25 00:21:43
Document Modified: 2018-09-25 00:21:43
| 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 | The announcement of the guidance is published in the Federal Register on September 25, 2018. | |
| Contact | Elizabeth Giaquinto Friedman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 240-402-7930. | |
| FR Citation | 83 FR 48432 |
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